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临床试验/NCT06878989
NCT06878989进行中（未招募）不适用

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

Universidad de Granada1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月25日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
30
试验地点
1
主要终点
BAT volume
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Weight loss group

Experimental

干预措施: Caloric restriction diet (Behavioral)

Control group

Experimental

干预措施: Weight maintenance diet (Behavioral)

结局指标

主要结局

BAT volume

时间窗: 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

时间窗: 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

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

Mean adipocyte size

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

次要结局

  • Meal-induced thermogenesis (% of resting energy expenditure) measured by indirect calorimetry(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Resting heart rate variability(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Maximal fat oxidation (g/min) by indirect calorimetry(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Physical activity (counts) measured by accelerometry(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • BAT transcriptomics (RNA sequencing)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • 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 Diastolic 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)
  • Fat mass (kg) by DXA(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)
  • Fat free mass (kg) by DXA(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)
  • 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)
  • 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)
  • 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)
  • Ad libitum energy intake (kcal) measured in a test meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Fat mass (kg) by Bioimpedanciometry(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)
  • Fat free mass (kg) by Bioimpedanciometry(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)
  • Body Mass Index (kg/m2)(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 Energy Expenditure (kcal/day) measured by indirect calorimetry(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)
  • Sedentary time (min) measured by accelerometry(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Habitual food consumption collected by a food frequency questionnaire(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)
  • Serum total cholesterol (mg/dl)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum aspartate aminotransferase (U/L)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum gamma-glutamyl transferase (U/L)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum C-reactive protein (mg/l)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum thyrotropin (µU/mL)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum alanine aminotransferase (U/L)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum LDL cholesterol (mg/dL)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum triglycerides (mg/dl)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum HDL cholesterol (mg/dl)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum glucose (mg/dl)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum insulin (U/ml)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum hemoglobin A1c (mmol/mol)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum triiodothyronine (ng/dL)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Serum thyroxine (ng/dL)(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Sleep time (min) measured by accelerometry(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Handgrip strength (kg) measured using a dynamometer(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in insulin concentration (U/ml) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in glucose concentration (mmol/L) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in lactate concentrations (mmol/l) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in triglycerides concentrations (mg/dl) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in total cholesterol concentrations (mg/dL) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in free fatty acids (mmol/L) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in glycerol concentrations (mmol/l) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Meal-induced changes in 3-hydroxybutyrate concentrations (mmol/L) in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Functional mobility measured by "Timed Up and Go (TUG)" test(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Walking speed (m/s) measured by a gait speed test(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Independence in activities of daily living (ADL) measured by "Barthel Index"(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Food cravings measured using the "Food Craving Inventory" questionnaire(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)
  • Control of eating behavior measured using the "Control of Eating Weekly Questionnaire"(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)
  • Cognitive restriction of food intake measured using the "Three-Factor Eating Questionnaire"(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)
  • Food disinhibition measured using the "Three-Factor Eating Questionnaire"(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)
  • Subjective hunger measured using the "Three-Factor Eating Questionnaire"(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)
  • Binge eating behavior measured using the "Binge Eating Questionnaire"(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)
  • Fasting appetite-related sensations measured using "Visual Analogue Scales (VAS)"(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)
  • Meal-induced changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a standardized meal(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Energy efficiency (W/Kcal) while cycling, assessed by indirect calorimetry(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Vastus lateralis thickness (cm) measured by ultrasound(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Subcutaneous fat thickness (cm) measured by ultrasound(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Superficial fat thickness (cm) measured by ultrasound(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Preperitoneal fat thickness (cm) measured by ultrasound(Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).)
  • Carbohydrate intake (g/day) collected through three 24-hour recalls(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)
  • Fat intake (g/day) collected through three 24-hour recalls(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)
  • Protein intake (g/day) collected through three 24-hour recalls(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)
  • Fiber intake (g/day) collected through three 24-hour recalls(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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Sanchez Delgado

Ramon y Cajal Researcher

Universidad de Granada

研究点 (1)

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