ObesityNCT06458296
Evaluating the Efficacy of AI-Guided (GenAIS TM) vs. Standard Physician-Guided Dietary Supplement Prescriptions for Weight Loss in Obese Patients
A study testing AI-Guided Group in people with Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- AI-Guided Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 2 Feb 2024to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
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
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
- Being tested
- Control Group, AI-Guided Group
- Keywords
- Dietary Supplements, AI-guided prescriptions, Genetic profiling, Metabolic profiling
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Participants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.
AI-Guided GroupOther
Participants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Control Group |
| AI-Guided Group | Experimental | Not described Receives: Other: AI-Guided Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage change in body weigh
Measured: 180 days
Secondary outcomes (9)
Change in BMI
Measured: 180 days
Percent change in high-sensitivity C-reactive
Measured: 180 days
Percent change in fasting glucose
Measured: 180 days
Percent change in insulin
Measured: 180 days
Percent change in total cholesterol
Measured: 180 days
Percent change in Low density lipoproteids
Measured: 180 days
Percent change in high density lipoprodeids
Measured: 180 days
Percent change in triglycerides
Measured: 180 days
Appetite ratings using visual analogue scale change
The scale has minimum of 0 - no appetite and 10 as a good appetite
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start2 Feb 2024
- Primary completion15 May 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458296
- Sponsor's protocol ID
- SW013
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40562096
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06458296
- Acronym / sponsor ID
- SW013
- Conditions
- Obesity
- Keywords
- Dietary Supplements, AI-guided prescriptions, Genetic profiling, Metabolic profiling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control Group |
| AI-Guided Group | Experimental | Other: AI-Guided Group |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who have taken any prescribed medications or dietary supplements in the two weeks prior to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control GroupParticipants receive DS prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles. | Other | Control Group |
| AI-Guided GroupParticipants receive DS prescriptions determined by an AI system, which considers genetic data, metabolic profiles, biochemical markers, and patient history. | Other | AI-Guided Group |
Primary outcome
percentage change in body weigh
Time frame: 180 days
9 secondary outcomes
Change in BMI
Time frame: 180 days
Percent change in high-sensitivity C-reactive
Time frame: 180 days
Percent change in fasting glucose
Time frame: 180 days
Percent change in insulin
Time frame: 180 days
Percent change in total cholesterol
Time frame: 180 days
Percent change in Low density lipoproteids
Time frame: 180 days
Percent change in high density lipoprodeids
Time frame: 180 days
Percent change in triglycerides
Time frame: 180 days
Appetite ratings using visual analogue scale change
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Derived from this study: PubMed 40562096Pokushalov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Group in people with Obesity, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage change in body weigh (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06458296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.