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NCT03459703 · ClinicalTrials.gov registry record · NA
Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
A NA study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT03459703 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 90 participants.
The verdict
NCT03459703, a NA study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of cardiovascular disease-even when food intake is matched to the control group or no weight loss occurs. Preliminary evidence suggests that TRF may also increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in humans. This study will test whether TRF enhances fat loss and increases weight loss in adults with obesity, relative to conventional dieting alone. In addition, this study will determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and will measure the feasibility and acceptability of TRF. In conjunction with the parent study described above, four ancillary studies will be conducted: 1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the secondary endpoints are salivary nitrate reductase activity and salivary bacterial abundance. 2. Effect of weight loss on several biomarkers related to kidney stones. The primary endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and creatinine. 3. Effect of meal timing on blood pressure regulation and kidney function. The primary endpoints of this ancillary study include urinary aldosterone excretion, sodium, potassium, and endothelin, whereas the secondary endpoints include nitric oxide and albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin, and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g., hydrogen peroxide and TBARs), and urinary exosomes. Urine will be anal
Interventions
- BEHAVIORAL Control Schedule
- BEHAVIORAL Early Time-Restricted Feeding
- BEHAVIORAL Structured Weight Loss Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2020-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03459703
The ClinicalTrials.gov registry entry for NCT03459703 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Control Schedule is the first listed.
NCT03459703 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03459703 about?
NCT03459703 is a clinical study titled "Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults". Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily. Several studies in rodents report that TRF reduces body weight, improves blood sugar control, and reduces the risk of...
What is the current status of trial NCT03459703?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2018-07-12. Estimated completion is 2020-04-30.
What interventions are being tested in trial NCT03459703?
The interventions under investigation include: Control Schedule (BEHAVIORAL), Early Time-Restricted Feeding (BEHAVIORAL), Structured Weight Loss Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT03459703?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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