Adaptation of Human Brown Adipose Tissue to Calorie Restriction

NCT06878989 | Recruiting

• 2 other identifiers: GSD-2024-004PID2021-127582OA-I00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• BAT volume

  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

  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

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

• Mean adipocyte size

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

Secondary Outcomes (63)

• BAT transcriptomics (RNA sequencing)

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

• Weight (kg)

  Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention

• Waist circumference (cm)

  Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention

• Hip circumference (cm)

  Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention

• Resting Systolic blood pressure (mmHg)

  Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss); 6 months after the end of dietary intervention; 12 months after the end of dietary intervention

Study Arms (2)

Weight loss group

EXPERIMENTAL

Behavioral: Caloric restriction diet

Control group

EXPERIMENTAL

Behavioral: Weight maintenance diet

Interventions

Caloric restriction diet BEHAVIORAL

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

Weight loss group

Weight maintenance diet BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead
• Hospital Clinico Universitario San Cecilio: collaborator
• University Hospital Virgen de las Nieves: collaborator

Study Sites (1)

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

Granada, Granada, 18007, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Guillermo Sanchez Delgado, Ramon y Cajal Researcher

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillermo Sanchez-Delgado

CONTACT

+34 958241574; gsanchezdelgado@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ramon y Cajal Researcher

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 17, 2025
• Study Start: January 25, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2025-12

Locations

ES (1)