NCT06374407Not yet recruiting
The MIND-GUT Digital Pilot Intervention Study
Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.
Source: ClinicalTrials.gov · Last updated 18 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 4 Apr 2024
- Start date
- Jun 2024
- Primary completion date
- May 2026
- Lead sponsor
- University of Skövde
- Diseases
- Obesity
- NCT number
- NCT06374407
What you commit to
- Study type: Interventional
- Planned participants: 126
- From Jun 2024 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of weight loss medications (GLP-1 receptor agonists);
Other illness
- use of psychiatric medications (e.g., serotonin reuptake inhibitors);
- 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);
- language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac/inflammatory bowel disease;
Other
- antibiotic use during the latest 3 months;
- participation in another study;
- planned weight management program within three months;
- pregnancy;
- lactation;
- menopause.
Who the study is looking for
- age 30- 50;
- BMI ≥ 30 kg/m2;
- stable physical activity;
- one person per household;
- commitment to full protocol.
Age in the registry: 30 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Skövde Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.