Clinical trial NCT06374407: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Depressive Symptoms
Anxiety
Stress
Eating Habit
Dysbiosis
Keywords: mental health
obesity
mind gut diet
gut microbiome
Lead sponsor: University of Skövde
Sponsor class: OTHER
Collaborators: name: State University of New York - Downstate Medical Center
name: Albert Einstein College of Medicine
name: Göteborg University
name: Uppsala University
name: Kristianstad University
name: University of Pavia
name: The Food Scientist AB (Sweden)
First posted: 2024-04-18
Enrollment: 126
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We plan to randomly assign participants to either the intervention or control group.
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Program retention
timeFrame: 12 weeks
measure: Adherence
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Study effectiveness: change in eating attitudes at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in stress levels at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in depression symptoms at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in anxiety symtoms at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in body weight at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in % total fat mass at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in % visceral fat mass at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in waist circumference at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in hip circumference at follow-up
timeFrame: 12 weeks
measure: Study effectiveness: change in microbiome variety at follow-up
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: University of Skövde
Study officials:
References: