Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06878989

Adaptation of Human Brown Adipose Tissue to Calorie Restriction

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Granada, 18007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Maintenance Diet

Behavioral

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

Primary outcomes

  1. BAT volume

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

  2. BAT 18F-FDG uptake upon cold exposure

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

  3. BAT UCP-1 protein content

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

  4. Mean adipocyte size

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

Secondary outcomes

  1. BAT transcriptomics (RNA sequencing)

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

  2. Weight (kg)

    Time frame: 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

  3. Waist circumference (cm)

    Time frame: 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

  4. Hip circumference (cm)

    Time frame: 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

  5. Resting Systolic blood pressure (mmHg)

    Time frame: 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

  6. Resting Diastolic blood pressure (mmHg)

    Time frame: 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

  7. Fat mass (kg) by DXA

    Time frame: 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

  8. Fat free mass (kg) by DXA

    Time frame: 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

  9. Fat mass (kg) by Bioimpedanciometry

    Time frame: 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

  10. Fat free mass (kg) by Bioimpedanciometry

    Time frame: 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

  11. Body Mass Index (kg/m2)

    Time frame: 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

  12. Resting Energy Expenditure (kcal/day) measured by indirect calorimetry

    Time frame: 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

  13. Ad libitum energy intake (kcal) measured in a test meal

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

  14. Meal-induced thermogenesis (% of resting energy expenditure) measured by indirect calorimetry

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

  15. Resting heart rate variability

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

    RMSSD, SDNN

  16. Maximal fat oxidation (g/min) by indirect calorimetry

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

  17. Physical activity (counts) measured by accelerometry

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

  18. Sedentary time (min) measured by accelerometry

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

  19. Habitual food consumption collected by a food frequency questionnaire

    Time frame: 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

  20. Serum total cholesterol (mg/dl)

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

  21. Serum C-reactive protein (mg/l)

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

  22. Serum thyrotropin (µU/mL)

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

  23. Serum alanine aminotransferase (U/L)

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

  24. Serum aspartate aminotransferase (U/L)

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

  25. Serum gamma-glutamyl transferase (U/L)

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

  26. Serum triglycerides (mg/dl)

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

  27. Serum LDL cholesterol (mg/dL)

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

  28. Serum HDL cholesterol (mg/dl)

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

  29. Serum glucose (mg/dl)

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

  30. Serum insulin (U/ml)

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

  31. Serum hemoglobin A1c (mmol/mol)

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

  32. Serum triiodothyronine (ng/dL)

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

  33. Serum thyroxine (ng/dL)

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

  34. Sleep time (min) measured by accelerometry

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

  35. Handgrip strength (kg) measured using a dynamometer

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

  36. Meal-induced changes in insulin concentration (U/ml) in response to a standardized meal

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

  37. Meal-induced changes in glucose concentration (mmol/L) in response to a standardized meal

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

  38. Meal-induced changes in lactate concentrations (mmol/l) in response to a standardized meal

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

  39. Meal-induced changes in triglycerides concentrations (mg/dl) in response to a standardized meal

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

  40. Meal-induced changes in total cholesterol concentrations (mg/dL) in response to a standardized meal

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

  41. Meal-induced changes in free fatty acids (mmol/L) in response to a standardized meal

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

  42. Meal-induced changes in glycerol concentrations (mmol/l) in response to a standardized meal

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

  43. Meal-induced changes in 3-hydroxybutyrate concentrations (mmol/L) in response to a standardized meal

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

  44. Functional mobility measured by "Timed Up and Go (TUG)" test

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

  45. Walking speed (m/s) measured by a gait speed test

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

  46. Independence in activities of daily living (ADL) measured by "Barthel Index"

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

  47. Food cravings measured using the "Food Craving Inventory" questionnaire

    Time frame: 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

  48. Control of eating behavior measured using the "Control of Eating Weekly Questionnaire"

    Time frame: 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

  49. Cognitive restriction of food intake measured using the "Three-Factor Eating Questionnaire"

    Time frame: 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

  50. Food disinhibition measured using the "Three-Factor Eating Questionnaire"

    Time frame: 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

  51. Subjective hunger measured using the "Three-Factor Eating Questionnaire"

    Time frame: 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

  52. Binge eating behavior measured using the "Binge Eating Questionnaire"

    Time frame: 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

  53. Fasting appetite-related sensations measured using "Visual Analogue Scales (VAS)"

    Time frame: 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

    The scales range from 0 to 100

  54. Meal-induced changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a standardized meal

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

    The scales range from 0 to 100

  55. Energy efficiency (W/Kcal) while cycling, assessed by indirect calorimetry

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

  56. Vastus lateralis thickness (cm) measured by ultrasound

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

  57. Subcutaneous fat thickness (cm) measured by ultrasound

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

  58. Superficial fat thickness (cm) measured by ultrasound

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

  59. Preperitoneal fat thickness (cm) measured by ultrasound

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

  60. Carbohydrate intake (g/day) collected through three 24-hour recalls

    Time frame: 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

  61. Fat intake (g/day) collected through three 24-hour recalls

    Time frame: 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

  62. Protein intake (g/day) collected through three 24-hour recalls

    Time frame: 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

  63. Fiber intake (g/day) collected through three 24-hour recalls

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Hospital Clinico Universitario San Cecilio
  • University Hospital Virgen de las Nieves

Registry information

Official study title

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

Acronym: BATON

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.