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Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 42 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how fat under the skin grows and changes during short-term weight gain. It also tests how these changes affect heart health and how the body uses energy. It is for men and women ages 18–42 who meet the study’s weight range; women must not have reached menopause.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be a man or a woman who has not reached menopause, age 18–42.
  • Have a BMI of 23–35, with 0.5 above or below accepted. BMI is a measure of weight compared with height.
  • Be willing to drink deuterium-labeled water, a special type of water, for 8 weeks.
  • Agree to be assigned by chance to a control group or a group that eats 30% extra food.
  • Women who do not use hormonal birth control must follow the study’s pregnancy prevention rules throughout the study. Options include approved barrier methods, an implant or IUD, having tubes tied, no sex, or an established relationship with a partner who has had a vasectomy or is the same sex.
  • Follow all study steps and attend all visits.
  • Keep the same level of physical activity throughout the study.
  • Allow blood samples to be stored for future research.

Who can't join

  • Weight changed by about 5% or more in the past 3 months, or past weight-loss surgery.
  • Type 1 or type 2 diabetes, blood sugar above 110 mg/dL after fasting, or average screening blood pressure above 140/90.
  • Major organ disease, such as heart, kidney, lung, thyroid, or liver disease, or liver blood tests that the study doctor finds concerning.
  • A reported positive test for HIV, hepatitis B, or hepatitis C; or cancer in the past 5 years, except some skin cancers.
  • Any past or current eating disorder, or a diagnosed mental health condition involving loss of touch with reality.
  • Long-term use of certain medicines, including steroids, beta-blockers, antipsychotics, or other drugs that may change weight; weight-loss drugs that could affect the study; or ongoing antidepressant use started less than 3 months ago.
  • Regular smoking or tobacco use if you cannot stop during overnight study stays.
  • Pregnancy, breastfeeding, plans to become pregnant in the next 6 months, removal of part or all of the uterus, or polycystic ovary syndrome (PCOS).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

LA