Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention

Summary

The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.

Conditions

• Diabetes Mellitus, Type 2
• Obesity
• PreDiabetes

Interventions

BEHAVIORAL

Non-intensive intervention

After an evaluation of 7 day initial food-recall, subjects will receive counseling in order to improve their dietary habits, according to the American Diabetes Association 2019 Guidelines. The goals of this intervention are (i) achieve a caloric restriction of 500 kcal from their habitual energy intake, (ii) prioritize natural, minimally processed foods with a low glycemic index and glycemic load, (iii) eat lean protein sources, both from plant and animal origin and (iv) gradual increments of fiber intake, to achieve at least the minimum recommendations for the general population. The frequency of the follow-up appointments will be every 4 weeks, alternating between a clinical control and nutritional one. Therefore, the planned nutritional follow-up frequency will be every 2 months. In these appointments, the objective will be to achieve the mentioned energy intake reduction of 500 kcal, aiming to the nutritional goals previously mentioned, with the aid of the food-recalls.

BEHAVIORAL

Intensive intervention

People will have virtual education with food and nutrition coaching workshops, as well as weekly meetings in small groups as a support and follow-up groups. The frequency of the face-to-face follow-up appointments will be every 3 weeks. The nutritional intervention will emphasize the consumption of mainly minimally processed food from plant origin. A vitamin b12 supplement per week will be provided. This intervention group will have 2 stages. First stage will have a duration of 3 months setting the nutritional bases going to a plant-based diet with basic considerations regarding fiber intake reducing meat consumption, and incorporating protein from vegetable sources, among other considerations. Second stage will progress to higher levels of fiber and others nutritional requeriments in order to intensify the nutritional plant-based intervention.

Sponsors & Collaborators

• Facultad de Ingeniería - Universidad Austral

  collaborator UNKNOWN

• Instituto de Inmunología, Genética y Metabolismo (INIGEM, CONICET-UBA)

  collaborator UNKNOWN

• Illumina, Inc.

  collaborator INDUSTRY

• Zymo Research

  collaborator UNKNOWN

• Instituto de Investigación y Desarrollo en Bioingeniería y Bioinformática (IBB, CONICET-UNER)

  collaborator UNKNOWN

• National Council of Scientific and Technical Research, Argentina

  lead OTHER_GOV

Principal Investigators

• Juan Bustamante, PhD · CONICET Researcher

• Gustavo Frechtel, PhD · CONICET Researcher

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-05-30

Primary Completion

2025-07-31

Completion

2025-07-31

Countries

• Argentina