An Evaluation of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial
4. august 2026 opdateret af: Shaklee Corporation
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.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Anslået)
300
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Biofortis Research Clinical Director
- Telefonnummer: (630) 617-2000
- E-mail: biofortisresearch@mxns.com
Studiesteder
-
-
Illinois
-
Addison, Illinois, Forenede Stater, 60101
- Rekruttering
- Biofortis Clinical Research
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Participants will be recruited from a database of long-term Sponsor supplement users.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
Ingen intervention: observationskohorte
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference between biological and chronological age (years) calculated using a validated biological age calculator
Tidsramme: Baseline single assessment for this observational study
|
Differences will be compared to an NHANES cohort, where possible.
|
Baseline single assessment for this observational study
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Blood pressure (mm Hg)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Heart rate (beats per minute)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Body weight (kg)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Body mass index (kg/m2)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Waist-to-hip ratio
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Body fat (%)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Fat-free body mass (kg)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
|
Grip strength (kg)
Tidsramme: Single assessment for this observational study
|
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)
Tidsramme: Baseline single assessment for this observational study
|
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)
Tidsramme: Baseline single assessment for this observational study
|
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)
Tidsramme: Baseline single assessment for this observational study
|
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)
Tidsramme: Single assessment for this observational study
|
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)
Tidsramme: Baseline single assessment for this observational study
|
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)
Tidsramme: Baseline single assessment for this observational study
|
Differences will be assessed in comparison to an NHANES cohort
|
Baseline single assessment for this observational study
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Erin Barrett, PhD, Shaklee Corporation
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. maj 2026
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
1. august 2026
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
4. august 2026
Først opslået (Faktiske)
10. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- BIO-2607
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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