Understanding how brown fat responds to calorie restriction in obese young adults

Adaptation of Human Brown Adipose Tissue to Calorie Restriction (BATON)

This study tests how a calorie-restricted diet affects brown fat in young adults with obesity to see if it can help with weight loss and improve metabolism.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 30 Years
• Sex: All
• Sponsor: Universidad de Granada (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Granada)
• Trial ID: NCT06878989 on ClinicalTrials.gov

What this trial studies

The BATON study explores the adaptation of human brown adipose tissue (BAT) to a controlled caloric restriction diet in young adults with obesity. Participants will be divided into two groups: one following a diet aimed at achieving an 8-10% weight loss over 12-16 weeks, and another on a weight maintenance diet. Advanced technologies, including PET-CT and molecular analyses, will be utilized to assess the outcomes and understand the role of BAT in body weight regulation. This study aims to provide insights into energy metabolism and metabolic health in the context of obesity.

Who should consider this trial

Good fit: Ideal candidates are young adults with a BMI of 27-40 kg/m² and a body fat percentage exceeding 25% in men and 30% in women.

Not a fit: Patients with significant medical conditions or those unable to comply with dietary interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dietary strategies for weight management and metabolic health in obese individuals.

How similar studies have performed: Other studies have shown promising results in understanding the role of brown adipose tissue in metabolism, suggesting potential for success in this approach.

Eligibility criteria

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 research team, could alter energy metabolism or digestive function during the course of the study.
* Having been exposed to medical procedures involving an estimated radiation dose exceeding 5 mSv in the past 5 years or 10 mSv over a lifetime.
* Use of medications or supplements that are known to alter body weight or appetite.
* Weight loss exceeding 10% in the past two years or more than 5% in the past six months, unless completed weight recovery has occurred.
* Adherence to unconventional dietary patterns, such as vegan or fasting diets, or inability to tolerate the foods provided during the study.
* Pregnancy, plans to become pregnant within the next two years, postpartum period (within 12 months after delivery), or lactation.
* Perimenopausal status, defined as the presence of irregular menstrual cycles, hormonal changes indicative of perimenopause, or menopausal symptoms.
* Participation in any type of nutritional intervention or treatment within the past three months.
* Diagnosis or risk factors for the development of an eating disorder.
* Frequent disruptions in the sleep-wake cycle.
* Clinically significant abnormalities in gastric emptying, current diagnosis of any form of diabetes, blood pressure exceeding 160/90 mmHg, or resting heart rate below 50 or above 100 beats per minute (while seated), regardless of stable antihypertensive medication use.
* Active or untreated malignant disease or remission from a clinically significant malignant disease for less than five years prior to the evaluation.
* History of drug or alcohol abuse or a positive drug test, unless due to a medication prescribed by a healthcare professional.
* Smoking, vaping, or habitual use of tobacco products, unless abstinent for at least 72 consecutive hours during the past four weeks.
* Habitual caffeine consumption exceeding the equivalent of three espresso coffees per day (225 mg/day).
* Being a direct relative or household member of the research team personnel.
* Any other condition that, in the opinion of the research team, contraindicates study participation.

Where this trial is running

Granada

• Instituto Mixto Universitario Deporte y Salud — Granada, Spain (Recruiting)

Study contacts

• Principal investigator: Postdoctoral Researcher — Universidad de Granada
• Study coordinator: Guillermo Sanchez Delgado Postdoctoral Researcher

Conditions Obesity and Overweight; Energy metabolism; Metabolic Health; Brown adipose tissue; Thermogenesis; Obesity