Time-Restricted Eating for Metabolic Syndrome

(TIMET 2 Trial)

Overseen By Gavin McLaren

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must be taking: Cardiovascular medications

Must not be taking: Sulfonylurea, Insulin

Disqualifiers: Pregnancy, Tobacco use, Cardiovascular event, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 54 weeks

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of time-restricted eating (TRE) on individuals with metabolic syndrome, a condition that includes high blood pressure and at least two other issues, such as a large waist size or high cholesterol. Participants will either maintain their usual eating habits or follow a 10-hour eating window. The trial aims to determine if TRE can improve health outcomes compared to standard care. Suitable candidates for this trial currently eat over a 12-hour span daily, have high blood pressure, and face issues like a large waist or abnormal cholesterol levels. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant health discoveries.

Will I have to stop taking my current medications?

The trial allows participants to continue taking their current cardiovascular medications if they have been on a stable dose for at least 3 months. However, if you are using sulfonylurea or insulin, you cannot participate in the trial.

Is there any evidence suggesting that time-restricted eating (TRE) is likely to be safe for humans?

Research has shown that time-restricted eating (TRE) is generally safe for most people, including those with metabolic syndrome. Studies have found that TRE can help people lose about 3% to 5% of their weight over a few months and improve heart health, all without serious side effects.

In past studies, TRE was associated with a better quality of life and improvements in health issues like obesity and diabetes, indicating good tolerance. Participants often experience positive changes without major health problems.

TRE may also reduce the risk of muscle loss, which can sometimes accompany weight loss. Overall, evidence suggests that TRE is a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this possible treatment for metabolic syndrome?

Researchers are excited about time-restricted eating (TRE) for metabolic syndrome because it offers a novel approach to managing the condition without changing what you eat, just when you eat. Unlike traditional treatments that often rely on medications like metformin or lifestyle changes focusing solely on diet or exercise, TRE involves limiting food intake to a consistent 10-hour window each day. This method could potentially improve metabolic health by aligning eating patterns with the body's natural circadian rhythms, which may enhance metabolism and reduce inflammation. Additionally, by integrating seamlessly with current lifestyle habits, TRE could increase adherence and effectiveness compared to more restrictive dietary plans.

What evidence suggests that time-restricted eating might be an effective treatment for metabolic syndrome?

Research has shown that time-restricted eating (TRE) can benefit people with metabolic syndrome. TRE involves eating only during a 10-hour window each day. Studies have found that this approach can lead to weight loss and a smaller waist size. It also helps control blood sugar and may improve heart health. One study showed that participants lost about 3% of their weight and had better heart health indicators. In this trial, participants in the TRE arm will follow a consistent 10-hour eating window daily, while those in the standard of care arm will maintain their current lifestyle without this restriction. These findings suggest that TRE could be a useful lifestyle change for those dealing with metabolic health issues. ^{3 6 7 8 9}

Who Is on the Research Team?

Pam Taub, MD

Principal Investigator

UC San Diego Health

Are You a Good Fit for This Trial?

This trial is for individuals with metabolic syndrome, who usually eat over a 12-hour period daily. They should have high blood pressure and at least two of these: large waist size, unusual cholesterol levels, high triglycerides, or elevated fasting glucose.

Inclusion Criteria

HbA1c: 5.7% to 7.0%

Own a smartphone (Apple iOS or Android OS)

Baseline eating period ≥12 hour/day

Exclusion Criteria

HbA1C > 7.0%

Pregnant or breastfeeding

Shift workers with variable hours

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a time-restricted eating pattern or standard of care for 54 weeks

54 weeks

3 visits (in-person) at the beginning, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time-restricted eating (TRE)

Trial Overview The study is testing the effects of time-restricted eating (TRE) where participants only eat during certain hours of the day. This group will be compared to another that follows standard health advice without TRE.

How Is the Trial Designed?

Group I: Time-restricted eating (TRE) Experimental Treatment 1 Intervention

Participants in this arm will be asked to maintain their current lifestyle and medication management routines, while adhering to a daily, consistent 10-hour eating window. They will also receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and are required to track their caloric intake using a smartphone app.

Group II: Standard of care (SOC) Placebo Group 1 Intervention

Participants in this arm will maintain their current lifestyle and medication management without adhering to the 10-hour eating window. They will receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and will be asked to track their caloric intake using a smartphone app.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Salk Institute for Biological Studies

Collaborator

Trials

23

Recruited

2,200+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771095

Effects of Time-Restricted Eating on Weight Loss and Other ... Wilkinson et al found that TRE was associated with an approximately 3% weight loss and improvements in cardiovascular risk markers in patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39348690/

Time-Restricted Eating in Adults With Metabolic Syndrome Conclusion: Personalized 8- to 10-hour TRE is an effective practical lifestyle intervention that modestly improves glycemic regulation and may ...

3. acpjournals.org acpjournals.org/doi/abs/10.7326/M24-0859

Time-Restricted Eating in Adults With Metabolic Syndrome Time-restricted eating (TRE) has been shown to produce weight loss and may provide cardiometabolic benefits, but prior studies have focused ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589004224002219

Time-restricted eating improves health because of energy ... The results showed that TRE led to modest weight loss, lower waist circumference and energy deficits. TRE also improved body mass index, fat ...

5. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.14814/phy2.70338

What are the effects of time‐restricted eating upon metabolic ... These studies, comprising 10 and 8 h TRE interventions for 12 weeks, showed mixed benefits to body composition markers such as body weight, fat ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11929607/

Time-Restricted Eating in Adults With Metabolic Syndrome This suggests that TRE likely poses a lower risk for sarcopenia associated with weight loss. Our findings contrast with a TRE intervention in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1550413123004540

Time-restricted eating: Watching the clock to treat obesity In participants with obesity, time-restricted eating results in 3%–5% weight loss over 2–12 months, versus controls. Reductions in body weight ...

8. academic.oup.com academic.oup.com/edrv/article/43/2/405/6371193

Time-restricted Eating for the Prevention and Management of ... Pilot human intervention studies have reported promising results in reducing the risk for obesity, diabetes, and cardiovascular diseases. Epidemiological ...

9. cell.com cell.com/cell-metabolism/pdfExtended/S1550-4131(22)00361-8

Feasibility of time-restricted eating and impacts on ... TRE was feasible and led to improvements in quality of life and cardiometabolic health, especially among participants with abnormal.