The MIND-GUT Digital Pilot Intervention Study (MINDGUT)

University of Skövde

Status: Not yet enrolling

Conditions: Dysbiosis; Depressive Symptoms; Eating Habit; Obesity; Anxiety; Stress

Treatments: Behavioral: Dietary intervention based on the MIND diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06374407

GT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

126 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Dietary intervention based on the MIND diet

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Dietary intervention based on the MIND diet