Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414226
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-04-17
Brief Title:
Comparison of Krill and Fish Oil on Clinical and Biochemical Outcomes in Depression
Sponsor:
Firat University
Organization:
Firat University
Study Overview
Official Title:
Investigation of the Effect of Krill and Fish Oil Intake on Clinical and Biochemical Findings and Eating Behavior in Adult Individuals With Major Depression Disorders
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Omega-3 polyunsaturated fatty acids n-3 PUFA associated with fish oil has been one of the most studied non-pharmacological subjects for its effect on Major Depression Disorder MDD However studies comparing the effect of krill oil on depression are limited that has similar content and different structural forms with fish oil This study was conducted to evaluate the effectiveness of the use of krill and fish oil on clinical effects biochemical outcomes and eating behavior in individuals diagnosed with MDD It was included 57 adult individuals diagnosed with MDD in the psychiatry clinic in this study Randomization was performed after inclusion and exclusion criteria were applied in the study and participants were included in one of three groups These groups are 1 krill oil n17 Eicosapentaenoic acid EPA340 mg Docosahexaenoic acid DHA180 mg 2 fish oil n17 EPA360 mg DHA240 mg 3 placebo n16 EPA0 mg DHA0 mg The duration of the intervention was 8 weeks Anthropometric measurements biochemical outcomes and food consumption records of the participants were taken at the beginning and end of the intervention and Hamilton depression rating scale HDRS depression anxiety stress-21 DASS-21 and food craving questionnaire FCQ was applied to the participants Statistical Package for Social Sciences SPSS and R studio software were used for statistical analysis of the data
Detailed Description:
Introduction
Major Depressive Disorder MDD affects approximately 6 of the adult population worldwide each year and is the second greatest contributor to the burden of chronic disease In the treatment of MDD both psychotherapy and psychopharmacology are effective However approximately 30 of patients do not achieve definitive recovery even after several treatment attempts Major depressive disorder can affect an individuals life as a whole and is difficult to treat due to its high rate of relapse and it is often associated with anxiety and cardiovascular diseases CVD which can threaten an individuals life It is estimated that major depression is responsible for 3 of the global burden of disease according to the World Health Organization WHO report and that this rate may increase to 7 by 2030 Therefore alternatives to effective treatments and prevention strategies are urgently needed due to this increasing trend
Omega-3 polyunsaturated fatty acids n-3 PUFAs identified with fish oil became one of the most researched nutritional topics on the effects of major depressive disorder Omega-3 polyunsaturated fatty acids are shown to be effective in cardiovascular disease CVD prevention due to their anti-inflammatory and cardio-protective effects It can potentially share common mechanisms with CVD considering factors such as increased production of pro-inflammatory cytokines endothelial dysfunction and increases in plasma homocysteine levels which play a role in the pathophysiology of some psychiatric disorders such as depression It is possible that omega-3 has multiple positive effects on depression through its neurogenesis and neuroplasticity abilities as well as having a positive effect on pathophysiological mechanisms Appleton et al conducted a Cochrane review to investigate the effect of n-3 PUFA supplements on depression in adults This review included 25 studies total 1438 participants investigating the effect of n-3 PUFA supplements versus placebo and 1 study 40 participants comparing n-3 PUFA supplements with antidepressant treatment As a result it was reported that n-3 PUFA supplements had a modestly positive effect on depression compared to placebo However it was emphasized in this report that the majority of the studies 22 studies had a low level of evidence This was attributed to factors such as high levels of bias duration of follow-up methodological errors and deficiencies due to blinded designs The general conclusion of the authors was that there was a need for high quality intervention studies in this field
Although there are a large number of studies focusing on the use of fish oil in depression research using krill oil another source rich in n-3 PUFAs is very limited Krill oil is an important shellfish that lives in the oceans around the Antarctic continent and attracts attention in research due to its rich omega-3 fatty acid content As krill is a species living in cold regions they are rich in EPA and DHA content along with PUFAs in the form of phospholipids and especially phosphatidylcholine in cell membrane structures The form containing and binding Docosahexaenoic acid DHA and Eicosapentaenoic acid EPA in krill oil is phospholipids contrary to triglyceride in fish oil Therefore the absorption and bioavailability activities are different because of the difference in the forms in fish and krill oil Although there are studies on the effects of krill oil on the nervous system on the human research there is limited research on the effectiveness of krill oil on depression To our knowledge there was only one pilot study on rats comparing the treatment efficacy of fish and krill oil on depression This study compared the antidepressant effects of krill EPA 60 mg500 mg DHA 35 mg500 mg and fish oil EPA 90 mg500 mg DHA 60 mg500 mg vitamin B12 and imipramine As a result krill oil showed favorable results on a number of variables compared to fish oil but similar results were found in both groups It is important to compare the efficacy of krill and fish oil with similar EPA and DHA content on depression to clarify the question of which of these oils in different forms may be more effective on the disease
Major depressive disorders affect many mechanisms such as food intake taste perception and food selection When clinical pictures related to the nutritional status of depressed individuals are examined changes in appetite increased consumption of certain food groups and related changes in body weight are frequently observed In addition antidepressant drugs used may also affect food intake and weight control Eating behavior is under the control of complex neural mechanisms especially serotonin At the same time food intake is also effective in the control of serotonin release in serotonergic neurons Serotonin which has a bidirectional relationship with eating behavior is a neurotransmitter involved in the physiopathology of many psychiatric disorders The presence of a disorder in the serotonin pathway may explain the development of both psychiatric disorders and obesity in the patient As a result it was reported that eating behavior disorders interest in unhealthy food consumption and increased appetite in major depressives as in some psychiatric disorders may lead to an increase in body weight in individuals during the illness or in progressive processes There are several studies examining the relationship between depression and obesity However clinical studies to determine the factors leading to this condition are limited In addition data collection on eating behavior appetite and weight status is neglected in most clinical interventions in patients with depression Therefore it is important to investigate the efficacy of n-3 fatty acids on appetite and body composition as well as eating behaviors that examine food cravings in depressed individuals
Considering all of these opinions this study aimed to determine the effectiveness of krill and fish oil on clinical effects biochemical findings and eating behavior in individuals diagnosed with MDD and to compare the results with the control group
METHODS
This study was designed with a randomized double-blind placebo-controlled The study was conducted in the Psychiatry Clinic of Adıyaman University Training and Research Hospital with 50 patients over the age of 18 diagnosed with MDD The duration of the intervention for each participant was 8 weeks The included patients received fish oil or krill oil or placebo The study was conducted in accordance with good clinical guidelines and in accordance with the Declaration of Helsinki Ethical approval was also obtained from the Ethics Committee of Fırat University
Participants
The study was enrolled with 66 patients with MDD who were over 18 years of age and fulfilled the inclusion criteria Inclusion criteria were 1 being diagnosed with major depression by a psychiatrist in accordance with DSM V diagnostic criteria 2 not taking antidepressant medication or being on antidepressant medication for the last 1 month without medication change 3 signing the informed consent form The exclusion criteria were as follows 1 those who used more than two antidepressants 2 substance users in the last 6 months 3 alcohol dependence 4 suicidal ideation and suicidal tendencies followed up by clinicians 5 presence of other psychiatric disorders such as comorbid psychosis schizophrenia and bipolar excluding dysthymia and anxiety 6 Presence of serious chronic diseases 7 pregnant or lactating women 8 Medication users that may cause emotional symptoms EscitolopromLexopro etc 9 food allergies 10 individuals at high risk of bleeding or those taking anti-coagulant drugs such as warfarin 11 Consumers of 3 or more servings of fish per week 12 Using any nutritional supplement 13 Hypercholesterolemia or taking medication for hypercholesterolemia 14 those who did not sign the informed consent form
Sample Size and Randomization and Blinded
The sample size was determined based on the findings of a similar study using the G power 3197 software program with an effect size of 0224 95 confidence interval and a margin of error of 005
This study was a randomized controlled double-blind study design The assignment of patients to groups randomization was performed by a statistician who was not involved in the research and was concealed from the patients At the first stage stratified randomization was performed to ensure homogeneous distribution of patients according to age and gender and then simple randomization was performed from each layer to ensure equal assignment to all groups Each patient was assigned a number between 1-60 and then stratified according to gender male and female and age group 18-34 and 35-64 years In the last stage numbers were generated with the R studio statistical program to assign an equal number of patients to each group
The statistician randomly assigned the color codes on the capsule bottles to each group and each group received the test products from the researcher in a closed package according to the color codes These color codes were not known by the researchers and patients until the endpoint of the study In addition the researcher clinician and participant were blinded until the study was reported
Intervention
The researcher conducted three 45-minute interviews with the participants for 8 weeks at the beginning mid and end of the study In the first interview patients were given the product they should receive for 8 weeks in closed boxes
Hamilton Depression Rating Scale in the questionnaire form was completed by the clinician to assess the degree of depression and clinical status of the participants Then the remaining parts of the questionnaire were directed to the patients Anthropometric measurements were performed after completion of the questionnaire Blood samples were collected from participants at the beginning and end of the study to analyze biochemical outcomes The second interview was conducted at mid-study at the end of week 4 and the final interview was conducted at the end of week 8 In the second interview with the patients the same procedures were performed except for the collection of blood samples and the food craving scale In the last interview the protocols were the same except for product administration
Participants were prescribed a daily dose of 4 capsules 4500 mg 2 gday stored at the appropriate temperature during the 8-week treatment period Patients were informed to take 2 of the capsules in the daily oral bottle in the morning before breakfast and the other 2 capsules before dinner The capsule bottles contained 500 mg concentrated krill oil fish oil or placebo capsules The daily intake of EPADHA from krill and fish oil was determined as 520 mg and 600 mg respectively
Data Collection
Data of the participants were collected at the beginning middle and end of the study three times in total by face-to-face interview with a questionnaire form The questionnaire included sociodemographic characteristics health information lifestyle Hamilton Depression Rating Scale Depression-Anxiety-Stress Scale Food Cravings Scale anthropometric measurements and one-day food consumption record
Statistical Analysis
Statistical Package for Social Sciences SPSS and R studio software program were used for statistical analysis of the data The mean and standard deviation values were given for continuous data that met the normal distribution condition otherwise the median and quartiles 25th and 75th quartile values were given Categorical data were presented as frequency and percentage One-way ANOVA test was used to compare continuous variables that met the normal distribution condition between the groups and Kruskal-Wallis H test was used for those that did not meet the normal distribution condition Pearson chi-square test was used to compare categorical data Repeated measures ANOVA General linear model test was used in the comparison of more than two dependent variables if they met the normal distribution condition To evaluate the differences between groups p time p group and p grouptime interaction effect were shown The p time value expresses the comparison of any numerical variable in the group between times The p timegroups value expresses the comparison of the numerical variable between the groups depending on time In other words it gives information about whether the study groups have superiority over each other during the intervention period on any variable In addition partial eta square values are presented for the effect size of the interaction effect of group and time A partial eta squared value of 006 indicates a small effect size a value between 006-014 indicates a medium effect size and a value 014 indicates a large effect size In addition the standardized mean differences standard error 95 confidence interval and p-values of the participants depression anxiety and stress scores within each group were presented Bonferroni correction was used to calculate the p-value If the normal distribution condition was not met Friedman test was used and if p005 Wilcoxon test was performed in paired groups and Bonferroni correction was used to calculate the p value In addition after the classification of depression anxiety and stress within the groups the Stuart-Maxwell test R studio was used to test the statistical significance of the changes in the severity of the disease before and after the intervention The results were evaluated at 95 confidence intervals and a pairwise p005 was considered statistically significant
References
1 Bromet E et al Cross-national epidemiology of DSM-IV major depressive episode BMC medicine 2011 9 p 1-16
2 Rush AJ et al Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps a STAR D report Focus 2008 61 p 128-142
3 Thase ME et al Cognitive Therapy Versus Medication in Augmentation and Switch Strategies as Second-Step Treatments A STAR D Report Focus 2008 61 p 104-119
4 Organization WH Depression Fact sheet No 369October 2012 2015
5 Rangel-Huerta OD and A Gil Omega 3 fatty acids in cardiovascular disease risk factors An updated systematic review of randomised clinical trials Clinical nutrition 2018 371 p 72-77
6 Buoite Stella A et al Update on the impact of omega 3 fatty acids on inflammation insulin resistance and sarcopenia a review International journal of molecular sciences 2018 191 p 218
7 Crupi R A Marino and S Cuzzocrea n-3 fatty acids role in neurogenesis and neuroplasticity Current medicinal chemistry 2013 2024 p 2953-2963
8 Appleton KM et al Omega-3 fatty acids for depression in adults Cochrane Database of Systematic Reviews 202111
9 Burri L Krill oil supplementation and cognitive function in Diet and Nutrition in Dementia and Cognitive Decline 2015 Elsevier p 1031-1038
10 Colletti A et al Advances in technologies for highly active omega-3 fatty acids from krill oil Clinical applications Marine Drugs 2021 196 p 306
11 Adıgüzel KT K Işgın and G Pekcan Krill yağı desteği ve yeni bilimsel kanıtlar Beslenme ve Diyet Dergisi 2015 433 p 258-263
12 Di Marzo V et al Dietary krill oil increases docosahexaenoic acid and reduces 2-arachidonoylglycerol but not N-acylethanolamine levels in the brain of obese Zucker rats International dairy journal 2010 204 p 231-235
13 Konagai C et al Effects of krill oil containing n-3 polyunsaturated fatty acids in phospholipid form on human brain function a randomized controlled trial in healthy elderly volunteers Clinical interventions in aging 2013 p 1247-1257
14 Zadeh-Ardabili PM et al Antidepressant-like effects of fish krill oils and Vit B12 against exposure to stress environment in mice models current status and pilot study Scientific reports 2019 91 p 19953
15 Wurtman RJ and JJ Wurtman Brain serotonin carbohydrate-craving obesity and depression Obesity research 1995 3S4 p 477S-480S
16 Paans NP et al Depression and eating styles are independently associated with dietary intake Appetite 2019 134 p 103-110
17 Lopresti AL SD Hood and PD Drummond A review of lifestyle factors that contribute to important pathways associated with major depression diet sleep and exercise Journal of affective disorders 2013 1481 p 12-27
18 SM S Stahlın temel psikofarmakolojisi nörobilimsel ve pratik uygulamalar Cambridge University Press T Uzbay çev ed 2012 3 p 535-6
19 Blaine B Does depression cause obesity A meta-analysis of longitudinal studies of depression and weight control Journal of health psychology 2008 138 p 1190-1197
20 Luppino FS et al Overweight obesity and depression a systematic review and meta-analysis of longitudinal studies Archives of general psychiatry 2010 673 p 220-229
21 Lespérance F et al The efficacy of omega-3 supplementation for major depression a randomized controlled trial Journal of Clinical Psychiatry 2011 728 p 1054
Major Depressive Disorder MDD affects approximately 6 of the adult population worldwide each year and is the second greatest contributor to the burden of chronic disease In the treatment of MDD both psychotherapy and psychopharmacology are effective However approximately 30 of patients do not achieve definitive recovery even after several treatment attempts Major depressive disorder can affect an individuals life as a whole and is difficult to treat due to its high rate of relapse and it is often associated with anxiety and cardiovascular diseases CVD which can threaten an individuals life It is estimated that major depression is responsible for 3 of the global burden of disease according to the World Health Organization WHO report and that this rate may increase to 7 by 2030 Therefore alternatives to effective treatments and prevention strategies are urgently needed due to this increasing trend
Omega-3 polyunsaturated fatty acids n-3 PUFAs identified with fish oil became one of the most researched nutritional topics on the effects of major depressive disorder Omega-3 polyunsaturated fatty acids are shown to be effective in cardiovascular disease CVD prevention due to their anti-inflammatory and cardio-protective effects It can potentially share common mechanisms with CVD considering factors such as increased production of pro-inflammatory cytokines endothelial dysfunction and increases in plasma homocysteine levels which play a role in the pathophysiology of some psychiatric disorders such as depression It is possible that omega-3 has multiple positive effects on depression through its neurogenesis and neuroplasticity abilities as well as having a positive effect on pathophysiological mechanisms Appleton et al conducted a Cochrane review to investigate the effect of n-3 PUFA supplements on depression in adults This review included 25 studies total 1438 participants investigating the effect of n-3 PUFA supplements versus placebo and 1 study 40 participants comparing n-3 PUFA supplements with antidepressant treatment As a result it was reported that n-3 PUFA supplements had a modestly positive effect on depression compared to placebo However it was emphasized in this report that the majority of the studies 22 studies had a low level of evidence This was attributed to factors such as high levels of bias duration of follow-up methodological errors and deficiencies due to blinded designs The general conclusion of the authors was that there was a need for high quality intervention studies in this field
Although there are a large number of studies focusing on the use of fish oil in depression research using krill oil another source rich in n-3 PUFAs is very limited Krill oil is an important shellfish that lives in the oceans around the Antarctic continent and attracts attention in research due to its rich omega-3 fatty acid content As krill is a species living in cold regions they are rich in EPA and DHA content along with PUFAs in the form of phospholipids and especially phosphatidylcholine in cell membrane structures The form containing and binding Docosahexaenoic acid DHA and Eicosapentaenoic acid EPA in krill oil is phospholipids contrary to triglyceride in fish oil Therefore the absorption and bioavailability activities are different because of the difference in the forms in fish and krill oil Although there are studies on the effects of krill oil on the nervous system on the human research there is limited research on the effectiveness of krill oil on depression To our knowledge there was only one pilot study on rats comparing the treatment efficacy of fish and krill oil on depression This study compared the antidepressant effects of krill EPA 60 mg500 mg DHA 35 mg500 mg and fish oil EPA 90 mg500 mg DHA 60 mg500 mg vitamin B12 and imipramine As a result krill oil showed favorable results on a number of variables compared to fish oil but similar results were found in both groups It is important to compare the efficacy of krill and fish oil with similar EPA and DHA content on depression to clarify the question of which of these oils in different forms may be more effective on the disease
Major depressive disorders affect many mechanisms such as food intake taste perception and food selection When clinical pictures related to the nutritional status of depressed individuals are examined changes in appetite increased consumption of certain food groups and related changes in body weight are frequently observed In addition antidepressant drugs used may also affect food intake and weight control Eating behavior is under the control of complex neural mechanisms especially serotonin At the same time food intake is also effective in the control of serotonin release in serotonergic neurons Serotonin which has a bidirectional relationship with eating behavior is a neurotransmitter involved in the physiopathology of many psychiatric disorders The presence of a disorder in the serotonin pathway may explain the development of both psychiatric disorders and obesity in the patient As a result it was reported that eating behavior disorders interest in unhealthy food consumption and increased appetite in major depressives as in some psychiatric disorders may lead to an increase in body weight in individuals during the illness or in progressive processes There are several studies examining the relationship between depression and obesity However clinical studies to determine the factors leading to this condition are limited In addition data collection on eating behavior appetite and weight status is neglected in most clinical interventions in patients with depression Therefore it is important to investigate the efficacy of n-3 fatty acids on appetite and body composition as well as eating behaviors that examine food cravings in depressed individuals
Considering all of these opinions this study aimed to determine the effectiveness of krill and fish oil on clinical effects biochemical findings and eating behavior in individuals diagnosed with MDD and to compare the results with the control group
METHODS
This study was designed with a randomized double-blind placebo-controlled The study was conducted in the Psychiatry Clinic of Adıyaman University Training and Research Hospital with 50 patients over the age of 18 diagnosed with MDD The duration of the intervention for each participant was 8 weeks The included patients received fish oil or krill oil or placebo The study was conducted in accordance with good clinical guidelines and in accordance with the Declaration of Helsinki Ethical approval was also obtained from the Ethics Committee of Fırat University
Participants
The study was enrolled with 66 patients with MDD who were over 18 years of age and fulfilled the inclusion criteria Inclusion criteria were 1 being diagnosed with major depression by a psychiatrist in accordance with DSM V diagnostic criteria 2 not taking antidepressant medication or being on antidepressant medication for the last 1 month without medication change 3 signing the informed consent form The exclusion criteria were as follows 1 those who used more than two antidepressants 2 substance users in the last 6 months 3 alcohol dependence 4 suicidal ideation and suicidal tendencies followed up by clinicians 5 presence of other psychiatric disorders such as comorbid psychosis schizophrenia and bipolar excluding dysthymia and anxiety 6 Presence of serious chronic diseases 7 pregnant or lactating women 8 Medication users that may cause emotional symptoms EscitolopromLexopro etc 9 food allergies 10 individuals at high risk of bleeding or those taking anti-coagulant drugs such as warfarin 11 Consumers of 3 or more servings of fish per week 12 Using any nutritional supplement 13 Hypercholesterolemia or taking medication for hypercholesterolemia 14 those who did not sign the informed consent form
Sample Size and Randomization and Blinded
The sample size was determined based on the findings of a similar study using the G power 3197 software program with an effect size of 0224 95 confidence interval and a margin of error of 005
This study was a randomized controlled double-blind study design The assignment of patients to groups randomization was performed by a statistician who was not involved in the research and was concealed from the patients At the first stage stratified randomization was performed to ensure homogeneous distribution of patients according to age and gender and then simple randomization was performed from each layer to ensure equal assignment to all groups Each patient was assigned a number between 1-60 and then stratified according to gender male and female and age group 18-34 and 35-64 years In the last stage numbers were generated with the R studio statistical program to assign an equal number of patients to each group
The statistician randomly assigned the color codes on the capsule bottles to each group and each group received the test products from the researcher in a closed package according to the color codes These color codes were not known by the researchers and patients until the endpoint of the study In addition the researcher clinician and participant were blinded until the study was reported
Intervention
The researcher conducted three 45-minute interviews with the participants for 8 weeks at the beginning mid and end of the study In the first interview patients were given the product they should receive for 8 weeks in closed boxes
Hamilton Depression Rating Scale in the questionnaire form was completed by the clinician to assess the degree of depression and clinical status of the participants Then the remaining parts of the questionnaire were directed to the patients Anthropometric measurements were performed after completion of the questionnaire Blood samples were collected from participants at the beginning and end of the study to analyze biochemical outcomes The second interview was conducted at mid-study at the end of week 4 and the final interview was conducted at the end of week 8 In the second interview with the patients the same procedures were performed except for the collection of blood samples and the food craving scale In the last interview the protocols were the same except for product administration
Participants were prescribed a daily dose of 4 capsules 4500 mg 2 gday stored at the appropriate temperature during the 8-week treatment period Patients were informed to take 2 of the capsules in the daily oral bottle in the morning before breakfast and the other 2 capsules before dinner The capsule bottles contained 500 mg concentrated krill oil fish oil or placebo capsules The daily intake of EPADHA from krill and fish oil was determined as 520 mg and 600 mg respectively
Data Collection
Data of the participants were collected at the beginning middle and end of the study three times in total by face-to-face interview with a questionnaire form The questionnaire included sociodemographic characteristics health information lifestyle Hamilton Depression Rating Scale Depression-Anxiety-Stress Scale Food Cravings Scale anthropometric measurements and one-day food consumption record
Statistical Analysis
Statistical Package for Social Sciences SPSS and R studio software program were used for statistical analysis of the data The mean and standard deviation values were given for continuous data that met the normal distribution condition otherwise the median and quartiles 25th and 75th quartile values were given Categorical data were presented as frequency and percentage One-way ANOVA test was used to compare continuous variables that met the normal distribution condition between the groups and Kruskal-Wallis H test was used for those that did not meet the normal distribution condition Pearson chi-square test was used to compare categorical data Repeated measures ANOVA General linear model test was used in the comparison of more than two dependent variables if they met the normal distribution condition To evaluate the differences between groups p time p group and p grouptime interaction effect were shown The p time value expresses the comparison of any numerical variable in the group between times The p timegroups value expresses the comparison of the numerical variable between the groups depending on time In other words it gives information about whether the study groups have superiority over each other during the intervention period on any variable In addition partial eta square values are presented for the effect size of the interaction effect of group and time A partial eta squared value of 006 indicates a small effect size a value between 006-014 indicates a medium effect size and a value 014 indicates a large effect size In addition the standardized mean differences standard error 95 confidence interval and p-values of the participants depression anxiety and stress scores within each group were presented Bonferroni correction was used to calculate the p-value If the normal distribution condition was not met Friedman test was used and if p005 Wilcoxon test was performed in paired groups and Bonferroni correction was used to calculate the p value In addition after the classification of depression anxiety and stress within the groups the Stuart-Maxwell test R studio was used to test the statistical significance of the changes in the severity of the disease before and after the intervention The results were evaluated at 95 confidence intervals and a pairwise p005 was considered statistically significant
References
1 Bromet E et al Cross-national epidemiology of DSM-IV major depressive episode BMC medicine 2011 9 p 1-16
2 Rush AJ et al Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps a STAR D report Focus 2008 61 p 128-142
3 Thase ME et al Cognitive Therapy Versus Medication in Augmentation and Switch Strategies as Second-Step Treatments A STAR D Report Focus 2008 61 p 104-119
4 Organization WH Depression Fact sheet No 369October 2012 2015
5 Rangel-Huerta OD and A Gil Omega 3 fatty acids in cardiovascular disease risk factors An updated systematic review of randomised clinical trials Clinical nutrition 2018 371 p 72-77
6 Buoite Stella A et al Update on the impact of omega 3 fatty acids on inflammation insulin resistance and sarcopenia a review International journal of molecular sciences 2018 191 p 218
7 Crupi R A Marino and S Cuzzocrea n-3 fatty acids role in neurogenesis and neuroplasticity Current medicinal chemistry 2013 2024 p 2953-2963
8 Appleton KM et al Omega-3 fatty acids for depression in adults Cochrane Database of Systematic Reviews 202111
9 Burri L Krill oil supplementation and cognitive function in Diet and Nutrition in Dementia and Cognitive Decline 2015 Elsevier p 1031-1038
10 Colletti A et al Advances in technologies for highly active omega-3 fatty acids from krill oil Clinical applications Marine Drugs 2021 196 p 306
11 Adıgüzel KT K Işgın and G Pekcan Krill yağı desteği ve yeni bilimsel kanıtlar Beslenme ve Diyet Dergisi 2015 433 p 258-263
12 Di Marzo V et al Dietary krill oil increases docosahexaenoic acid and reduces 2-arachidonoylglycerol but not N-acylethanolamine levels in the brain of obese Zucker rats International dairy journal 2010 204 p 231-235
13 Konagai C et al Effects of krill oil containing n-3 polyunsaturated fatty acids in phospholipid form on human brain function a randomized controlled trial in healthy elderly volunteers Clinical interventions in aging 2013 p 1247-1257
14 Zadeh-Ardabili PM et al Antidepressant-like effects of fish krill oils and Vit B12 against exposure to stress environment in mice models current status and pilot study Scientific reports 2019 91 p 19953
15 Wurtman RJ and JJ Wurtman Brain serotonin carbohydrate-craving obesity and depression Obesity research 1995 3S4 p 477S-480S
16 Paans NP et al Depression and eating styles are independently associated with dietary intake Appetite 2019 134 p 103-110
17 Lopresti AL SD Hood and PD Drummond A review of lifestyle factors that contribute to important pathways associated with major depression diet sleep and exercise Journal of affective disorders 2013 1481 p 12-27
18 SM S Stahlın temel psikofarmakolojisi nörobilimsel ve pratik uygulamalar Cambridge University Press T Uzbay çev ed 2012 3 p 535-6
19 Blaine B Does depression cause obesity A meta-analysis of longitudinal studies of depression and weight control Journal of health psychology 2008 138 p 1190-1197
20 Luppino FS et al Overweight obesity and depression a systematic review and meta-analysis of longitudinal studies Archives of general psychiatry 2010 673 p 220-229
21 Lespérance F et al The efficacy of omega-3 supplementation for major depression a randomized controlled trial Journal of Clinical Psychiatry 2011 728 p 1054
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None