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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a reliable way to measure brown adipose tissue (BAT) in both younger and older adults using MRI scans. BAT is a type of body fat that helps regulate body temperature and metabolism. Participants will undergo tests including BAT imaging, a fitness test to measure maximal oxygen consumption (VO2 max), and muscle function assessments. The trial seeks non-smokers with a stable weight who have not gained or lost more than 10 pounds in the past six months. Participants should not have diabetes or any recent serious health issues. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research in understanding body fat and metabolism.

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 prior data suggests that this method is safe for determining BAT mass?

Research has shown that imaging brown fat in the body is safe. One study introduced a new method called Cr-CEST MRI, which maps brown fat activity without using radiation or causing harm.

For testing VO2 max, research indicates it is safe for older adults, though it can be challenging. This test measures the body's oxygen use during exercise. While usually well-tolerated, some safety concerns exist due to its intensity.

Testing muscle function, particularly in older adults, is considered safe. A review found a very low risk of problems, ranging from 0.15% to 0.69%. This testing assesses muscle strength and power, which can decrease with age. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BAT imaging for aging because it offers a novel way to understand how brown adipose tissue (BAT) functions in different age groups. Unlike traditional methods that focus on treating symptoms, this approach aims to reveal underlying metabolic processes by using imaging to directly observe BAT activity. This could lead to more personalized strategies for managing age-related metabolic changes, potentially improving overall health and longevity. Moreover, combining BAT imaging with tests like maximal oxygen consumption (V02 max) and muscle function assessments could provide a comprehensive picture of how aging affects body systems, paving the way for innovative interventions.

What evidence suggests that this method is effective for determining BAT mass?

This trial will compare two age groups: a "Young group" (20-40 years) and an "Old group" (60-80 years). Research has shown that brown fat, or brown adipose tissue (BAT), plays a crucial role in maintaining warmth and supporting healthy aging. BAT helps regulate body temperature and is associated with improved exercise performance. Studies have found that more active BAT can lead to better health in older age. Additionally, VO2 max measures how efficiently the body uses oxygen during exercise, typically decreasing with age. However, staying active can help maintain a higher VO2 max, which is linked to increased longevity. Muscle strength and speed also tend to decline with age, but regular exercise can slow these changes and enhance overall physical ability. ^{6 7 8 9 10}

Who Is on the Research Team?

Paul Coen, PhD

Principal Investigator

Study principal investigator

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6702504/

ComBATing aging—does increased brown adipose tissue ... Brown and its related beige adipose tissue (BAT) play a definitive role in maintaining body temperature by producing heat through uncoupling ...

2. aging-us.com aging-us.com/article/206179/pdf

Brown adipose tissue enhances exercise performance and ... Brown adipose tissue (BAT), a major subtypes of adipose tissues, is known for thermogenesis and promoting healthful longevity. Our ...

3. nature.com nature.com/articles/s41419-022-04752-6

Adipose tissue aging: mechanisms and therapeutic ... The age-related redistribution of adipose tissue in favor of visceral depots impacts systematic healthy aging. Thus, fat redistribution during ...

4. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2019.00368/full

Brown and Beige Adipose Tissue and Aging In particular, it has been demonstrated that adipose-derived FGF21 increases the expression of UCP1 and other thermogenic genes in fat tissues in an autocrine/ ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2212877818311918

Identification of functional lipid metabolism biomarkers ... Brown adipose tissue aging is accompanied by impaired lipid metabolism. Phospholipids, sphingolipids and dolichols were positively correlated with BAT-aging.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0531556523001390

Brown adipose tissue and aging: A potential role for exercise This review is aimed to summarize the effects of aging and exercise training on BAT and could serve as a reference for developing prevention strategies.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12439256/

Imaging Brown Adipose Tissue: Current State and Future ... Nevertheless, the cohort data had age-related bias, as they enrolled participants aged 18 to 26 years to ensure the positive rate of BAT. Besides, models ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5485357/

Ageing is associated with brown adipose tissue remodelling ... Our results indicate that female C57BL/6 mice have a progressive age‐dependent loss of subcutaneous and visceral WAT browning.

9. nature.com nature.com/articles/s42255-024-01082-z

Non-invasive mapping of brown adipose tissue activity with ... This study establishes Cr-CEST MRI as a promising noninvasive and radiation-free approach for in vivo mapping of BAT activity.

10. jnm.snmjournals.org jnm.snmjournals.org/content/59/supplement_1/1249

Assessment of the aging of the brown adipose tissue by 18 F ... F-FDG PET/CT imaging technique was used to qualitatively and quantitatively analyze the relationship between 18F-FDG PET/CT imaging and aging of ...