Adaptation of Human Brown Adipose Tissue to Calorie Restriction

NCT ID: NCT06878989

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Obesity and Overweight

Keywords

Energy metabolism; Metabolic Health; Brown adipose tissue (BAT); Thermogenesis; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Weight loss group

Group Type: EXPERIMENTAL

Caloric restriction diet

Intervention Type: BEHAVIORAL

Dietary intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period.

Control group

Group Type: EXPERIMENTAL

Weight maintenance diet

Intervention Type: BEHAVIORAL

Dietary intervention consisting on a meal plan designed to maintain a stable body weight for up to 16 weeks.

Interventions

Caloric restriction diet

Dietary intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period.

Intervention Type: BEHAVIORAL

Weight maintenance diet

Dietary intervention consisting on a meal plan designed to maintain a stable body weight for up to 16 weeks.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinico Universitario San Cecilio

OTHER

Sponsor Role: collaborator

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Sanchez Delgado

Ramon y Cajal Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo Sanchez Delgado, Ramon y Cajal Researcher

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Department of Physiology, Faculty of Medicine, University of Granada.

Granada, Granada, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Guillermo Sanchez-Delgado

Role: CONTACT

Phone: +34 958241574

Email: gsanchezdelgado@ugr.es

Facility Contacts

Guillermo Sanchez Delgado, PhD

Role: primary

Other Identifiers

PID2021-127582OA-I00

Identifier Type: OTHER

Identifier Source: secondary_id

GSD-2024-004

Identifier Type: -

Identifier Source: org_study_id