Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Other: Control Group; Other: AI-Guided Group

• Registration Number: NCT06458296
• Lead Sponsor: S.LAB (SOLOWAYS)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-02
• Primary Completion: 2024-05-15
• Status Verified: 2024-06
• Study Completion: 2024-06-03
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-09
• Last Update Submitted: 2024-06-09
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control Group	-
AI-Guided Group	AI-Guided Group	-

Primary Outcome Measures

Name	Time	Method
percentage change in body weigh	180 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation