Examining how fat tissue expands during overeating
Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT04583514 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men and pre-menopausal women aged 18-42 with a BMI between 23-35 kg/m2.
Not a fit: Patients outside the specified age range, gender, or BMI criteria may not benefit from this study.
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 performed: While the specific approach of this study may be novel, previous research has indicated the importance of adipose tissue expandability in metabolic health.
Eligibility criteria
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 this trial is running
Baton Rouge, Louisiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.