Short Term Ketogenic Diet in Polycictic Ovary Syndrome

June 19, 2024 updated by: Hande Seven Avuk, Istanbul Bilgi University

Effects of Short-Term Low-Calorie Ketogenic Diet on Biochemical and Anthropometric Parameters in Women With Polycystic Ovary Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was conducted on patients who applied to a nutrition and diet consultancy center in İstanbul.All 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: 1.737 and SD: 2.1 for the change parameter observed in the BMI level, and with a 95% confidence interval,1-β: 0.95 and α: 0.05 were determined as at least 7 individuals in the G*Power 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 changes.During 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 completed.This 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 (1.4), and thermal energy of food (10%). Mifflin-St. Joer's 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 g/day and protein of 0.8-1.2 g/kg/day. 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 g/day, 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 İstanbul.All 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: 1.737 and SD: 2.1 for the change parameter observed in the BMI level, and with a 95% confidence interval,1-β: 0.95 and α: 0.05 were determined as at least 7 individuals in the G*Power 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 changes.During 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 completed.This 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 (1.4), and thermal energy of food (10%). Mifflin-St. Joer's 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 g/day and protein of 0.8-1.2 g/kg/day. 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 g/day, 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 Measurements:This 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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34060
        • Istanbul Bilgi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female individuals who were diagnosed with PCOS according to the Rotterdam 2003 criteria,
  • Individuals suitable for LCKD

Exclusion Criteria:

  • Endocrine disorders other than PCOS,
  • Chronic liver disease,
  • Chronic kidney disease,
  • Hypertension,
  • Hyperuricemia,
  • Heart failure, infarction or cerebrovascular disease,
  • Pregnant and breastfeeding women,
  • Severe psychiatric disorders,
  • Oncological diseases,
  • Individuals using medications that may affect biochemical parameters,
  • Individuals with special dietary needs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic Diet Intervention
4 weeks low calorie Ketogenic Diet intervention
Other: Diet Treatment
4 weeks low calorie diet treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric Measurements - Body weight and composition
Time Frame: 4 weeks (Between two menstrual cycle)
Body weight (kg) of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards (Norton, 2018). Total body weight and body composition analysis (fat ratio, fat, muscle, fluid mass, and phase angle [PhA]) were performed following the protocol using the TANİTA MC780 MA bio-electrical impedance device with a sensitivity of 50 grams.
4 weeks (Between two menstrual cycle)
Anthropometric Measurements - Height
Time Frame: 4 weeks (Between two menstrual cycle)
Height (cm) measurements of the participants were measured following anthropometric measurement standards with stadiometer (Norton, 2018).
4 weeks (Between two menstrual cycle)
Anthropometric Measurements - Circumferences
Time Frame: 4 weeks (Between two menstrual cycle)
Waist, hip, neck, upper middle arm, and chest circumference measurements of the participants were measured in light clothing on an empty stomach, following anthropometric measurement standards (Norton, 2018).
4 weeks (Between two menstrual cycle)
Body Mass Index
Time Frame: 4 weeks (Between two menstrual cycle)
Body mass index (BMI) (kg/m2) was calculated using the following equation: body weight (kg)/height (m2) (Misra & Dhurandhar, 2019).
4 weeks (Between two menstrual cycle)
Biochemical Measurements
Time Frame: 4 weeks (Between two menstrual cycle)
This 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. It is calculated using the following formula: HOMA-IR = (fasting glucose [mg/dL] × fasting insulin [uIU/mL])/405 (Matthews et al., 1985).
4 weeks (Between two menstrual cycle)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Consumption Evaluation
Time Frame: 1 times before intervention
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). Intakes of macro- and micronutrients such as energy, carbohydrates, proteins, and fats were evaluated using the Nutrition Information System (BeBİS) 8.2 full version program (BeBİS, 2019).
1 times before intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Bilgi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDPCOS
  • 2019-14/17 (Registry Identifier: Acıbadem Mehmet Ali Aydınlar University on Medical Research Evaluation Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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