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OpenTrials
Completed

NCT Number: NCT06458296

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

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

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Other

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

AI-Guided Group

Other

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

Primary outcomes

  1. percentage change in body weigh

    Time frame: 180 days

Secondary outcomes

  1. Change in BMI

    Time frame: 180 days

  2. Percent change in high-sensitivity C-reactive

    Time frame: 180 days

  3. Percent change in fasting glucose

    Time frame: 180 days

  4. Percent change in insulin

    Time frame: 180 days

  5. Percent change in total cholesterol

    Time frame: 180 days

  6. Percent change in Low density lipoproteids

    Time frame: 180 days

  7. Percent change in high density lipoprodeids

    Time frame: 180 days

  8. Percent change in triglycerides

    Time frame: 180 days

  9. Appetite ratings using visual analogue scale change

    Time frame: 180 days

    The scale has minimum of 0 - no appetite and 10 as a good appetite

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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