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

NARecruitingINTERVENTIONAL
Enrollment

480

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

August 31, 2025

Study Completion Date

December 31, 2025

Conditions
Diabetes Mellitus, Type 2ObesityPreDiabetes
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."

Trial Locations (1)

C1120AAR

RECRUITING

"Hospital de Clínicas José de San Martín", Capital Federal

Sponsors
All Listed Sponsors
collaborator

Facultad de Ingeniería - Universidad Austral

UNKNOWN

collaborator

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

UNKNOWN

collaborator

Illumina, Inc.

INDUSTRY

collaborator

Zymo Research

UNKNOWN

collaborator

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

UNKNOWN

lead

National Council of Scientific and Technical Research, Argentina

OTHER_GOV