Polycystic Ovary SyndromePCOSNCT04580433

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

A study testing Time-Restricted Feeding in people with Polycystic Ovary Syndrome and Overweight, run by Chunzhu Li at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Polycystic Ovary Syndrome, Overweight, Obesity
What is being tested?: Time-Restricted Feeding
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteChina
Study dates: 1 Nov 2020to 16 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004

Other trials in China

About this study

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

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.

Conditions: Polycystic Ovary Syndrome, Overweight, Obesity
Being tested: Time-Restricted Feeding
Medical subject headings: Polycystic Ovary Syndrome, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time-Restricted FeedingBehavioural
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.

Study groups in NCT04580433
Study group	Role	What they receive
Time-Restricted Feeding	Experimental	Participants will receive 16:8 TRF. Receives: Behavioral: Time-Restricted Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

Insulin resistance
Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)
Measured: 5-week intervention period
Sex hormone-binding globulin (nmol/L)
Measured: 5-week intervention period
Body Mass Index (BMI) (kg/m^2)
Weight (kg) and height (m) will be combined to report BMI
Measured: 5-week intervention period
Waist-to-Hip Ratio (WHR)
Waist and hip will be combined to report WHR
Measured: 5-week intervention period
Free androgen index (FAI) (%)
Measured: 5-week intervention period
Total testosterone (TT) (ng/mL)
Measured: 5-week intervention period
Area under the curve (AUC) for insulin
Insulin release test will be conducted
Measured: 5-week intervention period
Area under the curve (AUC) for glucose
Glucose tolerance test will be conducted
Measured: 5-week intervention period
Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose
Glucose tolerance test will be conducted
Measured: 5-week intervention period
Fasting insulin (FINS) (mU/L)
Measured: 5-week intervention period
Fasting blood glucose (FBG) (mmol/L)
Measured: 5-week intervention period

Secondary outcomes (8)

Dietary behavior
Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire
Measured: 5-week intervention period
Time to return to normal menstrual cycle
Measured: 5-week intervention period
Insulin-like growth factor 1 (IGF-1) (ng/mL)
Measured: 5-week intervention period
Body fat (kg)
Measured by InBody, a body composition analyzer
Measured: 5-week intervention period
Body fat percentage (%)
Measured by InBody, a body composition analyzer
Measured: 5-week intervention period
Visceral fat area (cm^2)
Measured by InBody, a body composition analyzer
Measured: 5-week intervention period
Skeletal muscle content (kg)
Measured by InBody, a body composition analyzer
Measured: 5-week intervention period
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
A kind of inflammatory biomarker
Measured: 5-week intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202016 Jan 2021

First posted8 Oct 2020
Study start1 Nov 2020
Primary completion16 Jan 2021
Study completion16 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04580433
Sponsor's protocol ID: 2020161820
Acronym: PCOS
Status last verified: Apr 2021
First submitted: 22 Sep 2020
Last updated: 19 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33849562

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome
ClinicalTrials.gov ID: NCT04580433
Acronym / sponsor ID: PCOS / 2020161820
Conditions: Polycystic Ovary Syndrome, Overweight, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Chunzhu LiUniversity, hospital or other
Collaborators: National Natural Science Foundation of China
Study start: 1 Nov 2020 (actual)
Primary completion: 16 Jan 2021 (actual)
Study completion: 16 Jan 2021 (actual)
First posted: 8 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Time-Restricted Feeding	Experimental	Behavioral: Time-Restricted FeedingParticipants will receive 16:8 TRF.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Time-Restricted FeedingThe 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.	Behavioural	Time-Restricted Feeding

Primary outcome

Insulin resistance
Time frame: 5-week intervention period
Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)
Sex hormone-binding globulin (nmol/L)
Time frame: 5-week intervention period
Body Mass Index (BMI) (kg/m^2)
Time frame: 5-week intervention period
Weight (kg) and height (m) will be combined to report BMI
Waist-to-Hip Ratio (WHR)
Time frame: 5-week intervention period
Waist and hip will be combined to report WHR
Free androgen index (FAI) (%)
Time frame: 5-week intervention period
Total testosterone (TT) (ng/mL)
Time frame: 5-week intervention period
Area under the curve (AUC) for insulin
Time frame: 5-week intervention period
Insulin release test will be conducted
Area under the curve (AUC) for glucose
Time frame: 5-week intervention period
Glucose tolerance test will be conducted
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
Fasting insulin (FINS) (mU/L)
Time frame: 5-week intervention period
Fasting blood glucose (FBG) (mmol/L)
Time frame: 5-week intervention period

8 secondary outcomes

Dietary behavior
Time frame: 5-week intervention period
Time to return to normal menstrual cycle
Time frame: 5-week intervention period
Insulin-like growth factor 1 (IGF-1) (ng/mL)
Time frame: 5-week intervention period
Body fat (kg)
Time frame: 5-week intervention period
Body fat percentage (%)
Time frame: 5-week intervention period
Visceral fat area (cm^2)
Time frame: 5-week intervention period
Skeletal muscle content (kg)
Time frame: 5-week intervention period
High-sensitivity C-reactive protein (hs-CRP) (mg/L)
Time frame: 5-week intervention period

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Derived from this study: PubMed 33849562Li 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.
Individual participant dataSharing planned: No

Related trials for Polycystic Ovary Syndrome

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bing He, phD principal investigator

Shengjing Hospital

Chunzhu Li, MD principal investigator

Shengjing Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Time-Restricted Feeding in people with Polycystic Ovary Syndrome and Overweight, run by Chunzhu Li at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin resistance (time frame: 5-week intervention period). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04580433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.