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Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS) (TRF-PCOS)

Primary Purpose

Polycystic Ovary Syndrome (PCOS), Overweight and Obesity

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Time Restricted Feeding

Usual care

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS) focused on measuring Polycystic Ovary Syndrome, Overweight and Obesity, Time-Restricted Feeding, Intermittent fasting regimens

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
BMI≥24kg/m2
Polycystic ovary syndrome has been diagnosed

Exclusion Criteria:

Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
The body weight fluctuated more than 5% in recent 3 months.
Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
History of thyroid diseases;
Having been in pregnancy.
Researchers believe that there are any factors that affect assessing subjects' participation in trial.
History of malignant tumors;
History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight)
Patients who cannot be followed for 16 months (due to a health situation or migration)
Patients who are unwilling or unable to give informed consent.

Sites / Locations

The first afilliated hospital of Xiamen university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TRF

Usual care

Arm Description

Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.

Participants in this group will receive a general lifestyle counseling.

Outcomes

Primary Outcome Measures

Changes in body weight (Kilograms)

Change in insulin resistance

Insulin resistance will be assessed by HOMA-IR

Secondary Outcome Measures

Changes in waist circumference (cm)

Changes in abdominal circumference (cm)

Changes in systolic pressure（SBP）

Changes in diastolic pressure (DBP）

Change in β cell function

β cell function will be assessed by HOMA-β

Change in LDL-c level

Change in TG level

Change in CHO level

Change in liver fiber

liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan

Changes in systemic Inflammatory biomarkers

Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).

Changes in Oxidative stress markers

Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.

Change in depressive symptoms as assessed by Patient Health Questionnaire-9

Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)

Changes in time to return to normal menstrual cycle

Full Information

NCT ID

NCT03792282

First Posted

December 30, 2018

Last Updated

August 19, 2023

Sponsor

The First Affiliated Hospital of Xiamen University

1. Study Identification

Unique Protocol Identification Number

NCT03792282

Brief Title

Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)

Acronym

TRF-PCOS

Official Title

Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome(PCOS): A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

January 7, 2019 (Actual)

Primary Completion Date

June 30, 2023 (Actual)

Study Completion Date

July 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.

Detailed Description

Intermittent fasting regimens involve periods fasting followed by periods of eating freely. Time-Restricted Feeding (TRF) is a new form of intermittent fasting and involves shortening the eating window to 4-10 h/day. TRF is a safe lifestyle intervention for weight loss in adults with obesity. Accumulating evidence suggests that TRF is an effective means of decreasing body weight and improving insulin resistance but did not have any negative impact on eating disorder symptoms, body image perception, or eating behaviors. Polycystic ovary syndrome (PCOS) is the most common endocrine condition in productive-aged women. About 60-70 % of women with PCOS are obese or overweight, and obesity is associated with insulin resistance. Since many women with PCOS seem to have insulin resistance, compensatory hyperinsulinemia is thought to contribute to hyperandrogenism by direct stimulation of ovarian production of androgens and by inhibition of liver synthesis of SHGB. It is important to ameliorate insulin resistance in PCOS patients.The aims of the present study is to examine whether TRF is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese PCOS patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome (PCOS), Overweight and Obesity

Keywords

Polycystic Ovary Syndrome, Overweight and Obesity, Time-Restricted Feeding, Intermittent fasting regimens

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TRF

Arm Type

Experimental

Arm Description

Participants in this group will focus on time restricted feeding (TRF) in addition to daily calorie restriction.

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Participants in this group will receive a general lifestyle counseling.

Intervention Type

Behavioral

Intervention Name(s)

Time Restricted Feeding

Intervention Description

Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).

Intervention Type

Behavioral

Intervention Name(s)

Usual care

Intervention Description

Participants receive a general lifestyle counseling.

Primary Outcome Measure Information:

Title

Changes in body weight (Kilograms)

Description

Changes in body weight (Kilograms)

Time Frame

Baseline and 16 weeks

Title

Change in insulin resistance

Description

Insulin resistance will be assessed by HOMA-IR

Time Frame

Baseline and 16 weeks

Secondary Outcome Measure Information:

Title

Changes in waist circumference (cm)

Time Frame

Baseline and 16 weeks

Title

Changes in abdominal circumference (cm)

Time Frame

Baseline and 16 weeks

Title

Changes in systolic pressure（SBP）

Time Frame

Baseline and 16 weeks

Title

Changes in diastolic pressure (DBP）

Time Frame

Baseline and 16 weeks

Title

Change in β cell function

Description

β cell function will be assessed by HOMA-β

Time Frame

Baseline and 16 weeks

Title

Change in LDL-c level

Time Frame

Baseline and 16 weeks

Title

Change in TG level

Time Frame

Baseline and 16 weeks

Title

Change in CHO level

Time Frame

Baseline and 16 weeks

Title

Change in liver fiber

Description

liver fiber will be assessed by Controlled attenuation parameter (CAP) evaluated with transient elastography (FibroScan®) Fibroscan

Time Frame

Baseline and 16 weeks

Title

Changes in systemic Inflammatory biomarkers

Description

Inflammatory biomarkers (TNFa,CRP and Interleukin-6) are measured by ELISA (enzyme-linked immunosorbent assay).

Time Frame

Baseline and 16 weeks

Title

Changes in Oxidative stress markers

Description

Oxidative stress markers include the circulating levels of Catalase,Glutathione Peroxidase, and Malondialdehyde.

Time Frame

Baseline and 16 weeks

Title

Change in depressive symptoms as assessed by Patient Health Questionnaire-9

Time Frame

Baseline and 16 weeks

Title

Change in quality of life measured by the 12-item Short-Form Health Survey Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)

Time Frame

Baseline and 16 weeks

Title

Changes in time to return to normal menstrual cycle

Description

Changes in time to return to normal menstrual cycle

Time Frame

Baseline and 16 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Only women have the PCOS.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years BMI≥24kg/m2 Polycystic ovary syndrome has been diagnosed Exclusion Criteria: Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician; The body weight fluctuated more than 5% in recent 3 months. Liver and kidney dysfunction: renal impairment, creatinine clearance rate < 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit; History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months; History of thyroid diseases; Having been in pregnancy. Researchers believe that there are any factors that affect assessing subjects' participation in trial. History of malignant tumors; History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity; Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) Patients who cannot be followed for 16 months (due to a health situation or migration) Patients who are unwilling or unable to give informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changqin Liu, MD

Organizational Affiliation

The first afilliated hospital of Xiamen university

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first afilliated hospital of Xiamen university

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33512717

Citation

Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.

Results Reference

derived

Learn more about this trial

Time-Restricted Feeding(TRF) on Overweight/Obese Women With Polycystic Ovarian Syndrome (PCOS)

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