Trial Outcomes & Findings for Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR) (NCT NCT04168580)
NCT ID: NCT04168580
Last Updated: 2025-07-14
Results Overview
Supraclavicular Adipose Tissue Proton Density Fat Fraction Percentage (PDFF %) is the primary outcome. PDFF % is determined by MRI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and 8 weeks (or Post-Exercise Training - for OS group only)
Results posted on
2025-07-14
Participant Flow
Participant milestones
| Measure |
OA- Older Athlete
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
Older adults who are sedentary
Exercise Training Intervention: 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).
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brown Adipose Tissue as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence (BATSR)
Baseline characteristics by cohort
| Measure |
OA- Older Athlete
n=15 Participants
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
n=15 Participants
Older adults who are sedentary
Exercise Training Intervention: 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).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.47 Years
STANDARD_DEVIATION 4.16 • n=99 Participants
|
69.67 Years
STANDARD_DEVIATION 3.99 • n=107 Participants
|
69.57 Years
STANDARD_DEVIATION 4.01 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)Population: The OA group did not complete the exercise training intervention and so there was no 8 week/post-exercise data collected for this group.
Supraclavicular Adipose Tissue Proton Density Fat Fraction Percentage (PDFF %) is the primary outcome. PDFF % is determined by MRI
Outcome measures
| Measure |
OA- Older Athlete
n=15 Participants
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
n=15 Participants
Older adults who are sedentary
Exercise Training Intervention: 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).
|
|---|---|---|
|
Collection of Imaging of BAT by Magnetic Resonance Imaging
Baseline
|
78.69 Percentage
Standard Deviation 6.43
|
82.58 Percentage
Standard Deviation 7.28
|
|
Collection of Imaging of BAT by Magnetic Resonance Imaging
Post-Exercise Training
|
—
|
82.45 Percentage
Standard Deviation 6.37
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)Population: The OA group did not complete the exercise training intervention and so there was no 8 week/post-exercise data collected for this group.
As determine by a VO2max test
Outcome measures
| Measure |
OA- Older Athlete
n=15 Participants
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
n=15 Participants
Older adults who are sedentary
Exercise Training Intervention: 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).
|
|---|---|---|
|
Aerobic Fitness
Post Exercise Training
|
—
|
20.71 VO2max (mL/min/kg)
Standard Deviation 3.11
|
|
Aerobic Fitness
Baseline
|
30.4 VO2max (mL/min/kg)
Standard Deviation 5.97
|
20.57 VO2max (mL/min/kg)
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)Population: The OA group did not complete the exercise training intervention and so there was no 8 week/post-exercise data collected for this group.
Fat mass as determined by DEXA
Outcome measures
| Measure |
OA- Older Athlete
n=15 Participants
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
n=15 Participants
Older adults who are sedentary
Exercise Training Intervention: 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).
|
|---|---|---|
|
Body Composition
Baseline
|
19.23 Kg
Standard Deviation 6.52
|
26.96 Kg
Standard Deviation 8.57
|
|
Body Composition
Post Exercise Training
|
—
|
26.63 Kg
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks (or Post-Exercise Training - for OS group only)Population: The OA group did not complete the exercise training intervention and so there was no 8 week/post-exercise data collected for this group.
Right leg extension power as determined by Biodex (180deg/s)
Outcome measures
| Measure |
OA- Older Athlete
n=15 Participants
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
n=15 Participants
Older adults who are sedentary
Exercise Training Intervention: 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).
|
|---|---|---|
|
Muscle Testing - Power
Baseline
|
127.7 Watt
Standard Deviation 48.94
|
109.59 Watt
Standard Deviation 41.83
|
|
Muscle Testing - Power
Post Exercise Training
|
—
|
107.99 Watt
Standard Deviation 42.13
|
Adverse Events
OA- Older Athlete
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
OS- Older Sedentary
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OA- Older Athlete
n=15 participants at risk
Older adults who are regularly engaged in endurance exercise
|
OS- Older Sedentary
n=15 participants at risk
Older adults who are sedentary
Exercise Training Intervention: 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).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Runny nose, cough, sore throat
|
13.3%
2/15 • Number of events 2 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Gastrointestinal disorders
Nausea and Vomitting
|
6.7%
1/15 • Number of events 2 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
13.3%
2/15 • Number of events 2 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Nervous system disorders
Headache
|
13.3%
2/15 • Number of events 2 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
13.3%
2/15 • Number of events 2 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Blood and lymphatic system disorders
Left Arm Swelling at IV site
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Musculoskeletal and connective tissue disorders
lateral epicondylitis (tennis elbow)
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Blood and lymphatic system disorders
Issue with IV infiltration
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Renal and urinary disorders
Benign Prostatic Hyperplasia (BPH)
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Social circumstances
Fall - Outside Study (not related to study)
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/15 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
6.7%
1/15 • Number of events 1 • From Baseline to Week 8 (post exercise training) for the OS-Older Sedentary group only; and at Baseline for the OA-Older Athlete group.
Study participants were assessed for AE occurrence at every study visit.
|
Additional Information
Paul M. coen, PhD., Associate Investigator
AdventHealth Translational Research Institute
Phone: 765-426-9743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place