N/A
N=32
Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR)
Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04168580 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Collection of Imaging of BAT by Magnetic Resonance Imaging — 78.69; 82.58; 82.45 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise Training Intervention (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- AdventHealth Translational Research Institute
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Collection of Imaging of BAT by Magnetic Resonance Imaging |
78.69; 82.58; 82.45 | — |
| SECONDARY Aerobic Fitness |
30.4; 20.57; 20.71 | — |
| SECONDARY Body Composition |
19.23; 26.96; 26.63 | — |
| SECONDARY Muscle Testing - Power |
127.7; 109.59; 107.99 | — |
Summary
The goal of this study is to define the effect of aging on brown adipose tissue mass in a cohort of older sedentary and older athlete adults.
Eligibility Criteria
Inclusion Criteria
- Males and Females between the ages of 65 to 90 years of age.
- BMI 35kg/m2, inclusive at time of screening.
- Stable weight (No gain/loss of ≥ 10 lbs within 6 months prior to screening).
- Non-smokers as defined by not smoking any tobacco or using nicotine-containing products and not using vape pens or vaporizers within 3 months prior to screening.
- Participant must have renal function with an estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73m2 determined at screening.
- Triglyceride level is 3days/wk for >6 months without layoff. This will be verified by self-report and triaxial accelerometry.
- Older Sedentary (OS) Only: Defined as 150, Diastolic > 95).
- Mini Mental State Exam (MMSE) 2 days of hospitalization in the last 3 weeks prior to screening visit.
- Participant has an active malignancy (with the exception of basal cell) or autoimmune disease.
- Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
- Participant is an amputee and/or has presence of partial or full artificial limb.
- Participant currently has uncontrolled severe diarrhea, nausea or vomiting.
- Participant has uncontrolled severe (including stage III or above) gastrointestinal absorption-related disorders, within 3 months of screening, such as: obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome, gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis and bariatric surgery.
- Cannot abstain from alcohol for the duration of the testing periods.
- Subjects who fulfill any of the contraindications for MRI; examples include metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos.
- Unable to participate in Magnetic Resonance or DEXA assessments due to physical limitations of equipment tolerances (e.g., MRI bore size and DEXA 450-pound weight limit), claustrophobia, or based on Investigator's judgment at screening.
- Participant cannot refrain from taking medications/dietary supplements/herbals or substances that could modulate glucose metabolism, or are considered anabolic, or reduce weight (fat mass) in the opinion of the PI or Physician, starting two weeks prior to enrollment and over the entire course of the study. These include progestational agents, steroids, growth hormone, dronabinol, marijuana, calcium-betahydroxy-betamethylbutyrate (CaHMB), free amino acid supplements and dietary supplements to aid weight loss.
- Participant has hypothyroidism (0.5mI U/L) or hyperthyroidism (10mI U/L).
- Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.
- Because all women participating in this project will be post-menopausal, there will be no need for a pregnancy test prior to DEXA procedures. Females currently on hormone replacement therapy can participate in the study if they have been on a stable dose of Hormone Replacement Therapy (HRT) for at least 6 months and will continue to be on HRT during the study.
- Potential participants taking stable doses of medications for the last 30 days prior to screening for Blood pressure, cholesterol, gastroesophageal reflux disease (GERD) may be permitted to participate.
- Participant becomes Covid-19 positive at any point during the study.
Data sourced from ClinicalTrials.gov (NCT04168580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.