ObesityNCT04385615
Fasting Mimicking Diet and Beige/Brown Adipose Tissue in Humans
A study testing Fasting Mimicking Diet in people with Obesity, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Obesity today has become one of the main public health concerns. As a consequence, different strategies have arisen to fight weight gain. One of the alternative strategies to increase the success of therapeutic approaches to weight loss is the increase in energy expenditure, through thermogenesis, regulated by the… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Fasting Mimicking Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥ 25 and < 30kg/m2.
Who cannot join
- Residing outside of Campinas county;
- Pregnant or lactating women;
- Patients with severe, non-stabilized neurological or psychiatric problems;
- Use of anti-obesity or lipid-lowering medication;
- Use of adrenergic or benzodiazepine drugs;
- Use of illicit drugs;
Show all 10Show fewer
- Individuals with neoplasms, transmissible diseases, rheumatic disease, hepatic or renal insufficiency, non-treated thyroid dysfunction, diabetes mellitus, cardiovascular disease, history of fainting, active infection;
- Individuals who are allergic to nuts, soybean, oats, sesame or celery;
- Individuals who have had a change of more than 5% of their body weight in the last six months;
- Individuals who are carrying some kind of diet or modification to their habitual eating habits.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medical Sciences - University of Campinas
Campinas, São Paulo, 13083-887
About this study
Official title: Effect of Fasting Mimicking Diet on the Activation of Beige/Brown Adipose Tissue in Humans
Obesity today has become one of the main public health concerns. As a consequence, different strategies have arisen to fight weight gain. One of the alternative strategies to increase the success of therapeutic approaches to weight loss is the increase in energy expenditure, through thermogenesis, regulated by the beige/brown adipose tissue (BAT). Studies have shown that beige/BAT has a strong correlation with body weight regulation. It has also been demonstrated that cold exposure activates beige/BAT. Recent studies, mainly in animal models, suggest that beige/BAT can also be activated by specific food and nutrients. Concomitantly, new dietary interventions, to treat obesity, have also been studied. One of these dietary interventions is the Fasting Mimicking Diet (FMD). Since FMD is high in unsaturated fat, and clinical trials have shown that FMD interventions reduced body weight and improved metabolic health, there is a possible association between this diet and the activation of beige/BAT. The aim of this is study is to investigate the effect of Fasting Mimicking Diet on the activation of beige/brown adipose tissue, in humans with overweight. This will be an open clinical trial with the duration of three consecutive months (three cycles of the FMD diet). There will be an FMD and a control group. The following data will be collected before and after the intervention, for each group: dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation (Positron Emission Tomography - PET with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with computed tomography - PET/CT scan, Thermal Imaging, BAT adipokines and genes related to BAT activity), basal metabolic rates and caloric needs (Indirect Calorimetry), anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. Data will be expressed as mean and standard deviation and the variables will be compared by Student's t-test or ANOVA, for repeated measures.
Read the detailed description
HYPOTHESIS
Beige/BAT has been shown as a promising strategy to treat obesity. The exact mechanism, and stimulus, of activation of this tissue have not been completely clarified. However, some studies have identified some nutrients, such as unsaturated fat, as a potential stimulus for activation. The effect of Fasting Mimicking Diet on the activation of Beige/Brown Adipose Tissue has not yet been investigated. Since FMD is high in unsaturated fat, and clinical trials have shown that FMD interventions reduced body weight and improved metabolic health, there is a possible association between this diet and the activation of beige/BAT.
Our hypothesis is that an intervention, with a 5-days cycle for 3 consecutive months, of Fasting Mimicking Diet will promote beige/brown adipose tissue activation and will improve body weight and metabolic markers related to obesity, in humans with overweight.
OBJECTIVES
Main Objective
To evaluate the effect of a dietary intervention using 3 cycles of Fasting Mimicking Diet on the activation of beige/brown adipose tissue, in humans with overweight.
Specific Objectives
- To evaluate the effect of the FMD on the activation of Beige/Brown Adipose Tissue using PET/CT (FDG-18) and Thermal Imaging (FLIR camera);
- To evaluate anthropometric measures (weight, abdomen circumference) and body composition (DEXA scan), before, during and after the FMD intervention;
- To evaluate basal metabolic rates and daily caloric needs (Indirect Calorimetry), before and after the FMD intervention;
- To evaluate the effect of the FMD on metabolic markers and hormones: leptin (ELISA), insulin (ELISA), glucose, total cholesterol, LDL, HDL and triglycerides;
- To evaluate the effect of the FMD on insulin sensitivity (using OGIS);
- To evaluate the effect of the FMD on cytokines: tumor necrosis factor alpha (TNF-α), interleukin 1-beta (IL1β), Monocyte Chemoattractant Protein-1 (MCP1), interleukin-6 (IL-6) and interleukin-10 (IL-10) (ELISA);
- To evaluate the effect of the FMD on Brown Adipose Tissue Adipokines: insulin-like growth factor 1 (IGF-1), IL-6, fibroblast growth factor 21 (FGF21) and 12,13-dihydroxy-9z-octadecenoic acid (12,13-diHOME) (ELISA);
- To evaluate the effect of the FMD on BAT activation genes: peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) and G-protein coupled receptor 120 (GPR120) (PCR).
MATERIALS AND METHODS
Selection of Participants
The estimated sample size is 26 individuals. Participants will be overweight. There will be a control group (n=13) and an FMD group (n=13). There will be similar sample size for both genders. Participants will be recruited through electronic and printed media propagation.
Design
This will be an open clinical trial with the duration of three consecutive months (three cycles). There will be data collection before, during and after the dietary intervention. In this intervention, participants will be requested either to follow three cycles of a Fasting Mimicking Diet, or to follow their habitual eating habits for three months (control group). For the FMD group, participants will receive the FMD diet and will be requested to follow the recommendations from the manufacturer: FMD diet for 5 consecutive days (during these days, they will be asked to only eat the FMD diet), and for the remaining 25 days of the month, participants should continue with their habitual eating habits. This procedure will be repeated three times.
The FMD diet will be provided by L-Nutra, Nutrition for Longevity (commercial name of the diet: ProLon). All the data will be collected at University of Campinas, Brazil. More specifically, the Indirect Calorimetry and the DEXA scan will be done at the LIMED (Laboratory of Investigation of Metabolism and Diabetes) and the PET/CT (FDG-18) will be done at the Center of Nuclear Medicine in the Hospital de Clínicas (HC) Hospital.
The following data will be collected from both groups (control and FMD):
- Evaluation of food consumption: 24hr-Food Recall - before, during and after the intervention;
- Evaluation of physical activity: short version of the International Physical Activity Questionnaire IPAQ) - before and after the intervention;
- Evaluation of beige/BAT activity:
- Positron Emission Tomography (PET) with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with computed tomography (PET/CT scan) - before and after the intervention:
- Individualized cooling protocol: For this exam, participants will be allocated in a room with a controlled temperature (19oC). They will be using light cloths and a cooling vest (commercial name: Polar), for one hour. Right after, they will receive 4.0 megabecquerel/kg (MBq/kg) of 18F-FDG and will continue in the room, with a controlled temperature (19oC), for another hour. After these two hours they will move to the PET/CT room;
- Thermal Imaging (FLIR camera) - before, during and after the intervention:
- Individualized cooling protocol: For this exam, participants will be allocated in a room with a controlled temperature (19oC). They will be using light cloths and a cooling vest (commercial name: Polar), for two hours;
- Brown Adipose Tissue Adipokines: IGF-1, IL-6, FGF21 and 12,13-diHOME, using ELISA;
- Brown Adipose Tissue activation genes: PGC-1α and GPR120, using PCR;
- Evaluation of basal metabolic rates and caloric needs: Indirect Calorimetry (gas exchange analysis: oxygen (O2) consumption and carbon dioxide (CO2) release) - before and after the intervention;
- Evaluation of anthropometric measures - before, during and after the intervention:
- Weight (digital scale) and height (fixed stadiometer);
- Abdominal circumference;
- Body composition: Dual-energy X-ray absorptiometry (DEXA scan);
- Blood samples - before, during and after the intervention:
- Cytokines (TNF-α, IL1β, MCP1, IL-6 and IL-10) and hormones (insulin and leptin) - Enzyme-linked immunosorbent assay (ELISA);
- Metabolic markers (glucose, total cholesterol, LDL, HDL and triglycerides);
- Insulin sensitivity - OGIS (Oral Glucose Insulin Sensitivity). This measurement is calculated using insulin and glucose values.
Statistical Analysis
Data will be expressed as mean and standard deviation and the variables will be compared by Student's t-test or ANOVA, for repeated measures.
- Conditions
- Obesity
- Being tested
- Fasting Mimicking Diet
- Keywords
- Obesity, Fasting Mimicking Diet (FMD), Brown Adipose Tissue (BAT)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking DietOther
Participants will be requested to follow three cycles (of 5 day each), for three consecutive months, of a Fasting Mimicking Diet, a plant-based, low-calorie, low-protein, low-carbohydrate, high-unsaturated fat diet. For the remaining 25 days of each month, participants should continue with their habitual eating habits.
| Study group | Role | What they receive |
|---|---|---|
| FMD Group | Experimental | Participants will be requested to follow a Fasting Mimicking Diet, for three consecutive months. Before and after the intervention dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation, anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. Receives: Other: Fasting Mimicking Diet |
| Control Group | No intervention | Participants will be requested to continue with their habitual eating habits, for three consecutive months. Before and after the intervention dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation, anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of beige/brown adipose tissue - Volume
Changes from baseline maximum Standardized Uptake Values (SUVmax) and mean Standardized Uptake Values (SUVmean), as assessed by PET/CT (FDG-18).
Measured: Three months
Activation of beige/brown adipose tissue - Temperature
Changes from baseline BAT temperature, as assessed by Thermal Imaging.
Measured: Three months
Activation of beige/brown adipose tissue - Adipokines
Changes from baseline BAT adipokines, as assessed by ELISA.
Measured: Three months
Activation of beige/brown adipose tissue - Activation Genes
Changes from baseline BAT activation genes, as assessed by PCR.
Measured: Three months
Secondary outcomes (5)
Basal metabolic rates (BMR)
Changes from baseline BMR, as assessed by Indirect Calorimetry.
Measured: Three months
Metabolic markers
Changes from baseline LDL, HDL, total cholesterol, triglycerides and glucose levels (mg/dL).
Measured: Three months
Hormones
Changes from baseline insulin and leptin levels, as assessed by ELISA.
Measured: Three months
Inflammatory markers
Changes from baseline inflammatory cytokines (TNF-α, IL1β, MCP1, IL-6 and IL-10), as assessed by ELISA.
Measured: Three months
Insulin Sensitivity
Changes from baseline insulin sensitivity, as assessed by OGIS (insulin and glucose levels will be combined to report insulin sensitivity in ml minˆ-1 mˆ-2).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study startFeb 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Due to the pandemic, we had no participants enrolled. After the end of the pandemic, for reasons related to time and financial support the study had to be cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group will receive the FMD diet. The other group will be the control.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Reymond Simoes, University of Campinas, Brazil
- Investigators
- Marcela R Simoes, MS Candidate, Principal investigator, University of CampinasLicio A Velloso, Professor, Study director, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385615
- Sponsor's protocol ID
- CAAE: 20037719.0.0000.5404
- Status last verified
- May 2026
- First submitted
- 4 May 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carpentier AC, Blondin DP, Virtanen KA, Richard D, Haman F, Turcotte EE. Brown Adipose Tissue Energy Metabolism in Humans. Front Endocrinol (Lausanne). 2018 Aug 7;9:447. doi: 10.3389/fendo.2018.00447. eCollection 2018.
PubMed 30131768Leitner BP, Huang S, Brychta RJ, Duckworth CJ, Baskin AS, McGehee S, Tal I, Dieckmann W, Gupta G, Kolodny GM, Pacak K, Herscovitch P, Cypess AM, Chen KY. Mapping of human brown adipose tissue in lean and obese young men. Proc Natl Acad Sci U S A. 2017 Aug 8;114(32):8649-8654. doi: 10.1073/pnas.1705287114. Epub 2017 Jul 24.
PubMed 28739898Rachid B, van de Sande-Lee S, Rodovalho S, Folli F, Beltramini GC, Morari J, Amorim BJ, Pedro T, Ramalho AF, Bombassaro B, Tincani AJ, Chaim E, Pareja JC, Geloneze B, Ramos CD, Cendes F, Saad MJ, Velloso LA. Distinct regulation of hypothalamic and brown/beige adipose tissue activities in human obesity. Int J Obes (Lond). 2015 Oct;39(10):1515-22. doi: 10.1038/ijo.2015.94. Epub 2015 May 21.
PubMed 25994805
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Mimicking Diet on the Activation of Beige/Brown Adipose Tissue in Humans
- ClinicalTrials.gov ID
- NCT04385615
- Acronym / sponsor ID
- CAAE: 20037719.0.0000.5404
- Conditions
- Obesity
- Keywords
- Obesity, Fasting Mimicking Diet (FMD), Brown Adipose Tissue (BAT)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the pandemic, we had no participants enrolled. After the end of the pandemic, for reasons related to time and financial support the study had to be cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 13 May 2020 (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.
Obesity today has become one of the main public health concerns. As a consequence, different strategies have arisen to fight weight gain. One of the alternative strategies to increase the success of therapeutic approaches to weight loss is the increase in energy expenditure, through thermogenesis, regulated by the beige/brown adipose tissue (BAT). Studies have shown that beige/BAT has a strong correlation with body weight regulation. It has also been demonstrated that cold exposure activates beige/BAT. Recent studies, mainly in animal models, suggest that beige/BAT can also be activated by specific food and nutrients. Concomitantly, new dietary interventions, to treat obesity, have also been studied. One of these dietary interventions is the Fasting Mimicking Diet (FMD). Since FMD is high in unsaturated fat, and clinical trials have shown that FMD interventions reduced body weight and improved metabolic health, there is a possible association between this diet and the activation of beige/BAT. The aim of this is study is to investigate the effect of Fasting Mimicking Diet on the activation of beige/brown adipose tissue, in humans with overweight. This will be an open clinical trial with the duration of three consecutive months (three cycles of the FMD diet). There will be an FMD and a control group. The following data will be collected before and after the intervention, for each group: dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation (Positron Emission Tomography - PET with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with computed tomography - PET/CT scan, Thermal Imaging, BAT adipokines and genes related to BAT activity), basal metabolic rates and caloric needs (Indirect Calorimetry), anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. Data will be expressed as mean and standard deviation and the variables will be compared by Student's t-test or ANOVA, for repeated measures.
Detailed description
HYPOTHESIS
Beige/BAT has been shown as a promising strategy to treat obesity. The exact mechanism, and stimulus, of activation of this tissue have not been completely clarified. However, some studies have identified some nutrients, such as unsaturated fat, as a potential stimulus for activation. The effect of Fasting Mimicking Diet on the activation of Beige/Brown Adipose Tissue has not yet been investigated. Since FMD is high in unsaturated fat, and clinical trials have shown that FMD interventions reduced body weight and improved metabolic health, there is a possible association between this diet and the activation of beige/BAT.
Our hypothesis is that an intervention, with a 5-days cycle for 3 consecutive months, of Fasting Mimicking Diet will promote beige/brown adipose tissue activation and will improve body weight and metabolic markers related to obesity, in humans with overweight.
OBJECTIVES
Main Objective
To evaluate the effect of a dietary intervention using 3 cycles of Fasting Mimicking Diet on the activation of beige/brown adipose tissue, in humans with overweight.
Specific Objectives
- To evaluate the effect of the FMD on the activation of Beige/Brown Adipose Tissue using PET/CT (FDG-18) and Thermal Imaging (FLIR camera);
- To evaluate anthropometric measures (weight, abdomen circumference) and body composition (DEXA scan), before, during and after the FMD intervention;
- To evaluate basal metabolic rates and daily caloric needs (Indirect Calorimetry), before and after the FMD intervention;
- To evaluate the effect of the FMD on metabolic markers and hormones: leptin (ELISA), insulin (ELISA), glucose, total cholesterol, LDL, HDL and triglycerides;
- To evaluate the effect of the FMD on insulin sensitivity (using OGIS);
- To evaluate the effect of the FMD on cytokines: tumor necrosis factor alpha (TNF-α), interleukin 1-beta (IL1β), Monocyte Chemoattractant Protein-1 (MCP1), interleukin-6 (IL-6) and interleukin-10 (IL-10) (ELISA);
- To evaluate the effect of the FMD on Brown Adipose Tissue Adipokines: insulin-like growth factor 1 (IGF-1), IL-6, fibroblast growth factor 21 (FGF21) and 12,13-dihydroxy-9z-octadecenoic acid (12,13-diHOME) (ELISA);
- To evaluate the effect of the FMD on BAT activation genes: peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) and G-protein coupled receptor 120 (GPR120) (PCR).
MATERIALS AND METHODS
Selection of Participants
The estimated sample size is 26 individuals. Participants will be overweight. There will be a control group (n=13) and an FMD group (n=13). There will be similar sample size for both genders. Participants will be recruited through electronic and printed media propagation.
Design
This will be an open clinical trial with the duration of three consecutive months (three cycles). There will be data collection before, during and after the dietary intervention. In this intervention, participants will be requested either to follow three cycles of a Fasting Mimicking Diet, or to follow their habitual eating habits for three months (control group). For the FMD group, participants will receive the FMD diet and will be requested to follow the recommendations from the manufacturer: FMD diet for 5 consecutive days (during these days, they will be asked to only eat the FMD diet), and for the remaining 25 days of the month, participants should continue with their habitual eating habits. This procedure will be repeated three times.
The FMD diet will be provided by L-Nutra, Nutrition for Longevity (commercial name of the diet: ProLon). All the data will be collected at University of Campinas, Brazil. More specifically, the Indirect Calorimetry and the DEXA scan will be done at the LIMED (Laboratory of Investigation of Metabolism and Diabetes) and the PET/CT (FDG-18) will be done at the Center of Nuclear Medicine in the Hospital de Clínicas (HC) Hospital.
The following data will be collected from both groups (control and FMD):
- Evaluation of food consumption: 24hr-Food Recall - before, during and after the intervention;
- Evaluation of physical activity: short version of the International Physical Activity Questionnaire IPAQ) - before and after the intervention;
- Evaluation of beige/BAT activity:
- Positron Emission Tomography (PET) with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with computed tomography (PET/CT scan) - before and after the intervention:
- Individualized cooling protocol: For this exam, participants will be allocated in a room with a controlled temperature (19oC). They will be using light cloths and a cooling vest (commercial name: Polar), for one hour. Right after, they will receive 4.0 megabecquerel/kg (MBq/kg) of 18F-FDG and will continue in the room, with a controlled temperature (19oC), for another hour. After these two hours they will move to the PET/CT room;
- Thermal Imaging (FLIR camera) - before, during and after the intervention:
- Individualized cooling protocol: For this exam, participants will be allocated in a room with a controlled temperature (19oC). They will be using light cloths and a cooling vest (commercial name: Polar), for two hours;
- Brown Adipose Tissue Adipokines: IGF-1, IL-6, FGF21 and 12,13-diHOME, using ELISA;
- Brown Adipose Tissue activation genes: PGC-1α and GPR120, using PCR;
- Evaluation of basal metabolic rates and caloric needs: Indirect Calorimetry (gas exchange analysis: oxygen (O2) consumption and carbon dioxide (CO2) release) - before and after the intervention;
- Evaluation of anthropometric measures - before, during and after the intervention:
- Weight (digital scale) and height (fixed stadiometer);
- Abdominal circumference;
- Body composition: Dual-energy X-ray absorptiometry (DEXA scan);
- Blood samples - before, during and after the intervention:
- Cytokines (TNF-α, IL1β, MCP1, IL-6 and IL-10) and hormones (insulin and leptin) - Enzyme-linked immunosorbent assay (ELISA);
- Metabolic markers (glucose, total cholesterol, LDL, HDL and triglycerides);
- Insulin sensitivity - OGIS (Oral Glucose Insulin Sensitivity). This measurement is calculated using insulin and glucose values.
Statistical Analysis
Data will be expressed as mean and standard deviation and the variables will be compared by Student's t-test or ANOVA, for repeated measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group will receive the FMD diet. The other group will be the control.
| Arm | Type | Receives |
|---|---|---|
| FMD Group | Experimental | Other: Fasting Mimicking DietParticipants will be requested to follow a Fasting Mimicking Diet, for three consecutive months. Before and after the intervention dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation, anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. |
| Control Group | No intervention | –Participants will be requested to continue with their habitual eating habits, for three consecutive months. Before and after the intervention dietary intake and physical activity data, evaluation of beige/brown adipose tissue activation, anthropometric measures and body composition (DEXA scan), lipid profile and inflammatory markers. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index (BMI) ≥ 25 and < 30kg/m2.
Key exclusion criteria (10 listed)
- Residing outside of Campinas county;
- Pregnant or lactating women;
- Patients with severe, non-stabilized neurological or psychiatric problems;
- Use of anti-obesity or lipid-lowering medication;
- Use of adrenergic or benzodiazepine drugs;
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 |
|---|---|---|
| Fasting Mimicking DietParticipants will be requested to follow three cycles (of 5 day each), for three consecutive months, of a Fasting Mimicking Diet, a plant-based, low-calorie, low-protein, low-carbohydrate, high-unsaturated fat diet. For the remaining 25 days of each month, participants should continue with their habitual eating habits. | Other | FMD Group |
Primary outcome
Activation of beige/brown adipose tissue - Volume
Time frame: Three months
Changes from baseline maximum Standardized Uptake Values (SUVmax) and mean Standardized Uptake Values (SUVmean), as assessed by PET/CT (FDG-18).
Activation of beige/brown adipose tissue - Temperature
Time frame: Three months
Changes from baseline BAT temperature, as assessed by Thermal Imaging.
Activation of beige/brown adipose tissue - Adipokines
Time frame: Three months
Changes from baseline BAT adipokines, as assessed by ELISA.
Activation of beige/brown adipose tissue - Activation Genes
Time frame: Three months
Changes from baseline BAT activation genes, as assessed by PCR.
5 secondary outcomes
Basal metabolic rates (BMR)
Time frame: Three months
Metabolic markers
Time frame: Three months
Hormones
Time frame: Three months
Inflammatory markers
Time frame: Three months
Insulin Sensitivity
Time frame: Three months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 30131768Carpentier AC, Blondin DP, Virtanen KA, Richard D, Haman F, Turcotte EE. Brown Adipose Tissue Energy Metabolism in Humans. Front Endocrinol (Lausanne). 2018 Aug 7;9:447. doi: 10.3389/fendo.2018.00447. eCollection 2018.
- Background: PubMed 28739898Leitner BP, Huang S, Brychta RJ, Duckworth CJ, Baskin AS, McGehee S, Tal I, Dieckmann W, Gupta G, Kolodny GM, Pacak K, Herscovitch P, Cypess AM, Chen KY. Mapping of human brown adipose tissue in lean and obese young men. Proc Natl Acad Sci U S A. 2017 Aug 8;114(32):8649-8654. doi: 10.1073/pnas.1705287114. Epub 2017 Jul 24.
- Background: PubMed 25994805Rachid B, van de Sande-Lee S, Rodovalho S, Folli F, Beltramini GC, Morari J, Amorim BJ, Pedro T, Ramalho AF, Bombassaro B, Tincani AJ, Chaim E, Pareja JC, Geloneze B, Ramos CD, Cendes F, Saad MJ, Velloso LA. Distinct regulation of hypothalamic and brown/beige adipose tissue activities in human obesity. Int J Obes (Lond). 2015 Oct;39(10):1515-22. doi: 10.1038/ijo.2015.94. Epub 2015 May 21.
- ProLon, a Fasting Mimicking DietLink provided by the sponsor.
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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.
Marcela R Simoes, MS Candidate principal investigator
University of Campinas
Licio A Velloso, Professor study director
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking Diet in people with Obesity, run by University of Campinas, Brazil at 1 site in Brazil.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 11 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 Brazil. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Activation of beige/brown adipose tissue - Volume (time frame: Three months). 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?
On the ClinicalTrials.gov record for NCT04385615, which also lists 3 linked publications.
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 11 May 2026.