An Evaluation of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Generally Healthy Adults Who Are Long-term Supplement Users
• Intervention / Treatment: Other: No Intervention: Observational Cohort

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Biofortis Research Clinical Director; Phone Number: (630) 617-2000; Email: biofortisresearch@mxns.com

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Recruiting
      • Biofortis Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from a database of long-term Sponsor supplement users.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: No Intervention: Observational Cohort; No intervention: observational cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between biological and chronological age (years) calculated using a validated biological age calculator	Differences will be compared to an NHANES cohort, where possible.	Baseline single assessment for this observational study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure (mm Hg)	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Heart rate (beats per minute)	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Body weight (kg)	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Body mass index (kg/m2)	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Waist-to-hip ratio	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Body fat (%)	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Fat-free body mass (kg)	Differences will be assessed in comparison to an NHANES cohort	Baseline single assessment for this observational study
Grip strength (kg)	Differences will be assessed in comparison to an NHANES cohort	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	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	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	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	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	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	Baseline single assessment for this observational study

Collaborators and Investigators

• Sponsor: Shaklee Corporation
• Collaborators: Biofortis Clinical Research, Inc.; Nlumn LLC
• Investigators: Study Director: Erin Barrett, PhD, Shaklee Corporation

Publications and helpful links

General 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.
• Block 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: August 4, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 10, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BIO-2607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No