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Completed

NCT Number: NCT04580433

Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)

Intermittent fasting is an increasingly popular diet pattern of alternating eating and dieting.One particular form of intermittent fasting is the so-called time-restricted feeding (TRF). TRF allows for ad libitum feeding within a large window of time each day, and does not require any calorie counting. There is growing evidence that it can lose weight, reduce insulin resistance and improve cardiometabolic health. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disease affecting women of childbearing age. PCOS shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic changes. Insulin resistance and obesity are common features of PCOS. Whether the TRF impacts women with PCOS is still unknown due to the paucity of data in this area. To explore the effects of TRF on the endocrine and metabolic profile in overweight women with PCOS, a 6-week single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2) 5-week TRF period, will be implemented.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥ 18 years; BMI≥24kg/m2; Anovulation; Rott-PCOS.

Exclusion criteria

Taking weight loss or regulate hormone secretion medications in recent 6 months; The body weight fluctuated more than 5% in the past 3 months; Preparation for pregnancy, having been in pregnancy or lactation; Perimenopausal; Night-shift workers; Fasting more than 16 hours a day; Hypotension; Patients with other diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); Alcohol intake more than 100g per week; Smoking within 3 months; Engaging in high-intensity exercise.

Treatment and study plan

Time-restricted feeding

Behavioral

The trial consists of a 1-week baseline weight stabilization period followed by a 5-week TRF intervention period.

Participants will be instructed to eat freely from 8 a.m. to 4 p.m. daily and fast from 4 p.m. to 8 a.m. the next day.

Primary outcomes

  1. Insulin resistance

    Time frame: 5-week intervention period

    Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)

  2. Sex hormone-binding globulin (nmol/L)

    Time frame: 5-week intervention period

  3. Body Mass Index (BMI) (kg/m^2)

    Time frame: 5-week intervention period

    Weight (kg) and height (m) will be combined to report BMI

  4. Waist-to-Hip Ratio (WHR)

    Time frame: 5-week intervention period

    Waist and hip will be combined to report WHR

  5. Free androgen index (FAI) (%)

    Time frame: 5-week intervention period

  6. Total testosterone (TT) (ng/mL)

    Time frame: 5-week intervention period

  7. Area under the curve (AUC) for insulin

    Time frame: 5-week intervention period

    Insulin release test will be conducted

  8. Area under the curve (AUC) for glucose

    Time frame: 5-week intervention period

    Glucose tolerance test will be conducted

  9. Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose

    Time frame: 5-week intervention period

    Glucose tolerance test will be conducted

  10. Fasting insulin (FINS) (mU/L)

    Time frame: 5-week intervention period

  11. Fasting blood glucose (FBG) (mmol/L)

    Time frame: 5-week intervention period

Secondary outcomes

  1. Dietary behavior

    Time frame: 5-week intervention period

    Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire

  2. Time to return to normal menstrual cycle

    Time frame: 5-week intervention period

  3. Insulin-like growth factor 1 (IGF-1) (ng/mL)

    Time frame: 5-week intervention period

  4. Body fat (kg)

    Time frame: 5-week intervention period

    Measured by InBody, a body composition analyzer

  5. Body fat percentage (%)

    Time frame: 5-week intervention period

    Measured by InBody, a body composition analyzer

  6. Visceral fat area (cm^2)

    Time frame: 5-week intervention period

    Measured by InBody, a body composition analyzer

  7. Skeletal muscle content (kg)

    Time frame: 5-week intervention period

    Measured by InBody, a body composition analyzer

  8. High-sensitivity C-reactive protein (hs-CRP) (mg/L)

    Time frame: 5-week intervention period

    A kind of inflammatory biomarker

Other outcomes

  1. Luteinizing hormone (LH) (mIU/mL)

    Time frame: 5-week intervention period

  2. Follicle-stimulating hormone (FSH) (mIU/mL)

    Time frame: 5-week intervention period

  3. LH/FSH

    Time frame: 5-week intervention period

  4. Uric acid (UA) (umol/L)

    Time frame: 5-week intervention period

  5. Alanine aminotransferase (ALT) (U/L)

    Time frame: 5-week intervention period

  6. Aspartate aminotransferase (AST) (U/L)

    Time frame: 5-week intervention period

  7. Total cholesterol (TC) (mmol/L)

    Time frame: 5-week intervention period

  8. Triglycerides (TG) (mmol/L)

    Time frame: 5-week intervention period

  9. Low density lipoprotein-cholesterol (LDL-C) (mmol/L)

    Time frame: 5-week intervention period

  10. Body weight (kg)

    Time frame: 5-week intervention period

Sponsors and collaborators

Lead sponsor

Chunzhu Li

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome

Acronym: PCOS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Apr 19, 2021

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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