Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469255
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-03-12
Brief Title:
Short Term Ketogenic Diet in Polycictic Ovary Syndrome
Sponsor:
Istanbul Bilgi University
Organization:
Istanbul Bilgi University
Study Overview
Official Title:
Effects of Short-Term Low-Calorie Ketogenic Diet on Biochemical and Anthropometric Parameters in Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Polycystic ovary syndrome PCOS is one of the most common health problems in women of reproductive age characterized by increased androgen levels impaired ovulatory functions and polycystic ovaries In addition to cosmetic problems including hirsutism and acne it also poses a risk for significant chronic diseases including infertility dyslipidemia obesity sleep apnea diabetes cardiovascular diseases and various malignancies
The aim of this clinical study was to investigate the effects of short-term low-calorie ketogenic diet LCKD intervention on anthropometric biochemical and hormonal parameters in women with PCOS The main questions it aims to answer are
Is a short-term low-calorie ketogenic diet effective on body composition in overweight women with PCOS
Is a short-term low-calorie ketogenic diet effective on biochemical and hormonal parameters in overweight women with PCOS
Participants were diagnosed with PCOS according to the Rotterdam 2003 criteria as a result of the clinical biochemical and ultrasonographic medical evaluation made by the gynecologist and those who were found to be eligible for LCKD and volunteered to participate in the study were included in the study
Researchers are examining whether a low-calorie ketogenic diet applied between two menstrual cycles has any effects on anthropometric biochemical and hormonal parameters in women with PCOS
The aim of this clinical study was to investigate the effects of short-term low-calorie ketogenic diet LCKD intervention on anthropometric biochemical and hormonal parameters in women with PCOS The main questions it aims to answer are
Is a short-term low-calorie ketogenic diet effective on body composition in overweight women with PCOS
Is a short-term low-calorie ketogenic diet effective on biochemical and hormonal parameters in overweight women with PCOS
Participants were diagnosed with PCOS according to the Rotterdam 2003 criteria as a result of the clinical biochemical and ultrasonographic medical evaluation made by the gynecologist and those who were found to be eligible for LCKD and volunteered to participate in the study were included in the study
Researchers are examining whether a low-calorie ketogenic diet applied between two menstrual cycles has any effects on anthropometric biochemical and hormonal parameters in women with PCOS
Detailed Description:
This study was conducted on patients who applied to a nutrition and diet consultancy center in İstanbulAll patients provided written informed consent before the start of the study and after receiving a detailed explanation of the procedures The sample size of this study was that of Paoli et al 19 according to the reference study were taken as d 1737 and SD 21 for the change parameter observed in the BMI level and with a 95 confidence interval1-β 095 and α 005 were determined as at least 7 individuals in the GPower program
Exclusion Criteria Those with any endocrine disorders other than PCOS chronic liver or kidney disease hypertension hyperuricemia heart failure infarction or cerebrovascular disease pregnant and breastfeeding women those with severe psychiatric disorders oncological diseases those using medications that may affect biochemical parameters and individuals with special dietary needs were excluded in this study
General Plan of the Study During the study four follow-up interviews were held at 7-10-day intervals to monitor participants diet compliance and body composition changesDuring the first meeting information was provided verbally and in writing regarding the purpose and scope of the study and an informed consent form was signed The second interview was held on the second or third day of menstruation During this meeting blood was taken from the individuals to analyze biochemical parameters and then their anthropometric measurements were taken and LCKD was given Additionally to determine whether LCKD was not applied before the intervention a urine ketone test was performed wherein urine samples were examined for the presence of ketones During the third interview urine ketone test was performed to evaluate participants compliance with the diet and body composition changes were monitored During the study to track their food consumption participants shared photos of the meals they consumed with the researcher The fourth and final interview was conducted on the second or third day of the first menstrual period after the LCKD intervention started The presence of ketosis was determined by examining the urine ketone level again Subsequently blood was taken for basal hormone and biochemical measurements anthropometric measurements were evaluated for the last time and the LCKD intervention was completedThis intervention study was conducted between two menstrual cycles
Planning a Ketogenic Diet Intervention A personalized LCKD was planned Daily energy requirement is the sum of basal metabolic rate physical activity factor 14 and thermal energy of food 10 Mifflin-St Joers equation was used to determine the basal metabolic rate Total daily energy requirement was reduced by 500 calories Castellana et al suggested that the macronutrient content of the LCKD was calculated as carbohydrates of 20 gday and protein of 08-12 gkgday It is calculated according to the individuals carbohydrate and protein needs with the remainder of the total energy coming from fat Daily fat consumption is 30-40 gday as in typical LCKDs Castellana et al 2020 Participants were allowed to eat unlimited green leafy vegetables cruciferous vegetables squash and cucumbers during the intervention
This study was conducted on patients who applied to a nutrition and diet consultancy center in İstanbulAll patients provided written informed consent before the start of the study and after receiving a detailed explanation of the procedures The sample size of this study was that of Paoli et al 19 according to the reference study were taken as d 1737 and SD 21 for the change parameter observed in the BMI level and with a 95 confidence interval1-β 095 and α 005 were determined as at least 7 individuals in the GPower program
Exclusion Criteria Those with any endocrine disorders other than PCOS chronic liver or kidney disease hypertension hyperuricemia heart failure infarction or cerebrovascular disease pregnant and breastfeeding women those with severe psychiatric disorders oncological diseases those using medications that may affect biochemical parameters and individuals with special dietary needs were excluded in this study
General Plan of the Study During the study four follow-up interviews were held at 7-10-day intervals to monitor participants diet compliance and body composition changesDuring the first meeting information was provided verbally and in writing regarding the purpose and scope of the study and an informed consent form was signed The second interview was held on the second or third day of menstruation During this meeting blood was taken from the individuals to analyze biochemical parameters and then their anthropometric measurements were taken and LCKD was given Additionally to determine whether LCKD was not applied before the intervention a urine ketone test was performed wherein urine samples were examined for the presence of ketones During the third interview urine ketone test was performed to evaluate participants compliance with the diet and body composition changes were monitored During the study to track their food consumption participants shared photos of the meals they consumed with the researcher The fourth and final interview was conducted on the second or third day of the first menstrual period after the LCKD intervention started The presence of ketosis was determined by examining the urine ketone level again Subsequently blood was taken for basal hormone and biochemical measurements anthropometric measurements were evaluated for the last time and the LCKD intervention was completedThis intervention study was conducted between two menstrual cycles
Planning a Ketogenic Diet Intervention A personalized LCKD was planned Daily energy requirement is the sum of basal metabolic rate physical activity factor 14 and thermal energy of food 10 Mifflin-St Joers equation was used to determine the basal metabolic rate Total daily energy requirement was reduced by 500 calories Castellana et al suggested that the macronutrient content of the LCKD was calculated as carbohydrates of 20 gday and protein of 08-12 gkgday It is calculated according to the individuals carbohydrate and protein needs with the remainder of the total energy coming from fat Daily fat consumption is 30-40 gday as in typical LCKDs Castellana et al 2020 Participants were allowed to eat unlimited green leafy vegetables cruciferous vegetables squash and cucumbers during the intervention
Food Consumption Evaluation Participants food consumption before the dietary intervention was recorded using the 24-h reminder method 2 days on weekdays and 1 day on the weekend
Biochemical MeasurementsThis study was conducted between two menstrual cycles to accurately determine baseline and ending basal hormone levels and biochemical parameters were measured by blood collection on the second to third day of menstruation On the following days a nurse extracted blood samples following an 8-12-h fasting Subsequently the blood samples were examined for fasting insulin fasting blood glucose total cholesterol triglyceride HDL-cholesterol LDL-cholesterol DHEA-SO4 androstenedione LH FSH estradiol SHBG total testosterone prolactin IGF-1 and TNF-α levels HOMA-IR which was developed by Mathews et al was used to determine insulin resistance using fasting glucose and insulin levels
Exclusion Criteria Those with any endocrine disorders other than PCOS chronic liver or kidney disease hypertension hyperuricemia heart failure infarction or cerebrovascular disease pregnant and breastfeeding women those with severe psychiatric disorders oncological diseases those using medications that may affect biochemical parameters and individuals with special dietary needs were excluded in this study
General Plan of the Study During the study four follow-up interviews were held at 7-10-day intervals to monitor participants diet compliance and body composition changesDuring the first meeting information was provided verbally and in writing regarding the purpose and scope of the study and an informed consent form was signed The second interview was held on the second or third day of menstruation During this meeting blood was taken from the individuals to analyze biochemical parameters and then their anthropometric measurements were taken and LCKD was given Additionally to determine whether LCKD was not applied before the intervention a urine ketone test was performed wherein urine samples were examined for the presence of ketones During the third interview urine ketone test was performed to evaluate participants compliance with the diet and body composition changes were monitored During the study to track their food consumption participants shared photos of the meals they consumed with the researcher The fourth and final interview was conducted on the second or third day of the first menstrual period after the LCKD intervention started The presence of ketosis was determined by examining the urine ketone level again Subsequently blood was taken for basal hormone and biochemical measurements anthropometric measurements were evaluated for the last time and the LCKD intervention was completedThis intervention study was conducted between two menstrual cycles
Planning a Ketogenic Diet Intervention A personalized LCKD was planned Daily energy requirement is the sum of basal metabolic rate physical activity factor 14 and thermal energy of food 10 Mifflin-St Joers equation was used to determine the basal metabolic rate Total daily energy requirement was reduced by 500 calories Castellana et al suggested that the macronutrient content of the LCKD was calculated as carbohydrates of 20 gday and protein of 08-12 gkgday It is calculated according to the individuals carbohydrate and protein needs with the remainder of the total energy coming from fat Daily fat consumption is 30-40 gday as in typical LCKDs Castellana et al 2020 Participants were allowed to eat unlimited green leafy vegetables cruciferous vegetables squash and cucumbers during the intervention
This study was conducted on patients who applied to a nutrition and diet consultancy center in İstanbulAll patients provided written informed consent before the start of the study and after receiving a detailed explanation of the procedures The sample size of this study was that of Paoli et al 19 according to the reference study were taken as d 1737 and SD 21 for the change parameter observed in the BMI level and with a 95 confidence interval1-β 095 and α 005 were determined as at least 7 individuals in the GPower program
Exclusion Criteria Those with any endocrine disorders other than PCOS chronic liver or kidney disease hypertension hyperuricemia heart failure infarction or cerebrovascular disease pregnant and breastfeeding women those with severe psychiatric disorders oncological diseases those using medications that may affect biochemical parameters and individuals with special dietary needs were excluded in this study
General Plan of the Study During the study four follow-up interviews were held at 7-10-day intervals to monitor participants diet compliance and body composition changesDuring the first meeting information was provided verbally and in writing regarding the purpose and scope of the study and an informed consent form was signed The second interview was held on the second or third day of menstruation During this meeting blood was taken from the individuals to analyze biochemical parameters and then their anthropometric measurements were taken and LCKD was given Additionally to determine whether LCKD was not applied before the intervention a urine ketone test was performed wherein urine samples were examined for the presence of ketones During the third interview urine ketone test was performed to evaluate participants compliance with the diet and body composition changes were monitored During the study to track their food consumption participants shared photos of the meals they consumed with the researcher The fourth and final interview was conducted on the second or third day of the first menstrual period after the LCKD intervention started The presence of ketosis was determined by examining the urine ketone level again Subsequently blood was taken for basal hormone and biochemical measurements anthropometric measurements were evaluated for the last time and the LCKD intervention was completedThis intervention study was conducted between two menstrual cycles
Planning a Ketogenic Diet Intervention A personalized LCKD was planned Daily energy requirement is the sum of basal metabolic rate physical activity factor 14 and thermal energy of food 10 Mifflin-St Joers equation was used to determine the basal metabolic rate Total daily energy requirement was reduced by 500 calories Castellana et al suggested that the macronutrient content of the LCKD was calculated as carbohydrates of 20 gday and protein of 08-12 gkgday It is calculated according to the individuals carbohydrate and protein needs with the remainder of the total energy coming from fat Daily fat consumption is 30-40 gday as in typical LCKDs Castellana et al 2020 Participants were allowed to eat unlimited green leafy vegetables cruciferous vegetables squash and cucumbers during the intervention
Food Consumption Evaluation Participants food consumption before the dietary intervention was recorded using the 24-h reminder method 2 days on weekdays and 1 day on the weekend
Biochemical MeasurementsThis study was conducted between two menstrual cycles to accurately determine baseline and ending basal hormone levels and biochemical parameters were measured by blood collection on the second to third day of menstruation On the following days a nurse extracted blood samples following an 8-12-h fasting Subsequently the blood samples were examined for fasting insulin fasting blood glucose total cholesterol triglyceride HDL-cholesterol LDL-cholesterol DHEA-SO4 androstenedione LH FSH estradiol SHBG total testosterone prolactin IGF-1 and TNF-α levels HOMA-IR which was developed by Mathews et al was used to determine insulin resistance using fasting glucose and insulin levels
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-1417 | REGISTRY | None | None |