Clinical trial Recruiting at 1 site Interventional Ages 18 to 42

Examining how fat tissue expands during overeating

Official title: Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

Run by Pennington Biomedical Research Center · NCT04583514 · Data updated 2026-11-12

This study is testing how fat tissue in the body changes when people overeat for a short time to see how it affects their overall health, especially regarding obesity and metabolic issues.

Quick facts

Study typeInterventional
Ages18 Years to 42 Years
SexAll
Enrollment58 (estimated)
SponsorPennington Biomedical Research Center
Academic / other
Locations1 site (Baton Rouge, Louisiana)
StatusRecruiting
StartedSeptember 15, 2020
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedApril 8, 2026
Trial IDNCT04583514 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men and pre-menopausal women aged 18-42 with a BMI between 23-35 kg/m2.

Probably not a fit

Patients outside the specified age range, gender, or BMI criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the ability of subcutaneous adipose tissue to expand and remodel in response to short-term weight gain through controlled overfeeding. It aims to understand the mechanisms behind adipose tissue expandability and its implications for metabolic health, particularly in relation to conditions like obesity and metabolic syndrome. Participants will be randomized into control or overfeeding groups and monitored for changes in adipose tissue and cardio-metabolic health outcomes. The study will utilize deuterium-labeled water to track metabolic changes over an 8-week period.

Why it matters

Potential benefit: If successful, this research could lead to better understanding and management of obesity-related health complications.

How similar studies have gone: While the specific approach of this study may be novel, previous research has indicated the importance of adipose tissue expandability in metabolic health.

Who can join: the full rules

Show full inclusion / exclusion criteria
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
* PCOS
* Diagnosed psychotic conditions.

Where it's running

  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana, United States
    Recruiting

Study contacts

  • Principal investigator: Ursula White, Ph.D. — Pennington Biomedical Research Center
  • Study coordinator: Ursula White, Ph.D.
  • Email: ursula.white@pbrc.edu
  • Phone: 225-763-2656

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.