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Time-Restricted Eating for Obesity

N/A

Waitlist Available

Led By Michael J Wilkinson, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 drugs, no dose adjustments will be allowed during the study period.

BMI 30-50 kg/m2

Must not have

Known inflammatory and/or rheumatologic disease

History of surgical intervention for weight loss

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 14 weeks

Summary

This trial will compare the health impact of time-restricted eating in obese patients to standard nutritional counseling.

Who is the study for?

Adults over 18 with obesity (BMI of 30-50), who eat for more than 14 hours a day and own a smartphone. They must not be on any weight-affecting meds, pregnant, or have various health conditions like heart failure or uncontrolled psychiatric disorders. Those on stable cardiovascular meds can join but can't change doses during the trial.

What is being tested?

The study is testing if limiting eating to a 10-hour window (Time-Restricted Eating) plus nutritional counseling affects obese adults' health differently compared to just nutritional counseling alone. Participants will follow their assigned eating plan for 12 weeks.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include hunger outside of the eating window, potential changes in energy levels, mood alterations due to diet change, and possible impact on social life or routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not changing my heart or cholesterol medication doses during the study.

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My BMI is between 30 and 50.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a diagnosed inflammatory or rheumatologic condition.

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I have had surgery to help me lose weight.

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I have a history of adrenal gland problems.

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I have been on insulin or diabetes medication in the last 6 months.

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I am taking medication that affects my appetite or weight.

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I have had a bone marrow or solid organ transplant.

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I have a history of heart failure.

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I have diabetes based on my blood sugar or HbA1c levels.

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I have a history of HIV/AIDS.

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I have a history of cirrhosis.

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I have a history of irregular heartbeats.

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I have had a serious heart or stroke event in the past.

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I have severe kidney disease or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 14 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 14 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 14 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effects of TRE on body composition

Effects of TRE on body weight

Effects of TRE on catecholamine sensitivity of obese adipose tissue (Exploratory Outcome)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TRE + SOCExperimental Treatment1 Intervention

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

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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time Restricted Eating

2018

N/A

~50

0 / 16Eligibility criteria met