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

Primary Purpose

Polycystic Ovary Syndrome, Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Time-Restricted Feeding
Sponsored by
Chunzhu Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shengjing Hospital of China Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Time-Restricted Feeding

Arm Description

Participants will receive 16:8 TRF.

Outcomes

Primary Outcome Measures

Insulin resistance
Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)
Sex hormone-binding globulin (nmol/L)
Body Mass Index (BMI) (kg/m^2)
Weight (kg) and height (m) will be combined to report BMI
Waist-to-Hip Ratio (WHR)
Waist and hip will be combined to report WHR
Free androgen index (FAI) (%)
Total testosterone (TT) (ng/mL)
Area under the curve (AUC) for insulin
Insulin release test will be conducted
Area under the curve (AUC) for glucose
Glucose tolerance test will be conducted
Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose
Glucose tolerance test will be conducted
Fasting insulin (FINS) (mU/L)
Fasting blood glucose (FBG) (mmol/L)

Secondary Outcome Measures

Dietary behavior
Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire
Time to return to normal menstrual cycle
Insulin-like growth factor 1 (IGF-1) (ng/mL)
Body fat (kg)
Measured by InBody, a body composition analyzer
Body fat percentage (%)
Measured by InBody, a body composition analyzer
Visceral fat area (cm^2)
Measured by InBody, a body composition analyzer
Skeletal muscle content (kg)
Measured by InBody, a body composition analyzer
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
A kind of inflammatory biomarker

Full Information

First Posted
September 22, 2020
Last Updated
April 14, 2021
Sponsor
Chunzhu Li
Collaborators
National Natural Science Foundation of China
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1. Study Identification

Unique Protocol Identification Number
NCT04580433
Brief Title
Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)
Acronym
PCOS
Official Title
Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
January 16, 2021 (Actual)
Study Completion Date
January 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chunzhu Li
Collaborators
National Natural Science Foundation of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time-Restricted Feeding
Arm Type
Experimental
Arm Description
Participants will receive 16:8 TRF.
Intervention Type
Behavioral
Intervention Name(s)
Time-Restricted Feeding
Intervention Description
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 Outcome Measure Information:
Title
Insulin resistance
Description
Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)
Time Frame
5-week intervention period
Title
Sex hormone-binding globulin (nmol/L)
Time Frame
5-week intervention period
Title
Body Mass Index (BMI) (kg/m^2)
Description
Weight (kg) and height (m) will be combined to report BMI
Time Frame
5-week intervention period
Title
Waist-to-Hip Ratio (WHR)
Description
Waist and hip will be combined to report WHR
Time Frame
5-week intervention period
Title
Free androgen index (FAI) (%)
Time Frame
5-week intervention period
Title
Total testosterone (TT) (ng/mL)
Time Frame
5-week intervention period
Title
Area under the curve (AUC) for insulin
Description
Insulin release test will be conducted
Time Frame
5-week intervention period
Title
Area under the curve (AUC) for glucose
Description
Glucose tolerance test will be conducted
Time Frame
5-week intervention period
Title
Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose
Description
Glucose tolerance test will be conducted
Time Frame
5-week intervention period
Title
Fasting insulin (FINS) (mU/L)
Time Frame
5-week intervention period
Title
Fasting blood glucose (FBG) (mmol/L)
Time Frame
5-week intervention period
Secondary Outcome Measure Information:
Title
Dietary behavior
Description
Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire
Time Frame
5-week intervention period
Title
Time to return to normal menstrual cycle
Time Frame
5-week intervention period
Title
Insulin-like growth factor 1 (IGF-1) (ng/mL)
Time Frame
5-week intervention period
Title
Body fat (kg)
Description
Measured by InBody, a body composition analyzer
Time Frame
5-week intervention period
Title
Body fat percentage (%)
Description
Measured by InBody, a body composition analyzer
Time Frame
5-week intervention period
Title
Visceral fat area (cm^2)
Description
Measured by InBody, a body composition analyzer
Time Frame
5-week intervention period
Title
Skeletal muscle content (kg)
Description
Measured by InBody, a body composition analyzer
Time Frame
5-week intervention period
Title
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Description
A kind of inflammatory biomarker
Time Frame
5-week intervention period
Other Pre-specified Outcome Measures:
Title
Luteinizing hormone (LH) (mIU/mL)
Time Frame
5-week intervention period
Title
Follicle-stimulating hormone (FSH) (mIU/mL)
Time Frame
5-week intervention period
Title
LH/FSH
Time Frame
5-week intervention period
Title
Uric acid (UA) (umol/L)
Time Frame
5-week intervention period
Title
Alanine aminotransferase (ALT) (U/L)
Time Frame
5-week intervention period
Title
Aspartate aminotransferase (AST) (U/L)
Time Frame
5-week intervention period
Title
Total cholesterol (TC) (mmol/L)
Time Frame
5-week intervention period
Title
Triglycerides (TG) (mmol/L)
Time Frame
5-week intervention period
Title
Low density lipoprotein-cholesterol (LDL-C) (mmol/L)
Time Frame
5-week intervention period
Title
Body weight (kg)
Time Frame
5-week intervention period

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women with PCOS.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bing He, phD
Organizational Affiliation
Shengjing hospital affiliated to China Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chunzhu Li, MD
Organizational Affiliation
Shengjing hospital affiliated to China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33849562
Citation
Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2.
Results Reference
derived

Learn more about this trial

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

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