Metabolic and Functional Consequences of Aging in Health and Disease
ConditionAging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorTexas A&M University
About this trial
Considerable heterogeneity in the aging population has been observed. The exceptional longevity of individuals reaching 100 years old, so-called centenarians may be an example of life-long healthy aging, or added years may be spent in poor health with decreased physical and cognitive functioning. Current knowledge of the aging experience and the trajectories of physical and cognitive decline across various age groups are not well-understood, yet crucial to prevent spending added years in disease. Hence, the study objective is to develop the metabolic profile associated with aging-related disorders measured as the incidence of impaired functional capacity, cognitive function, and/or well-being.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Stable body-weight (± 5%) for the past 3 months
Subject is judged to be in satisfactory health based on medical history, physical examination, and laboratory screening evaluations.
Ability to walk, sit down and stand up independently or with walking mobility aids
Ability to lie in a supine or elevated position for up to 3 hours
Disqualifiers
Insulin dependent diabetes mellitus
Established diagnosis of malignancy
History of untreated metabolic diseases including hepatic or renal disorder
Presence of acute illness or metabolically unstable chronic illness
Trial population
We will screen 400 subjects (to complete n=320). This number includes screen failures and drop-outs. We expect some dropout between screening and enrollment. Subjects who drop out prior to the successful completion of the study will be replaced. Data will be used up to the point of withdrawal. Age range: 50 years or older, inclusive; Ethnicity: all races and ethnicities.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Stable tracer infusion in a postabsorptive state
Other interventionMultiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Controls1 intervention
Trial outcomes
Primary outcomes
1
Age-related changes in whole-body protein and amino acid metabolism
Whole-body production rate measured after stable tracer administration
Time frame
2 hoursSecondary outcomes
1
Age-related changes in whole-body glucose metabolism
Whole-body production rate measured after stable tracer administration
Time frame
2 hours2
Age-related changes in whole-body fat metabolism
Whole-body production rate measured after stable tracer administration
Time frame
2 hours3
Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)
Self-reported depression measured by a validated questionnaire related to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms). A higher score indicates a worse outcome (greater self-reported depression symptoms).
Time frame
baseline visit4
Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
Anxiety measured by a validated questionnaire related to anxiety-related symptoms. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) related to anxiety. A higher score indicates a worse outcome (greater self-reported anxiety symptoms).
Time frame
baseline visitOther outcomes
1
Age-related changes in hand dexterity
Hand dexterity assessed by the Nine-Hole Peg Test (9-HPT), a standardized, quantitative assessment in which the subject is asked to take pegs from a container, one by one, and place them into the holes on the board. Time upon completion will be recorded using both left and right hand, separately.
Time frame
baseline visitSponsors and contacts
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Source ClinicalTrials.gov