BAT Imaging for Aging

(BATSP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Antimicrobials, Corticosteroids, Anti-inflammatories

Disqualifiers: Diabetes, Cardiovascular disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on prescription strength anti-inflammatory medication, you must not have taken it in the 6 weeks before screening.

What data supports the effectiveness of the treatment for BAT imaging in aging?

Research shows that brown adipose tissue (BAT) can be effectively identified and measured using imaging techniques like MRI and PET, which are less invasive and can help in understanding its role in metabolism and potential benefits for conditions like obesity and diabetes. ^{1 2 3 4 5}

Is BAT imaging safe for humans?

BAT imaging using MR and PET/MR techniques is generally considered safe, especially when low-dose tracers are used to minimize radiation exposure. MRI is preferred for children to avoid radiation, and studies have been conducted safely in healthy volunteers. ^{3 4 6 7 8}

How does the BAT Imaging for Aging treatment differ from other treatments for aging-related conditions?

The BAT Imaging for Aging treatment is unique because it uses infrared thermography (IRT) to non-invasively measure the activity of brown adipose tissue (BAT), which is involved in regulating body temperature and energy expenditure. This approach is less invasive and avoids radiation exposure compared to traditional methods like PET/CT scans, making it a novel way to assess BAT's role in managing obesity and metabolic disorders. ^{4 5 9 10 11}

What is the purpose of this trial?

The primary purpose of this protocol is to develop a reliable method to determine BAT mass in young and older adults by magnetic resonance imaging.

Research Team

Paul Coen, PhD

Principal Investigator

Study principal investigator

Eligibility Criteria

Adults aged 20-40 or 60-80 with a stable weight, BMI between 19.0 and 34.9, non-smokers for at least three months, and no significant recent medical history of diseases like uncontrolled diabetes or heart issues. Excludes those on certain medications, with metal implants incompatible with MRI, pregnant women, heavy drinkers, or anyone actively changing their diet.

Inclusion Criteria

Stable weight (No gain/loss of ≥ 10 lbs within 6 months prior to screening).

Capable of providing informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.

BMI ≥19.0 and ≤34.9 kg/m2, inclusive at time of screening.

Exclusion Criteria

You have taken strong anti-inflammatory medication prescribed by a doctor within the past 6 weeks before the screening.

You have experienced very bad diarrhea, nausea, or vomiting that was not under control within the past 3 months.

Impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo magnetic resonance imaging to determine BAT mass

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Brown adipose tissue (BAT) imaging
• Maximal oxygen consumption (V02 max)
• Muscle function testing

Trial Overview The trial is developing a method to measure the mass of brown adipose tissue (BAT) in young and older adults using MRI. It includes muscle function tests and measures maximal oxygen consumption to assess overall metabolic health.

Participant Groups

Group I: Young group Experimental Treatment 3 Interventions

20-40 years of age

Group II: Old group Experimental Treatment 3 Interventions

60-80 years of age

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hybrid PET/MRI as a tool to detect brown adipose tissue: Proof of principle. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Proton MR Spectroscopy Measurements of White and Brown Adipose Tissue in Healthy Humans: Relaxation Parameters and Unsaturated Fatty Acids. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Low-dose 18F-FDG TOF-PET/MR for accurate quantification of brown adipose tissue in healthy volunteers. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Measurement of human brown adipose tissue volume and activity using anatomic MR imaging and functional MR imaging. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An optimal condition for the evaluation of human brown adipose tissue by infrared thermography. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Brown Adipose Tissue: Multimodality Evaluation by PET, MRI, Infrared Thermography, and Whole-Body Calorimetry (TACTICAL-II). [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Association of Objectively Measured Physical Activity With Brown Adipose Tissue Volume and Activity in Young Adults. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Developments in the imaging of brown adipose tissue and its associations with muscle, puberty, and health in children. [2021]

9. Japan pubmed.ncbi.nlm.nih.gov

A new method of infrared thermography for quantification of brown adipose tissue activation in healthy adults (TACTICAL): a randomized trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Quantitation of brown adipose tissue perfusion in transgenic mice using near-infrared fluorescence imaging. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Whole Body and Regional Quantification of Active Human Brown Adipose Tissue Using 18F-FDG PET/CT. [2020]