Generally Healthy Adults Who Are Long-term Supplement UsersNCT07755943
An Evaluation of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial
An observational study of Generally Healthy Adults Who Are Long-term Supplement Users, run by Shaklee Corporation at 1 site in United States.
Trial summary
This study will evaluate whether dietary supplement use (> 1 year) is associated with differences in biological age relative to chronological age, as well as differences in metabolic health and functional fitness tests. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Generally Healthy Adults Who Are Long-term Supplement Users
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from a database of long-term Sponsor supplement users.
Who may be able to join
- Adults aged 40 years or older.
- Verified long-term Sponsor supplement use (>1 year).
- Willing and able to provide informed consent and comply with study procedures.
- Able to fast overnight (>8 hours) prior to the study visit.
- Willing and able to travel to the test site.
- Ambulatory and currently free of injury or other physical impairment that hinders mobility.
- Willing to use a personal smart phone or computer with internet access and active email address.
- Willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information.
Who cannot join
- Current or recent (within 6 months) diagnosis of cancer except for non-melanoma skin cancer.
- Participant is pregnant or lactating.
- Participant has a pacemaker or other implanted electronic device.
- Any condition the study staff believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: An Observational, Cross-Sectional Study Evaluating the Impact of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial
This study will evaluate whether dietary supplement use (> 1 year) is associated with differences in biological age relative to chronological age, as well as differences in metabolic health and functional fitness tests.
Read the detailed description
Using a cross-sectional study design, information will be obtained by biomarker analysis, questionnaires, physical examination, and physical function from a convenience sample of long-term users of dietary supplements. Comparison data for non-users and single multivitamin/mineral and multiple supplement users will be obtained from the National Health and Nutrition Examination Survey (NHANES).
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention: observational cohort
| Study group | Role | What they receive |
|---|---|---|
| Generally healthy adults, 40 years of age and older, who are long-term (>1 year) supplement users | Participants will be long-term users (>1 year) of the Sponsors supplement products Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between biological and chronological age (years) calculated using a validated biological age calculator
Differences will be compared to an NHANES cohort, where possible.
Measured: Baseline single assessment for this observational study
Secondary outcomes (14)
Blood pressure (mm Hg)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Heart rate (beats per minute)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Body weight (kg)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Body mass index (kg/m2)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Waist-to-hip ratio
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Body fat (%)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Fat-free body mass (kg)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Grip strength (kg)
Differences will be assessed in comparison to an NHANES cohort
Measured: Single assessment for this observational study
Lower body strength assessed using the chair stand test (total number of stands)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Flexibility assessed using the sit and reach test (distance in inches reached)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Balance assessed using the one-legged stance test (hold time in seconds)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Quality of life as assessed by the CDC HRQOL-4 questionnaire (overall health rating and number of days)
Differences will be assessed in comparison to an NHANES cohort
Measured: Single assessment for this observational study
Cognition as assessed by the cognition scale of the Fatigue and Altered Cognition Scale questionnaire (cognition scale total score)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Social connection as assessed by the NIH Social Connection and Isolation Panel questionnaire (total score)
Differences will be assessed in comparison to an NHANES cohort
Measured: Baseline single assessment for this observational study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start12 May 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generally Healthy Adults Who Are Long-term Supplement UsersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaklee Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Nlumn LLC
- Responsible party
- Sponsor
- Investigators
- Erin Barrett, PhD, Study director, Shaklee Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755943
- Sponsor's protocol ID
- BIO-2607
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jacques PF, Rogers G. A beneficial cardiometabolic health profile associated with dietary supplement use: A cross-sectional study. Int J Vitam Nutr Res. 2023 Feb;93(1):18-28. doi: 10.1024/0300-9831/a000701. Epub 2021 Mar 1.
PubMed 33646010Block G, Jensen CD, Norkus EP, Dalvi TB, Wong LG, McManus JF, Hudes ML. Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study. Nutr J. 2007 Oct 24;6:30. doi: 10.1186/1475-2891-6-30.
PubMed 17958896
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Cross-Sectional Study Evaluating the Impact of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial
- ClinicalTrials.gov ID
- NCT07755943
- Acronym / sponsor ID
- BIO-2607
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shaklee CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc., Nlumn LLC
- Study start
- 12 May 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Aug 2026 (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.
This study will evaluate whether dietary supplement use (> 1 year) is associated with differences in biological age relative to chronological age, as well as differences in metabolic health and functional fitness tests.
Detailed description
Using a cross-sectional study design, information will be obtained by biomarker analysis, questionnaires, physical examination, and physical function from a convenience sample of long-term users of dietary supplements. Comparison data for non-users and single multivitamin/mineral and multiple supplement users will be obtained from the National Health and Nutrition Examination Survey (NHANES).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Generally healthy adults, 40 years of age and older, who are long-term (>1 year) supplement users | – | Other: No Intervention: Observational CohortParticipants will be long-term users (>1 year) of the Sponsors supplement products |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from a database of long-term Sponsor supplement users.
Key inclusion criteria (8 listed)
- Adults aged 40 years or older.
- Verified long-term Sponsor supplement use (>1 year).
- Willing and able to provide informed consent and comply with study procedures.
- Able to fast overnight (>8 hours) prior to the study visit.
- Willing and able to travel to the test site.
Key exclusion criteria (4 listed)
- Current or recent (within 6 months) diagnosis of cancer except for non-melanoma skin cancer.
- Participant is pregnant or lactating.
- Participant has a pacemaker or other implanted electronic device.
- Any condition the study staff believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention: observational cohort | Other | Generally healthy adults, 40 years of age and older, who are long-term (>1 year) supplement users |
Primary outcome
Difference between biological and chronological age (years) calculated using a validated biological age calculator
Time frame: Baseline single assessment for this observational study
Differences will be compared to an NHANES cohort, where possible.
14 secondary outcomes
Blood pressure (mm Hg)
Time frame: Baseline single assessment for this observational study
Heart rate (beats per minute)
Time frame: Baseline single assessment for this observational study
Body weight (kg)
Time frame: Baseline single assessment for this observational study
Body mass index (kg/m2)
Time frame: Baseline single assessment for this observational study
Waist-to-hip ratio
Time frame: Baseline single assessment for this observational study
Body fat (%)
Time frame: Baseline single assessment for this observational study
Fat-free body mass (kg)
Time frame: Baseline single assessment for this observational study
Grip strength (kg)
Time frame: Single assessment for this observational study
Lower body strength assessed using the chair stand test (total number of stands)
Time frame: Baseline single assessment for this observational study
Flexibility assessed using the sit and reach test (distance in inches reached)
Time frame: Baseline single assessment for this observational study
Balance assessed using the one-legged stance test (hold time in seconds)
Time frame: Baseline single assessment for this observational study
Quality of life as assessed by the CDC HRQOL-4 questionnaire (overall health rating and number of days)
Time frame: Single assessment for this observational study
Cognition as assessed by the cognition scale of the Fatigue and Altered Cognition Scale questionnaire (cognition scale total score)
Time frame: Baseline single assessment for this observational study
Social connection as assessed by the NIH Social Connection and Isolation Panel questionnaire (total score)
Time frame: Baseline single assessment for this observational study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 33646010Jacques PF, Rogers G. A beneficial cardiometabolic health profile associated with dietary supplement use: A cross-sectional study. Int J Vitam Nutr Res. 2023 Feb;93(1):18-28. doi: 10.1024/0300-9831/a000701. Epub 2021 Mar 1.
- Results publication: PubMed 17958896Block G, Jensen CD, Norkus EP, Dalvi TB, Wong LG, McManus JF, Hudes ML. Usage patterns, health, and nutritional status of long-term multiple dietary supplement users: a cross-sectional study. Nutr J. 2007 Oct 24;6:30. doi: 10.1186/1475-2891-6-30.
- Individual participant dataSharing planned: No
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.
Erin Barrett, PhD study director
Shaklee Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generally Healthy Adults Who Are Long-term Supplement Users, run by Shaklee Corporation at 1 site in United States.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biofortis Research Clinical Director ((630) 617-2000, biofortisresearch@mxns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between biological and chronological age (years) calculated using a validated biological age calculator (time frame: Baseline single assessment for this observational study). 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 NCT07755943, which also lists 2 linked publications.
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 10 Aug 2026.