An Observational, Cross-Sectional Study Evaluating the Impact of Long-Term Supplement Use on Biological Age and Metabolic Health Markers - The BioAge Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Difference between biological and chronological age (years) calculated using a validated biological age calculator
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Difference between biological and chronological age (years) calculated using a validated biological age calculator
时间窗: Baseline single assessment for this observational study
Differences will be compared to an NHANES cohort, where possible.
次要结局
- Blood pressure (mm Hg)(Baseline single assessment for this observational study)
- Heart rate (beats per minute)(Baseline single assessment for this observational study)
- Body weight (kg)(Baseline single assessment for this observational study)
- Body mass index (kg/m2)(Baseline single assessment for this observational study)
- Waist-to-hip ratio(Baseline single assessment for this observational study)
- Body fat (%)(Baseline single assessment for this observational study)
- Fat-free body mass (kg)(Baseline single assessment for this observational study)
- Grip strength (kg)(Single assessment for this observational study)
- Lower body strength assessed using the chair stand test (total number of stands)(Baseline single assessment for this observational study)
- Flexibility assessed using the sit and reach test (distance in inches reached)(Baseline single assessment for this observational study)
- Balance assessed using the one-legged stance test (hold time in seconds)(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)(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)(Baseline single assessment for this observational study)
- Social connection as assessed by the NIH Social Connection and Isolation Panel questionnaire (total score)(Baseline single assessment for this observational study)
