The MIND-GUT Digital Pilot Intervention Study (MINDGUT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Stress; Anxiety; Depressive Symptoms; Dysbiosis; Eating Habit
• Intervention / Treatment: Behavioral: Dietary intervention based on the MIND diet

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skövde, Sweden, 54128
    • University of Skövde
    • Contact: Gianluca Tognon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; The control group comprises participants who do not receive the specific Mind diet intervention but undergo the same procedures as the intervention group, including weighing at the beginning and end of the study, completing identical questionnaires, and providing fecal samples at recruitment and follow-up. They will also use the same meal-planning app as the intervention group.	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.
Experimental: Intervention group; The intervention group consists of participants who receive the Mind diet intervention. Like the control group, they will be weighed at the start and end of the study, answer the same questionnaires, and provide fecal samples at recruitment and follow-up. Additionally, they will use the same meal-planning app as the control group, but their dietary pattern will be based on the Mind diet.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program retention	Evaluation of participants' continued engagement in the program over time i.e., % of individuals completing the second and third 24h diet recall and % of participants returning to the second visit at the end of the intervention.	12 weeks
Adherence	Measurement of participants' compliance with the assigned diet and program through 24h recall interviews, assessed comparing reported intake frequencies of each food group with the recommended intake frequencies according to the principles of the MIND diet.	12 weeks
Acceptability	Assessment of participants' experience of the program through qualitative interviews, focusing in particular on: Perception of and experience with the intervention, intervention components (dietary plans, use of the app, etc.), factors influencing participants' engagement, perceived impact on behavior and well-being, interaction with the staff, suggestions for improvement.	12 weeks
Study effectiveness: change in eating attitudes at follow-up	Comparison of a score calculated after administration of the EAT-26 questionnaire at baseline vs. follow-up. The EAT-26 comprises three subscales, namely, Dieting, Bulimia and Food Preoccupation, and Oral Control. Higher scores correspond to a worse outcome.	12 weeks
Study effectiveness: change in stress levels at follow-up	Comparison of PSS-4 questionnaire at baseline vs. follow-up. The PSS total score is calculated by reverse-coding the positive items and summing the scores for all items. The total scores range from 0 to 56, from 0 to 40, and from 0 to 16 for the PSS-14, PSS-10, and PSS-4, respectively. A higher score indicates more perceived stress.	12 weeks
Study effectiveness: change in depression symptoms at follow-up	Comparison of PHQ-9 questionnaire at baseline vs. follow-up. The PHQ-9 is a tool to assist clinicians in identifying and diagnosing major depression. It has a maximum score of 27. Higher scores correspond to worst outcomes in terms of depression symtoms.	12 weeks
Study effectiveness: change in anxiety symtoms at follow-up	Comparison of GAD-7 questionnaire at baseline vs. follow-up. Each item is scored on a four-point Likert scale (0-3) with total scores ranging from 0 to 21 with higher scores reflecting worst outcomes in terms of anxiety severity.	12 weeks
Study effectiveness: change in body weight at follow-up	Comparison of body weight at baseline vs. follow-up	12 weeks
Study effectiveness: change in % total fat mass at follow-up	Comparison of body % total fat mass at baseline vs. follow-up	12 weeks
Study effectiveness: change in % visceral fat mass at follow-up	Comparison of body % visceral fat at baseline vs. follow-up	12 weeks
Study effectiveness: change in waist circumference at follow-up	Comparison of waist circumference at baseline vs. follow-up	12 weeks
Study effectiveness: change in hip circumference at follow-up	Comparison of hip circumference at baseline vs. follow-up	12 weeks
Study effectiveness: change in microbiome variety at follow-up	Comparison of number and types of species at baseline vs. follow-up.	12 weeks

Collaborators and Investigators

• Sponsor: University of Skövde
• Collaborators: Albert Einstein College of Medicine; Uppsala University; Göteborg University; University of Pavia; State University of New York - Downstate Medical Center; Kristianstad University; The Food Scientist AB (Sweden)

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: obesity; mental health; gut microbiome; mind gut diet
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Depression; Obesity; Dysbiosis
• Other Study ID Numbers: GT-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No