Fasting Mimicking Diet and Beige/Brown Adipose Tissue in Humans

NCT04385615 | Unknown DMC

• 1 other identifier: CAAE: 20037719.0.0000.5404
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity

Keywords

Obesity; Fasting Mimicking Diet (FMD); Brown Adipose Tissue (BAT)

Outcome Measures

Primary Outcomes (4)

• 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).

  Three months

• Activation of beige/brown adipose tissue - Temperature

  Changes from baseline BAT temperature, as assessed by Thermal Imaging.

  Three months

• Activation of beige/brown adipose tissue - Adipokines

  Changes from baseline BAT adipokines, as assessed by ELISA.

  Three months

• Activation of beige/brown adipose tissue - Activation Genes

  Changes from baseline BAT activation genes, as assessed by PCR.

  Three months

Secondary Outcomes (5)

• Basal metabolic rates (BMR)

  Three months

• Metabolic markers

  Three months

• Hormones

  Three months

• Inflammatory markers

  Three months

• Insulin Sensitivity

  Three months

Study Arms (2)

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.

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.

Interventions

Fasting Mimicking Diet OTHER

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.

FMD Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) ≥ 25 and \< 30kg/m2.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

School of Medical Sciences - University of Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (3)

• 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.

  PMID: 30131768 BACKGROUND

• Leitner 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.

  PMID: 28739898 BACKGROUND

• Rachid 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.

  PMID: 25994805 BACKGROUND

Related Links

• ProLon, a Fasting Mimicking Diet

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Marcela R Simoes, MS Candidate

  University of Campinas

  PRINCIPAL INVESTIGATOR

• Licio A Velloso, Professor

  University of Campinas

  STUDY DIRECTOR

Central Study Contacts

Marcela R Simoes, MS Candidate

CONTACT

+5519994757517; marcela.rsimoes@gmail.com

Licio A Velloso, Professor

CONTACT

+551935217191; lavelloso.unicamp@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One group will receive the FMD diet. The other group will be the control.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 13, 2020
• Study Start: May 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

BR (1)