The MIND-GUT Digital Pilot Intervention Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorUniversity of Skövde

About this trial

This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.

Eligibility criteria

Qualifiers

age 30- 50;

BMI ≥ 30 kg/m2;

stable physical activity;

one person per household;

Disqualifiers

use of psychiatric medications (e.g., serotonin reuptake inhibitors);

use of weight loss medications (GLP-1 receptor agonists);

food allergies affecting adherence to the MIND diet;

diagnosis of eating disorders;

Trial design

Treatments tested in this trial

  • Dietary intervention based on the MIND diet

Treatment groups

126 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Skövde

Lead sponsor

State University of New York - Downstate Medical Center

Collaborator

Albert Einstein College of Medicine

Collaborator

Göteborg University

Collaborator

Uppsala University

Collaborator

Kristianstad University

Collaborator

University of Pavia

Collaborator

The Food Scientist AB (Sweden)

Collaborator