The MIND-GUT Digital Pilot Intervention Study

NANot yet recruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

December 31, 2026

Conditions
ObesityDepressive SymptomsAnxietyStressEating HabitDysbiosis
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.

Trial Locations (1)

54128

University of Skövde, Skövde

All Listed Sponsors
collaborator

State University of New York - Downstate Medical Center

OTHER

collaborator

Albert Einstein College of Medicine

OTHER

collaborator

Göteborg University

OTHER

collaborator

Uppsala University

OTHER

collaborator

Kristianstad University

OTHER

collaborator

University of Pavia

OTHER

collaborator

The Food Scientist AB (Sweden)

UNKNOWN

lead

University of Skövde

OTHER

NCT06374407 - The MIND-GUT Digital Pilot Intervention Study | Biotech Hunter | Biotech Hunter