Generally Healthy Adults Who Are Long-term Supplement Users
Conditions
Brief 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.
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).
Interventions
OTHERNo Intervention: Observational Cohort
No intervention: observational cohort
Sponsors
Shaklee Corporation
Biofortis Clinical Research, Inc.
Nlumn LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference between biological and chronological age (years) calculated using a validated biological age calculator | Baseline single assessment for this observational study | Differences will be compared to an NHANES cohort, where possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure (mm Hg) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Heart rate (beats per minute) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Body weight (kg) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Body mass index (kg/m2) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Waist-to-hip ratio | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Body fat (%) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Fat-free body mass (kg) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Grip strength (kg) | Single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Lower body strength assessed using the chair stand test (total number of stands) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Flexibility assessed using the sit and reach test (distance in inches reached) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Balance assessed using the one-legged stance test (hold time in seconds) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Quality of life as assessed by the CDC HRQOL-4 questionnaire (overall health rating and number of days) | Single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Cognition as assessed by the cognition scale of the Fatigue and Altered Cognition Scale questionnaire (cognition scale total score) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
| Social connection as assessed by the NIH Social Connection and Isolation Panel questionnaire (total score) | Baseline single assessment for this observational study | Differences will be assessed in comparison to an NHANES cohort |
Countries
United States
Contacts
CONTACTBiofortis Research Clinical Director
STUDY_DIRECTORErin Barrett, PhD
Shaklee Corporation
Outcome results
None listed