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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
For women not using pharmaceutical (hormonal) contraception, must agree to use either a double barrier method as a form of birth control to prevent pregnancy, use implants or intrauterine contraceptive devices, have a tubal ligation, practice abstinence, or be in an established relationship with a vasectomized or same sex partner during the entire duration of the study
Men and pre-menopausal women 18-42 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

EAT 2 Trial 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.Check my eligibility
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.See study design
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.

EAT 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control or practice abstinence during the study.
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I am a man or a pre-menopausal woman aged 18-42.
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I am willing to be assigned to one of two treatment groups by chance.
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I am willing to drink a special type of water for 8 weeks.

EAT 2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adipose tissue expansion and remodeling -- in vivo adipocyte formation
Secondary outcome measures
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%
0%
Study treatment Arm
Lidocaine/Magnesium
Control
Lidocaine
Magnesium

EAT 2 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
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
301 Previous Clinical Trials
180,756 Total Patients Enrolled
64 Trials studying Obesity
117,477 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,350 Total Patients Enrolled
443 Trials studying Obesity
588,271 Patients Enrolled for Obesity
Ursula White, Ph.D.Principal Investigator - Pennington Biomedical Research Center
Pennington Biomedical Research Center
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

Control Clinical Trial Eligibility Overview. Trial Name: NCT04583514 — N/A
Obesity Research Study Groups: Control, Overfeeding
Obesity Clinical Trial 2023: Control Highlights & Side Effects. Trial Name: NCT04583514 — N/A
Control 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583514 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for enrollment in this clinical trial greater than sixty years?

"To participate in this research study, the individual must be between 18 and 42 years old. There are 65 trials for minors and 303 for those older than 65."

Answered by AI

How many participants is the study seeking to involve?

"Affirmative. The information found on clinicaltrials.gov supports that this research is currently recruiting individuals for participation. First announced on September 15th 2020, the study was most recently updated on January 27th 2022 and seeks to enrol 70 participants from a single medical centre."

Answered by AI

Are there any open slots available for participation in this clinical trial?

"Affirmative. The clinicaltrials.gov website documents that this research is currently enrolling patients, with the initial post appearing on September 15th 2020 and last update occuring January 27th 2022 . This trial aims to recruit 70 people from a single medical center."

Answered by AI

Am I a qualified participant of this research project?

"This research endeavour is recruiting 70 individuals with metabolic syndrome, aged 18 to 42. To be eligible for the study, participants must meet the following criteria: male or pre-menopausal female; body mass index between 25 and 30 kg/m2 (± 0.5 will be accepted); agreement to consume deuterium-labeled water (2H2O) over an 8 week period; willingness to remain physically active throughout their participation in this trial; consenting to random assignment into either a control group or receiving prescribed intervention ; and commitment towards full adherence of all procedures mandated by the clinical trial."

Answered by AI
~19 spots leftby Dec 2025