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Overfeeding Effects on Obesity (EAT 2 Trial)

N/A

Recruiting

Led By Ursula White, Ph.D.

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

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

Must have

Men and pre-menopausal women 18-42 years of age

Be between 18 and 65 years old

Must not have

Chronic use of prescription weight loss medications or over the counter weight loss medications which will impact the study

Previous bariatric or other surgeries for obesity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how fat tissue changes when people gain weight, and how this affects their health.

Who is the study for?

This trial is for men and pre-menopausal women aged 18-42 with a BMI of 25-30, willing to follow study procedures, maintain physical activity levels, drink labeled water for research, and use contraception if necessary. Excluded are those pregnant or planning pregnancy soon, with diabetes or high fasting blood glucose, high blood pressure, eating disorders, certain medication usage including weight loss drugs or antidepressants less than 3 months old.

What is being tested?

The study tests how short-term weight gain affects the ability of subcutaneous fat tissue to expand and remodel. Participants will be randomly assigned to either continue their normal diet (control group) or increase their calorie intake by 30% (overfeeding group), examining impacts on metabolic health outcomes.

What are the potential side effects?

There may not be direct side effects from the interventions as this is an observational study; however overfeeding could potentially lead to temporary weight gain and associated discomforts like bloating. Long-term risks include potential changes in metabolism or increased risk for obesity-related conditions.

Eligibility Criteria

Inclusion Criteria

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

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I am a man or a pre-menopausal woman aged 18-42.

Exclusion Criteria

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

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I regularly use weight loss medications that could affect the study.

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I have had surgery for weight loss.

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I do not have major organ disease or significant liver problems.

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I have had a partial or full hysterectomy.

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I have diabetes or my fasting blood sugar is over 110 mg/dL.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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

Adipose tissue expansion and remodeling -- in vivo adipocyte formation

Secondary study objectives

Adipose tissue expansion and remodeling -- in vivo triglyceride synthesis

Cardiometabolic health outcomes

Side effects data

From 2012 Phase 4 trial • 200 Patients • NCT01342510

30%

Pain with injection of propofol

100%

80%

60%

40%

20%

Study treatment Arm

Lidocaine/Magnesium

Control

Lidocaine

Magnesium

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: OverfeedingExperimental Treatment1 Intervention

The overfeeding group will be subjected to a similar relative change in energy intake, in which their dietary intake will be 30% more kcal/d than needed for weight maintenance.

Group II: ControlExperimental Treatment1 Intervention

The control group will be expected to maintain their weight within 1 kg of baseline weight throughout the duration of the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Control

2011

Completed Phase 4

~15780

Overfeeding

2016