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Time-Restricted eating: a simple diet hack to reverse prediabetes?

NCT ID NCT04057339

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Apr 2019

Finished

Oct 2024

Lead sponsor

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

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

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

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92093, United States

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Other studies related to the condition(s) this trial covers.