Fasting Mimicking Diet and Beige/Brown Adipose Tissue in Humans

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

Interventions

OTHER

Fasting Mimicking Diet

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.

Sponsors & Collaborators

• University of Campinas, Brazil

  lead OTHER

Principal Investigators

• Marcela R Simoes, MS Candidate · University of Campinas

• Licio A Velloso, Professor · University of Campinas

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-28

Primary Completion

2021-12-31

Completion

2022-07-31

Countries

• Brazil

Study Locations