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Completed

NCT Number: NCT06804044

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

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

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Behavior Body Weight Body Weight Changes Caloric Restriction Cysts Endocrine System Diseases Fasting Feeding Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Intermittent Fasting Medical Nutrition Therapy Neoplasms Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Weight Loss

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bahçeşehir University

Istanbul, Beşiktaş, 34353, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent fasting

Behavioral

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

Standart Diet Therapy

Behavioral

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

Primary outcomes

  1. Body Weight lose

    Time frame: 8 weeks

    Total body weight (kg)

  2. Body Composition: Fat, Muscle

    Time frame: 8 weeks

    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).

  3. Body Circumference Measurements

    Time frame: 8 weeks

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

Secondary outcomes

  1. Body Mass Indeks

    Time frame: 8 weeks

    weight (kg) and height (cm) will be combined to report BMI in kg/m^2

  2. Body Fat Ratio

    Time frame: 8 weeks

    total fat ratio (%)

  3. Body Water

    Time frame: 8 weeks

    Body water (ml)

  4. Dietary Energy Intakes

    Time frame: 8 weeks

    Energy (kcal),

  5. Energy Ratio from Macronutrients

    Time frame: 8 weeks

    Carbohydrate energy %, Protein energy % ,Fat energy %

  6. Dietary Macronutrients Intakes

    Time frame: 8 weeks

    Macronutrients: carbohydrates (g), proteins (g), fats (g)

  7. Dietary Micronutrients Intakes

    Time frame: 8 weeks

    Micronutrents: Vitamin and Mineral intakes will be presented as a percentage (%) of meeting the daily recommended intake.

Sponsors and collaborators

Lead sponsor

Bahçeşehir University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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