Metabolic DiseasesBATSRNCT04168580
Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR)
A study testing Exercise Training Intervention in people with Metabolic Diseases, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- What is being tested?
- Exercise Training Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 23 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
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- 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.
- Group Specific Inclusion Criteria:
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32804
About this study
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.
Read the detailed description
Brown adipose tissue is a thermogenic tissue that contains large capacity to dissipate energy as heat. When activated by either cold-stimulation or increasing the amount of brown adipose tissue by transplantation, brown adipose tissue increases energy expenditure, decreases plasma glucose and lipids and improves systemic metabolism.
Brown adipose tissue has great potential as a therapeutic target to combat both metabolic and cardiovascular disease, but brown adipose tissue decreases with age. The objective 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. Studying the role of brown adipose tissue will potentially help us understand and prevent an accelerated aging process, which will help researchers better understand metabolic and cardiac health in the elderly.
- Conditions
- Metabolic Diseases
- Being tested
- Exercise Training Intervention
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| OA- Older Athlete | No intervention | Older adults who are regularly engaged in endurance exercise |
| OS- Older Sedentary | Active comparator | Older adults who are sedentary Receives: Other: Exercise Training Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Secondary outcomes (3)
Aerobic Fitness
As determine by a VO2max test
Measured: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Body Composition
Fat mass as determined by DEXA
Measured: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Muscle Testing - Power
Right leg extension power as determined by Biodex (180deg/s)
Measured: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start20 Oct 2020
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Paul Coen, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168580
- Sponsor's protocol ID
- 1456947
- Other IDs
- R01AG060542
- Acronym
- BATSR
- Status last verified
- Jul 2025
- First submitted
- 6 Nov 2019
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR)
- ClinicalTrials.gov ID
- NCT04168580
- Acronym / sponsor ID
- BATSR / 1456947
- Conditions
- Metabolic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brown adipose tissue is a thermogenic tissue that contains large capacity to dissipate energy as heat. When activated by either cold-stimulation or increasing the amount of brown adipose tissue by transplantation, brown adipose tissue increases energy expenditure, decreases plasma glucose and lipids and improves systemic metabolism.
Brown adipose tissue has great potential as a therapeutic target to combat both metabolic and cardiovascular disease, but brown adipose tissue decreases with age. The objective 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. Studying the role of brown adipose tissue will potentially help us understand and prevent an accelerated aging process, which will help researchers better understand metabolic and cardiac health in the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OA- Older Athlete | No intervention | –Older adults who are regularly engaged in endurance exercise |
| OS- Older Sedentary | Active comparator | Other: Exercise Training InterventionOlder adults who are sedentary |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Training InterventionOlder 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). | Other | OS- Older Sedentary |
Primary outcome
Collection of Imaging of BAT by Magnetic Resonance Imaging
Time frame: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Supraclavicular Adipose Tissue Proton Density Fat Fraction Percentage (PDFF %) is the primary outcome. PDFF % is determined by MRI
3 secondary outcomes
Aerobic Fitness
Time frame: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Body Composition
Time frame: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Muscle Testing - Power
Time frame: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Coen, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training Intervention in people with Metabolic Diseases, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Imaging of BAT by Magnetic Resonance Imaging (time frame: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.