Tests a MIND diet app for obesity, mood and gut health
Tests a MIND-style diet with a meal app in adults with obesity.
Plain-language title generated from the registry record
Registry title: The MIND-GUT Digital Pilot Intervention Study
Key facts
- Where
- Skövde, SwedenSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 50 years old?
Source: NCT06374407, who can take part
Where in Sweden
- University of SkövdeSkövde, SwedenNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Skövde
- Trial code
- NCT06374407
- Record updated
- 18 April 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: age 30- 50; BMI ≥ 30 kg/m2; stable physical activity; one person per household; commitment to full protocol.
Exclusion: use of weight loss medications (GLP-1 receptor agonists); 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; antibiotic use during the latest 3 months; participation in another study; planned weight management program within three months; pregnancy; lactation; menopause.