Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 126
Trial details
Age: 30-50Biological sex: AllType: InterventionalSponsor: University of SkövdeUpdated: Apr 18, 2024Locations: 1
Eligibility criteria

age 30- 50; [+4]

use of psychiatric medications (e.g., serotonin reuptake inhibitors); [+13]