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

Effects of Different Dietary Programs on Anthropometric Parameters in Women with Polycystic Ovary Syndrome

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Weight Loss; Intermittent Fasting; Caloric Restriction; Medical Nutrition Therapy
• Intervention / Treatment: Behavioral: Intermittent Fasting; Behavioral: Standart Diet Therapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Beşiktaş
    • Istanbul, Beşiktaş, Turkey, 34353
      • Bahcesehir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Intermittent Fasting; A 16:8 intermittent fasting with a daytime eating window model was applied.
Experimental: 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.	Behavioral: Standart Diet Therapy; Meal plan with 3 main meals and 3 snacks was applied.
No Intervention: Free of dietary intervention; No dietary intervention was made and the individuals continued their current diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Indeks	weight (kg) and height (cm) will be combined to report BMI in kg/m^2	8 weeks
Body Fat Ratio	total fat ratio (%)	8 weeks
Body Water	Body water (ml)	8 weeks
Dietary Energy Intakes	Energy (kcal),	8 weeks
Energy Ratio from Macronutrients	Carbohydrate energy %, Protein energy % ,Fat energy %	8 weeks
Dietary Macronutrients Intakes	Macronutrients: carbohydrates (g), proteins (g), fats (g)	8 weeks
Dietary Micronutrients Intakes	Micronutrents: Vitamin and Mineral intakes will be presented as a percentage (%) of meeting the daily recommended intake.	8 weeks

Collaborators and Investigators

• Sponsor: Bahçeşehir University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): January 24, 2024

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: PCOS; Diet; IF
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Body Weight; Body Weight Changes; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Weight Loss; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: 12309112022

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
• product manufactured in and exported from the U.S.: No