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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
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 belowSelect...
I am a man or a pre-menopausal woman aged 18-42.
EAT 2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 • NCT0134251030%
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
305 Previous Clinical Trials
181,978 Total Patients Enrolled
65 Trials studying Obesity
117,565 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,369 Previous Clinical Trials
4,316,539 Total Patients Enrolled
450 Trials studying Obesity
589,129 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly use weight loss medications that could affect the study.You have been diagnosed with a mental condition that causes you to lose touch with reality.I am not on long-term medications that significantly affect my weight.I have had surgery for weight loss.Your weight has been changing a lot in the past 3 months, by about 7 pounds up or down.You have tested positive for HIV, hepatitis B, or hepatitis C.I do not have major organ disease or significant liver problems.I have had a partial or full hysterectomy.I agree to use effective birth control or practice abstinence during the study.I am a man or a pre-menopausal woman aged 18-42.You have a history of eating disorders.I have had cancer within the last 5 years, but skin cancer might be an exception.I am willing to be assigned to one of two treatment groups by chance.You have smoked or used tobacco products in the past 3 months.Polycystic ovary syndrome (PCOS)I have been using anti-depressants for less than 3 months.Your body mass index (BMI) is between 25 and 30 kg/m2.I have diabetes or my fasting blood sugar is over 110 mg/dL.Your average blood pressure during screening is higher than 140/90 mmHg.I am willing to drink a special type of water for 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Overfeeding
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Who else is applying?
What site did they apply to?
Pennington Biomedical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
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