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

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Control Group; Other: AI-Guided Group

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibisk Region
    • Novosibirsk, Novosibisk Region, Russian Federation, 630090
      • Center of New Medical Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group	Other: Control Group; Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
Experimental: AI-Guided Group	Other: AI-Guided Group; Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage change in body weigh	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BMI		180 days
Percent change in high-sensitivity C-reactive		180 days
Percent change in fasting glucose		180 days
Percent change in insulin		180 days
Percent change in total cholesterol		180 days
Percent change in Low density lipoproteids		180 days
Percent change in high density lipoprodeids		180 days
Percent change in triglycerides		180 days
Appetite ratings using visual analogue scale change	The scale has minimum of 0 - no appetite and 10 as a good appetite	180 days

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center of New Medical Technologies

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): May 15, 2024
• Study Completion (Actual): June 3, 2024

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 9, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 9, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Dietary Supplements; Genetic profiling; AI-guided prescriptions; Metabolic profiling
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: SW013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No