NCT04583514 · Pennington Biomedical Research Center
Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
(EAT 2)
What this study is about
Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans.
View original scientific description
Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and pre-menopausal women
- 18-42 years of age
- BMI 23-35 kg/m2 (± 0.5 will be accepted)
- Are willing to drink deuterium-labeled water (2H2O) for 8 weeks
- Are willing to be randomized to either a CTL or 30% OF group
- For women, if not using pharmaceutical (hormonal) contraception (i.e. birth control pills, vaginal ring, injections, or implant), must agree to use either a double barrier method as a form of birth control to prevent pregnancy (i.e. male condom with spermicide, with or without cervical cap or diaphragm); use implants or intrauterine contraceptive devices; have a tubal ligation (surgically sterile); practice abstinence; or be in an established relationship with a vasectomized or same sex partner during the entire duration of the study
- Must be willing to adhere to all study procedures, including attendance at all study visits
- If enrolled, agree to maintain the same level of physical activity throughout the duration of the study
- Must be willing to have blood stored for future research
Exclusion criteria
- Unstable weight in the last 3 months (± \~5% weight change)
- Diagnosis of Type 1 or 2 diabetes or a fasting blood glucose \> 110 mg/dL
- Average screening blood pressure \> 140/90 mmHg
- Diagnosis of major organ disease (e.g. heart, kidney, lung, thyroid, liver disease) or abnormal liver enzymes that are, in the opinion of the MI, clinically significant and represent a problem for study inclusion.
- Self-reported positive test for human immunodeficiency virus, hepatitis B or hepatitis C
- Any current or previous eating disorders
- Chronic use of systemic glucocorticoids (steroids), systemic adrenergic-stimulating agents, beta-blockers, antipsychotic medications, thiazolidinediones and other medications that may cause clinically significant weight gain or loss)
- Chronic use of prescription weight loss medications or over the counter weight loss medications which, in the opinion of the MI, will impact the study
- Chronic use of anti-depressant medications for less than 3 months
- Chronic smokers or users of tobacco products who cannot abstain for the duration of the inpatient visits
- Previous bariatric or other surgeries for obesity
- Had cancer in the last 5 years (some skin cancers acceptable)
- Pregnancy, breastfeeding, or planned pregnancy for the upcoming 6 months
- Partial or full hysterectomy
- Diagnosed psychotic conditions.
Where
- Baton Rouge, Louisiana
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations