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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

B

Bahçeşehir University

Status

Completed

Conditions

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

Treatments

Behavioral: Standart Diet Therapy
Behavioral: Intermittent Fasting

Study type

Interventional

Funder types

Other

Identifiers

NCT06804044
12309112022

Details and patient eligibility

About

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

Full description

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

Enrollment

33 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 3 patient groups

Intermittent Fasting Diet Therapy
Experimental group
Description:
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.
Treatment:
Behavioral: Intermittent Fasting
Standart Diet Therapy
Experimental group
Description:
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.
Treatment:
Behavioral: Standart Diet Therapy
Free of dietary intervention
No Intervention group
Description:
No dietary intervention was made and the individuals continued their current diet.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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