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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06458296
• Other study ID #: SW013
• Status: Completed
• Phase: N/A
• Start date: February 2, 2024
• Est. completion date: June 3, 2024

Study information

• Verified date: June 2024
• Source: S.LAB (SOLOWAYS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 3, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• Control Group
Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
• AI-Guided Group
Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage change in body weigh		180 days
Secondary	Change in BMI		180 days
Secondary	Percent change in high-sensitivity C-reactive		180 days
Secondary	Percent change in fasting glucose		180 days
Secondary	Percent change in insulin		180 days
Secondary	Percent change in total cholesterol		180 days
Secondary	Percent change in Low density lipoproteids		180 days
Secondary	Percent change in high density lipoprodeids		180 days
Secondary	Percent change in triglycerides		180 days
Secondary	Appetite ratings using visual analogue scale change	The scale has minimum of 0 - no appetite and 10 as a good appetite	180 days