Active — Not RecruitingNot Applicable

Adaptation of Human Brown Adipose Tissue to Calorie Restriction

Spain30 participantsStarted 2025-01-25

Plain-language summary

The BATON study investigates how human brown adipose tissue (BAT) adapts to a controlled caloric restriction diet in young adults with obesity. A weight maintenance diet group will be compared to a group following a diet designed to induce an 8-10% weight loss over a 12-16 week period. Outcome assessments will include advanced technologies such as PET-CT and molecular analyses of BAT. The overarching goal is to gain a deeper understanding of the role of human BAT on the regulation of body weight.

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Body mass index (BMI) of 27-40 kg/m², with a body fat percentage (determined by DXA, Hologic Wi) exceeding 25% in men and 30% in women. * Reported stable body weight over the preceding 3 months (body weight changes of less than 3%). * Laboratory safety test results (general biochemistry and complete blood count) within the normal reference range or with abnormalities deemed clinically insignificant by the medical research team and not requiring pharmacological treatment. * Adequate venous access for blood sampling required by the procedures described in this protocol and absence of needle, blood, or medical procedure phobia. * Readiness and ability to consume all foods included in the assessments and dietary intervention. * Ability to understand and comply with study procedures, as assessed by the research team. * Availability to participate in the study. * Commitment to completing the study regardless of the assigned group. Exclusion Criteria: * Diagnosis or presence of signs or symptoms that, in the opinion of the research team, may contraindicate the dietary intervention or any of the procedures included in the study. * Diagnosis or history of metabolic (including any type of diabetes mellitus), hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urologic, or psychiatric diseases that could interfere with study outcomes or protocol adherence. * History of any surgical procedure that, in the opinion of the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BAT volume

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

BAT 18F-FDG uptake upon cold exposure

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

BAT UCP-1 protein content

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

Mean adipocyte size

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

Trial details

NCT IDNCT06878989

SponsorUniversidad de Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

View on ClinicalTrials.gov More Obesity and Overweight trials

Plain-language summary

Who can participate

Age range

18 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

BAT volume

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

BAT 18F-FDG uptake upon cold exposure

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

BAT UCP-1 protein content

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).

Mean adipocyte size

Timeframe: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).