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

NCT06804044 | Completed

• 1 other identifier: 12309112022
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Diet; PCOS; IF

Outcome Measures

Primary Outcomes (3)

• Body Weight lose

  Total body weight (kg)

  8 weeks

• Body Composition: Fat, Muscle

  Body Muscle= skeletal muscle mass (kg), regional muscle analysis (right-left arm, trunk, right-left leg) (kg). Body Fat= fat mass (kg), regional fat analysis (right-left arm, trunk, right-left leg) (kg).

  8 weeks

• Body Circumference Measurements

  Waist Circumference, Hip Circumference, Upper Arm Circumference, Neck Circumference

  8 weeks

Secondary Outcomes (7)

• Body Mass Indeks

  8 weeks

• Body Fat Ratio

  8 weeks

• Body Water

  8 weeks

• Dietary Energy Intakes

  8 weeks

• Energy Ratio from Macronutrients

  8 weeks

Study Arms (3)

Intermittent Fasting Diet Therapy

EXPERIMENTAL

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.

Behavioral: Intermittent Fasting

Standart Diet Therapy

EXPERIMENTAL

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.

Behavioral: Standart Diet Therapy

Free of dietary intervention

NO INTERVENTION

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

Interventions

Intermittent Fasting BEHAVIORAL

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

Intermittent Fasting Diet Therapy

Standart Diet Therapy BEHAVIORAL

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

Standart Diet Therapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahçeşehir University

Istanbul, Beşiktaş, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Weight Loss; Intermittent Fasting

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 31, 2025
• Study Start: November 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: January 24, 2024
• Last Updated: January 31, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)