An Evaluation of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial
4. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert 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).
Studietype
Observasjonsmessig
Registrering (Antatt)
300
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Biofortis Research Clinical Director
- Telefonnummer: (630) 617-2000
- E-post: biofortisresearch@mxns.com
Studiesteder
-
-
Illinois
-
Addison, Illinois, Forente stater, 60101
- Rekruttering
- Biofortis Clinical Research
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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 intervensjon: observasjonskohort
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Erin Barrett, PhD, Shaklee Corporation
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. mai 2026
Primær fullføring (Antatt)
1. august 2026
Studiet fullført (Antatt)
1. august 2026
Datoer for studieregistrering
Først innsendt
23. juni 2026
Først innsendt som oppfylte QC-kriteriene
4. august 2026
Først lagt ut (Faktiske)
10. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- BIO-2607
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .