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Intermittent Fasting (IF) Has Gained Recognition as a Promising Weight Loss Approach That Improves Body Weight, Insulin Resistance, and Metabolism. While Standard Diets Are Common in PCOS Management, IF May Address the Underlying Causes of Weight Gain and Offer Additional Metabolic Benefits

NCT ID: NCT06804044

Last Updated: 2025-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-01-24

Brief Summary

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The goal of this clinical trial is to learn if dietary interventions works to improve anthropometric measures in women with PCOS. The main questions it aims to answer are:

* Does intermittent fasting (IF) cause loss of body weight, fat and muscle mass?
* Can IF be considered more effective to medical and standart nutrition therapy (SDT)?
* What dietary problems do participants have when having IF diet?

Participants will:

* Follow IF, SDT, or no intervention for 8 weeks.
* Visit the clinic once every 2 weeks for check ups with a total of 5 visits for intervention groups IF and STD, visit at the beginning, second week and at the end for control group
* Keep dietary records

Detailed Description

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It was conducted in individuals who were diagnosed with PCOS as a result of clinical, biochemical and ultrasonographic medical evaluation by a gynecologist.

Conditions

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Polycystic Ovary Syndrome Weight Loss Intermittent Fasting Medical Nutrition Therapy Caloric Restriction

Keywords

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Diet PCOS IF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent Fasting Diet Therapy

The dietary principles implemented for overweight/obese women with PCOS: targeting a 5% weight loss in line with the recommendations of the Turkish Endocrinology and Metabolism Association, calculating daily calorie requirements using the Harris-Benedict formula, and setting macronutrient distribution ratios to 45-60% carbohydrates, 15-20% protein, and 25-30% fat.

Group Type EXPERIMENTAL

Intermittent Fasting

Intervention Type BEHAVIORAL

A 16:8 intermittent fasting with a daytime eating window model was applied.

Standart Diet Therapy

The dietary principles implemented for overweight/obese women with PCOS: targeting a 5% weight loss in line with the recommendations of the Turkish Endocrinology and Metabolism Association, calculating daily calorie requirements using the Harris-Benedict formula, and setting macronutrient distribution ratios to 45-60% carbohydrates, 15-20% protein, and 25-30% fat.

Group Type EXPERIMENTAL

Standart Diet Therapy

Intervention Type BEHAVIORAL

Meal plan with 3 main meals and 3 snacks was applied.

Free of dietary intervention

No dietary intervention was made and the individuals continued their current diet.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intermittent Fasting

A 16:8 intermittent fasting with a daytime eating window model was applied.

Intervention Type BEHAVIORAL

Standart Diet Therapy

Meal plan with 3 main meals and 3 snacks was applied.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Voluntariness to participate in the study
* BMI between 25-35 kg/m2
* Women between the ages of 18-45

Exclusion Criteria

* An endocrine disorder other than polycystic ovary syndrome
* Chronic liver and kidney disease,
* Diabetes,
* Hypertension,
* Hyperuricemia,
* Heart Failure,
* Thyroid disease,
* Pregnant and breastfeeding women,
* Individuals with psychiatric disorders,
* Oncological diseases,
* Women using medication,
* Those with pacemakers and platinum,
* Those with special nutritional needs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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Yonca Sevim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bahçeşehir University

Istanbul, Beşiktaş, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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12309112022

Identifier Type: -

Identifier Source: org_study_id