Eat in 10 hours, live better? new trial tests Time-Restricted eating for metabolic syndrome
NCT ID NCT07189234
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether limiting all eating to a consistent 10-hour window each day can improve blood sugar, cholesterol, and other health measures in people with metabolic syndrome or prediabetes. About 140 adults will either follow this eating schedule plus standard nutritional counseling, or receive counseling alone. The goal is to see if this simple lifestyle change can help control disease over the long term.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- time-restricted eating (10-hour eating window) plus nutritional counseling
- What this could lead to
- If successful, this could show that simply limiting when you eat each day helps manage blood sugar, cholesterol, and other heart-related risks without medication.
- What could go wrong
- This is a mid-stage trial with only 140 participants, so results may not apply to everyone. The intervention requires strict daily adherence, which may be hard to maintain long-term.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- 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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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. HbA1c: 5.7% to 7.0% 3. Metabolic syndrome (must meet 3 criteria): 1. Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy) 2. Elevated waist circumference: \- In Asians: ≥ 90 cm in men, ≥80 cm in women In all other races: ≥ 102 cm in men, ≥ 88 cm in women 3. Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides d) Reduced High-density lipoprotein (HDL)- cholesterol \< 40 mg/dL in males or \< 50 mg//dL in females, or drug treatment for reduced HDL-cholesterol e) Fasting glucose ≥ 100 mg/dL 4. Own a smartphone (Apple iOS or Android OS) 5. Baseline eating period ≥12 hour/day 6. Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors \[statins\]), other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), or anti-hypertensive drugs) for at least 1 month are allowed. 7. Patients on GLP-1 R agonists, SGLT2 inhibitors, or Metformin must be on stable doses for at least 3 months. Exclusion criteria: 1. Use of sulfonylurea or insulin. 2. HbA1C \> 7.0% 3. Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan. 4. Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions. 5. Shift workers with variable (e.g. nocturnal) hours. 6. Frequent travel to different time zones during the study period. 7. Active tobacco use or illicit drug use or history of treatment for alcohol abuse. 8. History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack). 9. History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators 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 1 diabetes. 15. History of an eating disorder. 16. History of cirrhosis. 17. History of stage 4 or 5 chronic kidney disease or requiring dialysis. 18. Currently enrolled in a weight-loss or weight-management program. 19. On a special or prescribed diet for other reasons (e.g. Celiac disease). 20. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness). 21. Inability or unwillingness to utilize the mCC app throughout study duration.
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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Altman Clinical and Translational Research Institute
RECRUITINGLa Jolla, California, 92093, United States
Contact Email: •••••@•••••
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