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

NCT06458296 | Completed

• 1 other identifier: SW013
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• percentage change in body weigh

  180 days

Secondary Outcomes (9)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Other: Control Group

AI-Guided Group

EXPERIMENTAL

Other: AI-Guided Group

Interventions

Control Group OTHER

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

Control Group

AI-Guided Group OTHER

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

AI-Guided Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

Related Publications (1)

• Pokushalov E, Garcia C, Ponomarenko A, Samoilova I, Smith J, Johnson M, Pak I, Shrainer E, Kudlay D, Romanova A, Miller R. Optimizing weight loss with artificial intelligence: A randomized controlled trial of dietary-supplement prescriptions in adults with overweight and obesity. Clin Nutr ESPEN. 2025 Oct;69:75-86. doi: 10.1016/j.clnesp.2025.06.035. Epub 2025 Jun 23.

  PMID: 40562096 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 13, 2024
• Study Start: February 2, 2024
• Primary Completion: May 15, 2024
• Study Completion: June 3, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

RU (1)