The MIND-GUT Digital Pilot Intervention Study

Summary

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.

Conditions

• Obesity
• Depressive Symptoms
• Anxiety
• Stress
• Eating Habit
• Dysbiosis

Interventions

BEHAVIORAL

Dietary intervention based on the MIND diet

A 12-week pilot randomized controlled trial (RCT) involving N=126 obese participants (1:1 gender ratio) to assess protocol feasibility, including recruitment, retention, compliance, physical examinations, and gut sample collection. Sample size, calculated by a statistician, expects a 5% body weight change at follow-up (std. dev. 10%). We chose a 12-week duration for this pilot study to allow sufficient time to observe significant changes in both body weight and mental health.

Sponsors & Collaborators

• State University of New York - Downstate Medical Center

  collaborator OTHER

• Albert Einstein College of Medicine

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• Kristianstad University

  collaborator OTHER

• University of Pavia

  collaborator OTHER

• The Food Scientist AB (Sweden)

  collaborator UNKNOWN

• University of Skövde

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-06-30

Primary Completion

2026-05-31

Completion

2026-12-31

Countries

• Sweden

Study Locations