Clinical trial NCT06458296: Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients
Official title: Evaluating the Efficacy of AI-Guided vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Dietary Supplements
AI-guided prescriptions
Genetic profiling
Metabolic profiling
Lead sponsor: S.LAB (SOLOWAYS)
Sponsor class: OTHER
Collaborators: name: Center of New Medical Technologies
First posted: 2024-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: percentage change in body weigh
timeFrame: 180 days
Secondary outcomes:
measure: Change in BMI
timeFrame: 180 days
measure: Percent change in high-sensitivity C-reactive
timeFrame: 180 days
measure: Percent change in fasting glucose
timeFrame: 180 days
measure: Percent change in insulin
timeFrame: 180 days
measure: Percent change in total cholesterol
timeFrame: 180 days
measure: Percent change in Low density lipoproteids
timeFrame: 180 days
measure: Percent change in high density lipoprodeids
timeFrame: 180 days
measure: Percent change in triglycerides
timeFrame: 180 days
measure: Appetite ratings using visual analogue scale change
timeFrame: 180 days
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Center of New Medical Technologies
state: Novosibisk Region
Study officials:
References: