An interventional study of Time-Restricted Feeding (TRF) in Metabolic Syndrome and Postmenopausal Symptoms, sponsored by Julie Pendergast. Recruiting at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Julie Pendergast · Not applicable, Interventional, and Prevention
Among 579 studies in Metabolic Syndrome with a site in United States — 62 open to participants now, 84 under way, 3 of them phase 3. Metabolic Syndrome · United States.
Among the 579 studies in Metabolic Syndrome with a site in United States, this one is the 75th largest by planned enrollment of the 491 interventional ones, is one of 18 that started in 2021, is one of 346 with no phase, reaches primary completion later than 28 of the 82 other live ones, and was the 466th registered.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 164 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →62 of the 579 studies in Metabolic Syndrome with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 232 Metabolic Syndrome studies recruiting now, 68 (29%) set no upper age limit and 136 (59%) stop at 75 or younger; 20 take children under 18; 80 take healthy volunteers.
This study: 45 Years to 65 Years · female · healthy volunteers too.
The full table on the hub →579 studies; the count open now beside each. This study's row is marked.
First in 1982; this study’s year is marked. 18 started in 2021.
Median enrollment 48 across the 491 interventional studies, 141 across the 86 observational. Of the 443 that completed or were terminated, 136 (31%) have results posted.
47 of 579 have an industry lead sponsor. The 10 most frequent:
Julie Pendergast is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Julie Pendergast has 1 study filed under Metabolic Syndrome — fewer than ten, so there is no comparison to draw.
29 of the studies in Metabolic Syndrome with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07625332Phase 3Northwell HealthPilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI) | 2027-08 |
| NCT07095426Ball State UniversityImpact of Supplemental Fiber on Gut and Vascular Health Related in Obesity Phenotypes | 2026-11 |
| NCT05121844Signos IncUse of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform | 2026-11-01 |
| NCT04974554Medical University of South CarolinaFIT Families Multicomponent Obesity Intervention for African American Adolescents | 2026-11-30 |
| NCT05943626University of UtahCircadian Intervention to Improve Cardiometabolic Health | 2026-12 |
Among the 579 studies in Metabolic Syndrome with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Behavioral: 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.
Change in Insulin Sensitivity
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Time frame: 18 weeks (baseline and post-intervention)
Change in Body Mass Index
Body mass index will be calculated from height and weight.
Time frame: 18 weeks (baseline and post-intervention)
Change in Triglycerides
Triglycerides will be measured from fasting blood
Time frame: 18 weeks (baseline and post-intervention)
Change in Hemoglobin A1c
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Time frame: 18 weeks (baseline and post-intervention)
Change in C-Reactive Protein
CRP will be measured from blood samples.
Time frame: 18 weeks (baseline and post-intervention)
Change in Mid-sleep
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Time frame: 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.
Time frame: 18 weeks (baseline and post-intervention)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Jan 2027, 63 months after the start.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 63 months is above that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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Julie Pendergast