Metabolic SyndromeNCT04893226
Circadian Rhythms in Postmenopausal Women
A study testing Time-Restricted Feeding (TRF) in people with Metabolic Syndrome and Postmenopausal Symptoms, run by Julie Pendergast at 1 site in United States.
Trial summary
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Postmenopausal Symptoms
- What is being tested?
- Time-Restricted Feeding (TRF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- postmenopausal women
- age 45-65 years
- prediabetic or have at least 2 features of metabolic syndrome
Who cannot join
- on hormone therapy
- diabetes
- heart disease
- alcohol consumption of >2 drinks per day
- significant circadian disruption
- having care-taking responsibilities that significantly affect sleep
Show all 15Show fewer
- shift work or irregular lifestyle
- uncontrolled sleep apnea or other uncontrolled sleep disorder
- extreme early or late chronotypes
- significant psychiatric disorders
- taking ADHD medications
- diagnosed dysregulated eating behaviors
- smoking >5 cigarettes/day or 30 pack-year history
- participating in formal weight loss program
- not weight stable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Matt Thomas, PhD, (859) 218-6770, jmthomg@uky.edu
About this study
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
Read the detailed description
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.
- Conditions
- Metabolic Syndrome, Postmenopausal Symptoms
- Being tested
- Time-Restricted Feeding (TRF)
- Keywords
- postmenopause, weight, metabolic risk, glucose, body composition, lipid, sleep, prediabetes, fasting, circadian, inflammation
- Medical subject headings
- Metabolic Syndrome, Body Weight, Prediabetic State, Fasting, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted Feeding (TRF)Behavioural
Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention. |
| Time-Restricted Feeding (TRF) Group | Experimental | Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks. Receives: Behavioral: Time-Restricted Feeding (TRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Measured: 18 weeks (baseline and post-intervention)
Change in Body Mass Index
Body mass index will be calculated from height and weight.
Measured: 18 weeks (baseline and post-intervention)
Change in Triglycerides
Triglycerides will be measured from fasting blood
Measured: 18 weeks (baseline and post-intervention)
Secondary outcomes (4)
Change in Hemoglobin A1c
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Measured: 18 weeks (baseline and post-intervention)
Change in C-Reactive Protein
CRP will be measured from blood samples.
Measured: 18 weeks (baseline and post-intervention)
Change in Mid-sleep
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Measured: 18 weeks (baseline and post-intervention)
Change in Sleep Fragmentation Index
Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.
Measured: 18 weeks (baseline and post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start19 Oct 2021
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie Pendergast
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Pendergast, University of Kentucky
- Investigators
- Julie S Pendergast, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893226
- Sponsor's protocol ID
- BIO-21-TRF
- Other IDs
- 1R01DK124774-01A1
- Status last verified
- Aug 2026
- First submitted
- 12 May 2021
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythms in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT04893226
- Acronym / sponsor ID
- BIO-21-TRF
- Conditions
- Metabolic Syndrome, Postmenopausal Symptoms
- Keywords
- postmenopause, weight, metabolic risk, glucose, body composition, lipid, sleep, prediabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Julie PendergastUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 19 May 2021 (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.
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
Detailed description
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention. |
| Time-Restricted Feeding (TRF) Group | Experimental | Behavioral: Time-Restricted Feeding (TRF)Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- postmenopausal women
- age 45-65 years
- prediabetic or have at least 2 features of metabolic syndrome
Key exclusion criteria (15 listed)
- on hormone therapy
- diabetes
- heart disease
- alcohol consumption of >2 drinks per day
- significant circadian disruption
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 Feeding (TRF)Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study. | Behavioural | Time-Restricted Feeding (TRF) Group |
Primary outcome
Change in Insulin Sensitivity
Time frame: 18 weeks (baseline and post-intervention)
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Change in Body Mass Index
Time frame: 18 weeks (baseline and post-intervention)
Body mass index will be calculated from height and weight.
Change in Triglycerides
Time frame: 18 weeks (baseline and post-intervention)
Triglycerides will be measured from fasting blood
4 secondary outcomes
Change in Hemoglobin A1c
Time frame: 18 weeks (baseline and post-intervention)
Change in C-Reactive Protein
Time frame: 18 weeks (baseline and post-intervention)
Change in Mid-sleep
Time frame: 18 weeks (baseline and post-intervention)
Change in Sleep Fragmentation Index
Time frame: 18 weeks (baseline and post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Julie S Pendergast, PhD principal investigator
University of Kentucky
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 (TRF) in people with Metabolic Syndrome and Postmenopausal Symptoms, run by Julie Pendergast at 1 site in United States.
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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Thomas, PhD ((859) 218-6770, jmthomg@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insulin Sensitivity (time frame: 18 weeks (baseline and post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.