Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR)

NCT04168580 | Completed Results DMC

• 2 other identifiers: 1456947R01AG060542
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Diseases

Outcome Measures

Primary Outcomes (1)

• Collection of Imaging of BAT by Magnetic Resonance Imaging

  Supraclavicular Adipose Tissue Proton Density Fat Fraction Percentage (PDFF %) is the primary outcome. PDFF % is determined by MRI

  Baseline and 8 weeks (or Post-Exercise Training - for OS group only)

Secondary Outcomes (3)

• Aerobic Fitness

  Baseline and 8 weeks (or Post-Exercise Training - for OS group only)

• Body Composition

  Baseline and 8 weeks (or Post-Exercise Training - for OS group only)

• Muscle Testing - Power

  Baseline and 8 weeks (or Post-Exercise Training - for OS group only)

Study Arms (2)

OA- Older Athlete

NO INTERVENTION

Older adults who are regularly engaged in endurance exercise

OS- Older Sedentary

ACTIVE COMPARATOR

Older adults who are sedentary

Other: Exercise Training Intervention

Interventions

Exercise Training Intervention OTHER

Older sedentary participants will undergo 8 weeks of exercise training. The exercise program will be supervised by a certified exercise physiologist and will take place at the AdventHealth Translational Research Institute (TRI) exercise training facility. Exercise compliance will be monitored for exercise training 4 days per week (32 total sessions). Aerobic training will be 30 minutes of brisk walking, jogging, cycle ergometry. Walking will be the primary mode of aerobic exercise given its widespread popularity and ease of administration across a broad segment of the older adult population. Walking will be at a moderate intensity and determined based on Heart Rate (50-70% of Maximal Heart Rate from most recent VO2max) and rating of perceived exertion using Borg's scale (ranges from 6 to 20).

OS- Older Sedentary

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
• States willingness to follow protocol as described, including the prescribed exercise level and completing any forms needed throughout the study.
• Voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
• Older Athletes (OA) Only: Endurance trained athletes, defined as exercising (running, cycling, swimming) \>3days/wk for \>6 months without layoff. This will be verified by self-report and triaxial accelerometry.
• Older Sedentary (OS) Only: Defined as \<1day/wk of structured exercise and determined by self-report and triaxial accelerometry.

You may not qualify if:

• History of type 1 or type 2 diabetes per self-report at screening visit 1.
• Actively pursuing weight loss and/or lifestyle changes at time of screening.
• Untreated or poorly controlled hypertension (Systolic \> 150, Diastolic \> 95).
• Mini Mental State Exam (MMSE) \<21.
• Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening. In the event of a positive stress test, participants are referred to their primary care physician. If the electrocardiogram (ECG) is determined to be a false positive, participant may be allowed to participate in study after confirmatory records obtained.
• Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
• Participant is currently taking anti-inflammatory medication or has had anti-inflammatory medication within 1 week prior to screening (including over the counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen, low dose aspirin).
• Surgery requiring \>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.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Paul M. coen, PhD., Associate Investigator
• Organization: AdventHealth Translational Research Institute

paul.coen@adventhealth.com

765-426-9743

Study Officials

• Paul Coen, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 19, 2019
• Study Start: October 20, 2020
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)