The Influence of Time-Restricted Eating in Patients With Metabolic Syndrome
(TIMET Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPam Taub, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

Trial Summary

What is the purpose of this trial?

In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 8-10 hour eating window for 12 weeks (TRE).

Eligibility Criteria

Inclusion Criteria

Baseline eating period ≥ 12 hour window

You have a phone that uses either Apple iOS or Android OS.

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.

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Exclusion Criteria

You have a chronic inflammatory or rheumatic disease.

You currently use tobacco or illegal drugs, or have received treatment for alcohol abuse in the past.

You have experienced a serious heart-related issue within the past year, such as a heart attack, heart surgery, or hospitalization for heart failure or stroke.

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Treatment Details

Interventions

Standard of Care (Behavioural Intervention)
Time Restricted Eating + Standard of Care (Behavioural Intervention)
Time Restricted Feeding + Standard of Care (Behavioural Intervention)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TRE + SOCExperimental Treatment1 Intervention

Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.

Group II: SOC (Standard of Care)Placebo Group1 Intervention

Everyone in this arm will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.