NCT06458296Completed
Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients
Evaluating the Efficacy of AI-Guided vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients: A Randomized Controlled Pilot Trial
Source: ClinicalTrials.gov · Last updated 13 Jun 2024
Brief summary (registry, in English)
Obesity, a chronic disease characterized by excessive fat accumulation, significantly impacts health. Genetic factors influence the development of obesity by affecting behavioral, dietary habits, and metabolic processes. This study investigated whether dietary supplements (DS), personalized through genetic and metabolic profiling, could enhance weight loss when combined with physical activity and dietary changes. The objective was to compare the efficacy of standard physician-guided DS prescriptions with AI-guided DS prescriptions in promoting weight loss in obese patients. The hypothesis was that AI-guided DS prescriptions, utilizing detailed genetic and metabolic data, would be more effective in promoting weight loss than standard physician-guided DS prescriptions. This was a 6-month randomized, controlled pilot clinical trial with an additional 6-month follow-up. Participants were healthy individuals aged 40-60 years with a BMI of 25 or greater. Participants were excluded if they had significant medical conditions or recent changes in medication or supplements. They were randomly assigned to either the control group (physician-guided DS prescriptions) or the AI-guided group (AI-determined DS prescriptions). The AI system developed by Triangel Scientific analyzed genetic, metabolic, and biochemical data to personalize treatment. Baseline measurements included comprehensive metabolic panels, genetic testing, metabolomic profiling, and detailed patient history
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 4 Jun 2024
- Start date
- 2 Feb 2024
- Primary completion date
- 15 May 2024
- Lead sponsor
- S.LAB (SOLOWAYS)
- Diseases
- Obesity
- NCT number
- NCT06458296
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 2 Feb 2024 to the primary completion date, 15 May 2024
- 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
- Individuals who have taken any prescribed medications or dietary supplements in the two weeks prior to the study.
- Those with a clinically significant history of major digestive, liver, kidney, cardiovascular, hematological diseases, diabetes, gastrointestinal disorders, or any other serious acute or chronic medical conditions.
Who the study is looking for
- Healthy participants aged between 40 and 60 years.
- BMI of 25 or greater and no more than a 3% change in body mass within the last three months.
Age in the registry: 40 years to 60 years · Sex: All · Does not accept 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 |
|---|---|---|---|
| Center of New Medical Technologies Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.