Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06458296
Enrollment
80
Registered
2024-06-13
Start date
2024-02-02
Completion date
2024-06-03
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Dietary Supplements, AI-guided prescriptions, Genetic profiling, Metabolic profiling

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

Interventions

OTHERControl Group

Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Sponsors

Center of New Medical Technologies
CollaboratorOTHER
S.LAB (SOLOWAYS)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
percentage change in body weigh180 days

Secondary

MeasureTime frameDescription
Percent change in high-sensitivity C-reactive180 days
Percent change in fasting glucose180 days
Percent change in insulin180 days
Percent change in total cholesterol180 days
Change in BMI180 days
Percent change in high density lipoprodeids180 days
Percent change in triglycerides180 days
Appetite ratings using visual analogue scale change180 daysThe scale has minimum of 0 - no appetite and 10 as a good appetite
Percent change in Low density lipoproteids180 days

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026