The MIND-GUT Digital Pilot Intervention Study

Official title

Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.

Overview

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.

Detailed description

Objective of the Pilot Study and Study Design:

This 12-week randomized pilot intervention study aims to assess 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 individuals aged 30-50.

Participant Recruitment and Randomization:

Participants aged 30-50, excluding those with specific medical conditions such as psychiatric medication use, food allergies affecting diets, eating disorders, diabetes, polycystic ovary syndrome, sensory deficits, recent antibiotic use, participation in other studies, language limitations, coeliac/inflammatory bowel disease, planned weight management within 3 months, and pregnant/lactating/post-menopausal women, will be recruited for the study. Randomization will be conducted to assign eligible participants to either an intervention or control group using a meal planning smartphone app.

Clinical Assessments:

Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections.

Study Endpoints:

The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity.

Statistical Analyses:

Statistical analyses will evaluate the study feasibility, intervention effects on body weight and mental health changes, and the potential mediating roles of these effects by the gut microbiome.

Implications and Future Plans:

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.

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.

Primary outcome measures

• Program retention [Time frame: 12 weeks]
• Adherence [Time frame: 12 weeks]
• Acceptability [Time frame: 12 weeks]
• Study effectiveness: change in eating attitudes at follow-up [Time frame: 12 weeks]
• Study effectiveness: change in stress levels at follow-up [Time frame: 12 weeks]
• Study effectiveness: change in depression symptoms at follow-up [Time frame: 12 weeks]
• Study effectiveness: change in anxiety symtoms at follow-up [Time frame: 12 weeks]
• Study effectiveness: change in body weight at follow-up [Time frame: 12 weeks]
• Study effectiveness: change in % total fat mass at follow-up [Time frame: 12 weeks]
• Study effectiveness: change in % visceral fat mass at follow-up [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• age 30- 50;
• BMI ≥ 30 kg/m2;
• stable physical activity;
• one person per household;
• commitment to full protocol.

Exclusion criteria

• 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;
• diagnosis of diabetes;
• diagnosis of polycystic ovary syndrome;
• sensory deficits (e.g., COVID-19-induced loss of taste/smell);
• antibiotic use during the latest 3 months;
• participation in another study;
• language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac/inflammatory bowel disease;
• planned weight management program within three months;
• pregnancy;
• lactation;
• menopause.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Sweden · 1 center

• University of Skövde — Skövde

Identifiers

NCT: NCT06374407 · GT-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗