Time-Restricted eating: a simple diet hack to reverse prediabetes?
NCT ID NCT04057339
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial tests whether time-restricted eating (TRE) — limiting all food intake to an 8-10 hour daily window — can improve blood sugar control and metabolic health in people with metabolic syndrome or prediabetes. Participants are randomly assigned to either standard nutritional counseling alone or counseling plus a 12-week TRE schedule. The study measures changes in blood sugar, insulin resistance, cholesterol, and body composition to see if this eating pattern helps regulate the body's daily metabolic rhythms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a behavioral intervention called time-restricted eating, where participants limit their daily food intake to an 8-10 hour window
- What this could lead to
- If it works, this could point toward a simple, drug-free way to improve blood sugar control and reduce metabolic syndrome risk.
- What could go wrong
- This is a relatively small, early-stage trial. The benefits may be modest, and sticking to a strict eating window can be challenging for many people.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
122 people
The number who actually took part.
- Started
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Apr 2019
- Finished
-
Oct 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 years 2. 41 ≥ BMI ≥ 25 AND 3. Metabolic syndrome, as defined as presence of 3 or more of the following criteria: Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% \< 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension 4. Own a smartphone (Apple iOS or Android OS) 5. Baseline eating period ≥ 12 hour window 6. If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive, anti-diabetes drugs), no dose adjustments will be allowed during the study period. Exclusion Criteria: 1. Taking insulin within the last 6 months. 2. Manifest diabetes, defined as HbA1c \> 7.0% given a 0.3% margin of error in lab readings, or diagnosis of diabetes. 3. Known inflammatory and/or rheumatologic disease. 4. Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse. 5. Pregnant or breast-feeding women. 6. Shift workers with variable (e.g. nocturnal) hours. 7. Caregivers for dependent requiring frequent nocturnal care/sleep interruptions. 8. Planned travel to a time zone with greater than a 3-hour difference during study period. 9. History of major adverse cardiovascular event within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack (TIA)). 10. Uncontrolled arrhythmia (i.e. rate-controlled atrial fibrillation/atrial flutter are not exclusion criteria). 11. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion). 12. History of adrenal disease. 13. History of malignancy undergoing active treatment, except non-melanoma skin cancer. 14. Known history of type I diabetes. 15. History of eating disorder(s). 16. History of cirrhosis. 17. History of stage 4 or 5 chronic kidney disease or requiring dialysis. 18. History of HIV/AIDS. 19. Currently enrolled in a weight-loss or weight-management program. 20. On a special or prescribed diet for other reasons (e.g. Celiac disease). 21. Currently taking any medication that is meant for, or has known effect on, appetite. 22. Any history of surgical intervention for weight management. 23. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness). 24. A score of \>16 on the Epworth Sleepiness Scale (ESS). 25. Depression determined by the Beck Depression Inventory (BDI) (unless previously diagnosed and well-controlled). 26. Failure to use the smartphone app for documentation (defined as \<2 meals/day for ≥3 days during baseline).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Altman Clinical and Translational Research Institute
La Jolla, California, 92093, United States
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