Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05745194
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-01-25
Brief Title:
Influence of Nutrition in Depression Treatment INDEPT
Sponsor:
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Organization:
Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA
Study Overview
Official Title:
Nutritional Counselling Promoting Adherence to the Mediterranean Diet as Adjuvant in the Treatment of Major Depressive Disorder A Randomized Open Controlled Trial Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
INDEPT
Brief Summary:
The hypothesis to be tested by this study is that an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with elevated inflammation biomarkers namely C-reactive protein CRP and Interleukin 6 IL-6 diagnosed with Major Depression Disorder MDD under treatment with antidepressant medication for a period of time less than or equal to 6 months
The main aim of this study is to understand if promoting the adherence to the MedDiet as an adjuvant strategy in the treatment of MDD is effective in decreasing symptoms of depression in MDD patients with elevated levels of inflammation biomarkers
Other specific objectives of the study are
1 To assess the association between adherence to MedDiet and changes in inflammatory biomarkers
2 To assess the association between changes in inflammatory biomarkers with symptoms of MDD
3 To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD
4 To characterize the association between adherence to MedDiet and changes in health-related quality of life
5 To evaluate the economic cost-effectiveness of dietary counselling as an adjuvant treatment in MDD
The study will have a duration of 12 weeks with a randomized parallel-group open controlled trial design with two parallel groups with an allocation ratio of 11 - a intervention arm with six nutritional consultations with a registered nutritionist promoting adherence to MedDiet in addition to MDD Treatment-As-Usual TAU and b control group arm benefitting only from MDD TAU A follow up assessment will be performed at 6- and 12-months
Having into consideration an attrition of 40 percentage at the end of the intervention the minimum sample size estimated is 190 95 per arm
The main outcome of the trial changes in symptoms of depression will be evaluated using the Beck Depression Inventory Second Edition BDI-II
The main aim of this study is to understand if promoting the adherence to the MedDiet as an adjuvant strategy in the treatment of MDD is effective in decreasing symptoms of depression in MDD patients with elevated levels of inflammation biomarkers
Other specific objectives of the study are
1 To assess the association between adherence to MedDiet and changes in inflammatory biomarkers
2 To assess the association between changes in inflammatory biomarkers with symptoms of MDD
3 To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD
4 To characterize the association between adherence to MedDiet and changes in health-related quality of life
5 To evaluate the economic cost-effectiveness of dietary counselling as an adjuvant treatment in MDD
The study will have a duration of 12 weeks with a randomized parallel-group open controlled trial design with two parallel groups with an allocation ratio of 11 - a intervention arm with six nutritional consultations with a registered nutritionist promoting adherence to MedDiet in addition to MDD Treatment-As-Usual TAU and b control group arm benefitting only from MDD TAU A follow up assessment will be performed at 6- and 12-months
Having into consideration an attrition of 40 percentage at the end of the intervention the minimum sample size estimated is 190 95 per arm
The main outcome of the trial changes in symptoms of depression will be evaluated using the Beck Depression Inventory Second Edition BDI-II
Detailed Description:
To test the studys hypothesis namely if an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with MDD and elevated inflammation biomarkers the following objectives will be assessed
The main objective of the trial is
1To assess the effectiveness of dietary counselling promoting MedDiet as an adjuvant treatment of MDD to decrease depressive symptoms in adults diagnosed with MDD and having elevated inflammation biomarkers CRP IL-6
Specific objectives are
1 To assess the association between adherence to MedDiet and changes in inflammatory biomarkers
2 To assess the association between changes in inflammatory biomarkers with symptoms of MDD
3 To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD
4 Characterize the association between adherence to MedDiet and changes in health-related quality of life
5 To evaluate the economic cost-effectiveness of dietary counselling as an adjuvant treatment in MDD
This study is a 12-week multicentre randomized parallel-group open controlled trial with a follow up assessment at 6- and 12-months after baseline data collection with two parallel groups with an allocation ratio of 11 - a intervention arm with six nutrition consultations with a registered nutritionist promoting adherence to MedDiet in addition to MDD treatment as usual TAU and b control group benefitting only from MDD TAU Participants will be individuals diagnosed with a first episode of MDD according to the F32 Depressive episode F320 F321 F322 classification of the Tenth Revision of the International Classification of Diseases ICD-10 under treatment with antidepressant medication for a period of time less than or equal to 6 months attending to outpatient consultations
Potential participants will be invited to enrol by their medical doctors from the participating recruitment centres The invitation will be made at regular medical appointments including primary care consultations and outpatient psychiatric consultations in one of the participant centers After signing the informed consent CRP and IL-6 levels will be tested Participants with increased inflammatory biomarkers meeting all other inclusion criteria will be randomized to a the intervention arm or b the control arm of the study in a 11 ratio using a computer-generated list of random numbers stratified by center in variable blocks of size 2 4 and 6 Treatment allocation will be concealed from the researchers using sequentially numbered opaque sealed envelopes
The study will use a convenience sample from patients diagnosed with MDD attending to outpatient consultations in one for the participating clinics
Considering a 2-sided significance level of 5 percent and a power of 80 percent and having into consideration an attrition of 40 percent at the end of the intervention the minimum sample size estimated is 190 95 per arm Estimating a prevalence of elevated inflammation in 30 percentage of MDD patients and 10 percentage of patients that dont meet other inclusion criteria the number of recruited participants estimated is 700
Participants allocated to the intervention group will attend six nutrition consultations performed by a register nutritionist in weeks 1 2 4 6 8 and 10 The intervention will be personalized to each participant and will promote adherence to the Mediterranean Diet ad libitum without calories or macronutrients restriction or recommendation for weight change
The intervention will follow a similar approach to the one proposed by Estruch et al in the Primary Prevention of Cardiovascular Disease with a Mediterranean Diet study
The intervention will contemplate the following recommendations
Positive recommendations promotion of the intake of the following foods
1 Use of olive oil as main fat both for cooking and dressing
2 2 or more servings of vegetables daily 200g of vegetables per serving
3 2-3 servings of fresh fruits per day
4 3 or more servings of legumes per day
5 3 or more servings of fish per week 100 - 150g of fish per serving or 200g of shellfish
6 3 or more servings of nuts a week 30g of nuts per serving
7 Meat consumption mainly from poultry without skin or rabbit
8 Home cooked meals with tomato garlic and onion at least twice a week
Negative recommendations eliminate or drastically reduce the following foods
1 Cream butter and margarine
2 Cold meats paté and duck meat
3 Carbonated andor sugared beverages
4 Pastries and industrial baked products cakes donuts or cookies
5 Industrial deserts
6 French fries and potato chips
7 Pre-cooked cakes and sweets
8 If alcohol is consumed should be limited to 300ml of wine per day 150cc at meals for men and 100cc for woman during meals
Training of the nutritionists delivering the intervention will be provided prior to the beginning of recruitment and during the duration of the trial in MDD therapeutic relationship trauma and Mediterranean Diet
Data analysis and reporting will be performed in accordance with Consolidated Standards of Reporting Trials CONSORT guidelines
Primary analysis will include all randomized participants following an intention-to-treat ITT approach Baseline characteristics of the participants by group will be reported using descriptive statistics and compared by χ2 and t-test for independent samples or equivalent non-parametric test
To evaluate the effectiveness of nutritional counselling promoting MedDiet the scale BDI-II will be used categorically in accordance with the standardized cutoffs minimal depression 0-13 mild depression 14-19 moderate depression 20-28 severe depression 29-63 The success measure will be a decrease in category in the severity of depressive symptoms The proportion of participants with a decrease in depression severity symptoms category according to the BDI-II main outcome will be compared between control and intervention groups using generalized linear mixed models
Further adjustment for relevant covariates as supportive analysis will be made Secondary analyses including the analysis of the main outcome measure BDI-II as a continuous variable will be conducted using Generalized Linear Mixed Models as appropriate For each outcome results for either intervention and control group and estimates of effect size with a 95 percent confidence interval will be reported All analyses will be performed using R and R Studio version 353 and R Studio version 13618 or another updated version in the moment of analysis assuming a significance level of 5 percent
The main objective of the trial is
1To assess the effectiveness of dietary counselling promoting MedDiet as an adjuvant treatment of MDD to decrease depressive symptoms in adults diagnosed with MDD and having elevated inflammation biomarkers CRP IL-6
Specific objectives are
1 To assess the association between adherence to MedDiet and changes in inflammatory biomarkers
2 To assess the association between changes in inflammatory biomarkers with symptoms of MDD
3 To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD
4 Characterize the association between adherence to MedDiet and changes in health-related quality of life
5 To evaluate the economic cost-effectiveness of dietary counselling as an adjuvant treatment in MDD
This study is a 12-week multicentre randomized parallel-group open controlled trial with a follow up assessment at 6- and 12-months after baseline data collection with two parallel groups with an allocation ratio of 11 - a intervention arm with six nutrition consultations with a registered nutritionist promoting adherence to MedDiet in addition to MDD treatment as usual TAU and b control group benefitting only from MDD TAU Participants will be individuals diagnosed with a first episode of MDD according to the F32 Depressive episode F320 F321 F322 classification of the Tenth Revision of the International Classification of Diseases ICD-10 under treatment with antidepressant medication for a period of time less than or equal to 6 months attending to outpatient consultations
Potential participants will be invited to enrol by their medical doctors from the participating recruitment centres The invitation will be made at regular medical appointments including primary care consultations and outpatient psychiatric consultations in one of the participant centers After signing the informed consent CRP and IL-6 levels will be tested Participants with increased inflammatory biomarkers meeting all other inclusion criteria will be randomized to a the intervention arm or b the control arm of the study in a 11 ratio using a computer-generated list of random numbers stratified by center in variable blocks of size 2 4 and 6 Treatment allocation will be concealed from the researchers using sequentially numbered opaque sealed envelopes
The study will use a convenience sample from patients diagnosed with MDD attending to outpatient consultations in one for the participating clinics
Considering a 2-sided significance level of 5 percent and a power of 80 percent and having into consideration an attrition of 40 percent at the end of the intervention the minimum sample size estimated is 190 95 per arm Estimating a prevalence of elevated inflammation in 30 percentage of MDD patients and 10 percentage of patients that dont meet other inclusion criteria the number of recruited participants estimated is 700
Participants allocated to the intervention group will attend six nutrition consultations performed by a register nutritionist in weeks 1 2 4 6 8 and 10 The intervention will be personalized to each participant and will promote adherence to the Mediterranean Diet ad libitum without calories or macronutrients restriction or recommendation for weight change
The intervention will follow a similar approach to the one proposed by Estruch et al in the Primary Prevention of Cardiovascular Disease with a Mediterranean Diet study
The intervention will contemplate the following recommendations
Positive recommendations promotion of the intake of the following foods
1 Use of olive oil as main fat both for cooking and dressing
2 2 or more servings of vegetables daily 200g of vegetables per serving
3 2-3 servings of fresh fruits per day
4 3 or more servings of legumes per day
5 3 or more servings of fish per week 100 - 150g of fish per serving or 200g of shellfish
6 3 or more servings of nuts a week 30g of nuts per serving
7 Meat consumption mainly from poultry without skin or rabbit
8 Home cooked meals with tomato garlic and onion at least twice a week
Negative recommendations eliminate or drastically reduce the following foods
1 Cream butter and margarine
2 Cold meats paté and duck meat
3 Carbonated andor sugared beverages
4 Pastries and industrial baked products cakes donuts or cookies
5 Industrial deserts
6 French fries and potato chips
7 Pre-cooked cakes and sweets
8 If alcohol is consumed should be limited to 300ml of wine per day 150cc at meals for men and 100cc for woman during meals
Training of the nutritionists delivering the intervention will be provided prior to the beginning of recruitment and during the duration of the trial in MDD therapeutic relationship trauma and Mediterranean Diet
Data analysis and reporting will be performed in accordance with Consolidated Standards of Reporting Trials CONSORT guidelines
Primary analysis will include all randomized participants following an intention-to-treat ITT approach Baseline characteristics of the participants by group will be reported using descriptive statistics and compared by χ2 and t-test for independent samples or equivalent non-parametric test
To evaluate the effectiveness of nutritional counselling promoting MedDiet the scale BDI-II will be used categorically in accordance with the standardized cutoffs minimal depression 0-13 mild depression 14-19 moderate depression 20-28 severe depression 29-63 The success measure will be a decrease in category in the severity of depressive symptoms The proportion of participants with a decrease in depression severity symptoms category according to the BDI-II main outcome will be compared between control and intervention groups using generalized linear mixed models
Further adjustment for relevant covariates as supportive analysis will be made Secondary analyses including the analysis of the main outcome measure BDI-II as a continuous variable will be conducted using Generalized Linear Mixed Models as appropriate For each outcome results for either intervention and control group and estimates of effect size with a 95 percent confidence interval will be reported All analyses will be performed using R and R Studio version 353 and R Studio version 13618 or another updated version in the moment of analysis assuming a significance level of 5 percent
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