Obesity and OverweightBATONNCT06878989
Adaptation of Human Brown Adipose Tissue to Calorie Restriction
A study testing Caloric restriction diet and Weight maintenance diet in people with Obesity and Overweight, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Caloric restriction diet and Weight maintenance diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 25 Jan 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Physiology, Faculty of Medicine, University of Granada.
Granada, Granada, 18007
About this study
Official title: Adaptation of Human Brown Adipose Tissue to Calorie Restriction (BATON)
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
- Being tested
- Caloric restriction diet, Weight maintenance diet
- Keywords
- Energy metabolism, Metabolic Health, Brown adipose tissue (BAT), Thermogenesis, Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restriction dietBehavioural
Dietary intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period.
Weight maintenance dietBehavioural
Dietary intervention consisting on a meal plan designed to maintain a stable body weight for up to 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss group | Experimental | Not described Receives: Behavioral: Caloric restriction diet |
| Control group | Experimental | Not described Receives: Behavioral: Weight maintenance diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
BAT volume
Measured: 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
Measured: 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
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Mean adipocyte size
Measured: 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)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Weight (kg)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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 Bioimpedanciometry
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Meal-induced thermogenesis (% of resting energy expenditure) measured by indirect calorimetry
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Resting heart rate variability
RMSSD, SDNN
Measured: 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
Measured: 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
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Sedentary time (min) measured by accelerometry
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Serum thyrotropin (µU/mL)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Serum triglycerides (mg/dl)
Measured: 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)
Measured: 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)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Serum glucose (mg/dl)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Serum insulin (U/ml)
Measured: 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)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Serum triiodothyronine (ng/dL)
Measured: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
Serum thyroxine (ng/dL)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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"
Measured: 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
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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"
Measured: 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)"
The scales range from 0 to 100
Measured: 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
The scales range from 0 to 100
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start25 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
- Responsible party
- Principal investigator, Guillermo Sanchez Delgado, Universidad de Granada
- Investigators
- Guillermo Sanchez Delgado, Ramon y Cajal Researcher, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878989
- Sponsor's protocol ID
- GSD-2024-004
- Other IDs
- PID2021-127582OA-I00
- Acronym
- BATON
- Status last verified
- May 2026
- First submitted
- 12 Feb 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Human Brown Adipose Tissue to Calorie Restriction (BATON)
- ClinicalTrials.gov ID
- NCT06878989
- Acronym / sponsor ID
- BATON / GSD-2024-004
- Conditions
- Obesity and Overweight
- Keywords
- Energy metabolism, Metabolic Health, Brown adipose tissue (BAT), Thermogenesis, Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss group | Experimental | Behavioral: Caloric restriction diet |
| Control group | Experimental | Behavioral: Weight maintenance diet |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric restriction dietDietary intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period. | Behavioural | Weight loss group |
| Weight maintenance dietDietary intervention consisting on a meal plan designed to maintain a stable body weight for up to 16 weeks. | Behavioural | Control group |
Primary outcome
BAT volume
Time frame: 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
Time frame: 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
Time frame: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).
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).
63 secondary outcomes
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).
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
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
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
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
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
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
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
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
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
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
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
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).
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).
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).
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).
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).
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).
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
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Sanchez Delgado, Ramon y Cajal Researcher principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction diet and Weight maintenance diet in people with Obesity and Overweight, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BAT volume (time frame: Baseline; End of the dietary intervention (Week 12/16, depending on when the participant achieves an 8-10% weight loss).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.