Time for better time-restricted eating trials to lessen the burden of metabolic diseases.
Pam R Taub, Satchidananda Panda
https://pubmed.ncbi.nlm.nih.gov/35732151/Actively Recruiting
Led by University of California, San Diego · Updated on 2026-02-02
140
Participants Needed
1
Research Sites
26 weeks
Total Duration
Researchers are studying the effects of time-restricted eating TRE on patients with metabolic syndrome who have high blood pressure and at least two other metabolic risk factors, such as increased waist size, abnormal cholesterol, high triglycerides, or elevated fasting glucose. The study focuses on people who typically eat for more than 12 hours daily and aims to better understand how limiting eating to a 10-hour window daily may impact cardiometabolic health over a long period. Participants are randomly assigned to one of two groups one follows a daily 10-hour eating window combined with standard care and nutritional counseling, while the other continues their usual lifestyle without the eating window but also receives nutritional counseling. The study lasts 54 weeks and involves logging all food and drink intake using a smartphone app. Both groups receive lifestyle coaching and track their calories using the app. Throughout the study, researchers will measure height, weight, waist size, and blood pressure. Blood tests will check blood sugar control, insulin, lipids, and detailed cholesterol profiles. Participants will wear a continuous glucose monitor and an activity tracker at the start, six months, and the end of the study to monitor blood sugar, physical activity, and sleep. Body composition will be evaluated by DEXA scans, and an oral glucose tolerance test will assess how the body handles sugar. The main outcome is change in glucose levels after 54 weeks, along with other measures like cholesterol, insulin sensitivity, bone density, muscle mass, and body fat.
CONDITIONS
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
G
Gavin McLaren
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University of California, San Diego
Lead Sponsor
Salk Institute for Biological Studies
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Time-Restricted Eating (TRE) + Standard of Care | Standard of Care (SOC) Only |
|---|---|---|
| What is it? | A structured program combining daily time-restricted eating, in which participants consume all calories within a consistent 10-hour window, plus standard nutritional counseling from a dietician. | Standard nutritional counseling with no restrictions on when calories are consumed. Participants receive the same dietary advice but can eat at any time during the day. |
| Role in this study | Investigational intervention arm studying the effects of TRE plus nutritional counseling on cardiometabolic health. | Control arm reflecting current nutritional counseling standard of care for pre-diabetes and metabolic syndrome. |
| Primary use or purpose | To assess whether restricting eating to a consistent 10-hour window each day, when combined with nutritional counseling, improves glucose control and other metabolic health indicators compared to counseling alone. | To serve as a comparison to measure if dietary timing restriction provides added benefit over current nutritional counseling approaches for metabolic health and glucose control. |
| How is it given or performed? | Participants are instructed to eat all meals and snacks within the same self-selected 10-hour period each day. Ongoing support and nutritional counseling are provided throughout the study period by a dietician. Meal timing is logged and monitored, typically via an app or diary. | Participants receive nutritional counseling according to current guidelines but are not given guidance on timing their meals. No required eating window or meal timing restriction applies. |
| Evidence and maturity of evidence | Early evidence from small and short-term studies suggests time-restricted eating may improve metabolic parameters, but larger, long-term randomized trials are ongoing and conclusive benefits are not yet established. | Nutritional counseling is supported by extensive clinical evidence and remains the backbone of current management for metabolic syndrome and pre-diabetes. |
| Important limitations | Potential limitations include adherence challenges with a strict eating window in everyday life and lack of long-term data on sustainability and safety in diverse patient populations. | Standard nutritional counseling may not sufficiently address timing-related metabolic risk, and some individuals may achieve only modest benefit without additional strategies focused on meal timing. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 54 weeks
Participants follow a behavioral intervention where they either adhere to a daily, consistent 10-hour eating window with nutritional counseling or maintain their current lifestyle with nutritional counseling and track caloric intake using a smartphone app. They use the app throughout the study to log all food and beverage intake.
Regular meetings with a dietician and periodic assessments including blood tests, body measurements, and device wear at baseline, 6 months, and 12 months
Duration - Up to 12 months total from study start
Participants continue to be monitored for changes in cardiometabolic health parameters after the active intervention period.
Device-based monitoring with continuous glucose monitors and actigraphy devices worn for 2 weeks at baseline, 6 months, and 12 months
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Pam R Taub, Satchidananda Panda
https://pubmed.ncbi.nlm.nih.gov/35732151/University of California, San Diego
Lead Sponsor
Salk Institute for Biological Studies
Collaborating Sponsor