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Metabolic and Functional Consequences of Aging in Health and Disease

Metabolic and Functional Consequences of Aging in Health and Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05240885
Enrollment
100
Registered
2022-02-15
Start date
2022-03-04
Completion date
2026-09-30
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

stable isotopes, disease, metabolism

Brief summary

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.

Detailed description

Our lab developed a pulse method combining multiple stable tracers to study multiple metabolic pathways in the same individual simultaneously. By measuring whole-body metabolism in a large group of older adults, we may be able to unravel age-related deterioration in protein turnover (synthesis and breakdown) that contributes to impaired functional capacity. Metabolic profiles could explain differences in pathways in the aging process with a special interest in the metabolism of amino acids as they have been associated with aging-related disorders. Studies on the effect of aging on metabolism might serve as potential therapeutic targets.

Interventions

OTHERStable tracer infusion in a postabsorptive state

Multiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids

Sponsors

Texas A&M University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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 * Willingness and ability to comply with the protocol

Exclusion criteria

* 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 * Presence of fever within the last 3 days * Use of short course of oral corticosteroids within 4 weeks preceding study day * Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * (Possible) pregnancy * Already enrolled in another clinical trial and that clinical trial interferes with participating in this study

Design outcomes

Primary

MeasureTime frameDescription
Age-related changes in whole-body protein and amino acid metabolism2 hoursWhole-body production rate measured after stable tracer administration

Secondary

MeasureTime frameDescription
Age-related changes in whole-body glucose metabolism2 hoursWhole-body production rate measured after stable tracer administration
Age-related changes in whole-body fat metabolism2 hoursWhole-body production rate measured after stable tracer administration
Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)baseline visitSelf-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).
Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)baseline visitAnxiety 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).
Age-related changes in mood as measured by the Profile of Mood State (POMS)baseline visitA psychological distress scale to measure the mood disturbance in 6 domains - fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment in the past week. Each item on the questionnaire is awarded a score from 0 (not at all) to 4 (extremely), except Relaxed and Efficient scored 4 (not at all) and 0 (extremely), based on the intensity of the assessed feeling in the past week.
Age-related changes in health statusbaseline visitHealth status assessed by Health-Related Quality of Life Scale (HR-QoL)
Age-related changes in physical activitybaseline visitPhysical activity assessed by Physical Activity Scale for the Elderly (PASE)
Age-related changes in sleep qualitybaseline visitSleep quality assessed by Pittsburgh Sleep Quality Index
Age-related changes in nutritional statusbaseline visitNutritional status assessed by Mini-Nutritional Assessment
Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)baseline visitMoCa assesses several cognitive domains and is used for the screening of mild cognitive impairment. Total scores range from 0-30 with lower scores indicating decreased functioning.
Age-related changes in exercise capacitybaseline visitFunctional exercise capacity assessed by 6-minute walk test
Age-related changes in physical weakness (frailty)baseline visitPhysical weakness assessed by Short Physical Performance Battery
Age-related changes in skeletal muscle strength of the upper extremitybaseline visitSkeletal muscle strength measured by handgrip test
Age-related changes in skeletal muscle strength of the lower extremitybaseline visitSkeletal muscle strength measured by one-leg test
Age-related changes in respiratory muscle strengthbaseline visitRespiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM)
Age-related changes in balancebaseline visitSkeletal muscle strength measured by Berg Balance Scale and balance platform
Age-related changes in gut microbiotabaseline visitThe amount and types of microbiota assessed in collected stool sample
Age-related changes in gut functionbaseline visitGut function assessed by Gastrointestinal Symptom Rating Scale, a 15-item instrument designed to assess the symptoms associated with common gastrointestinal disorders. A higher score indicates worse outcomes (more discomfort).
Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)baseline visitIn Part A, the examinee is instructed to connect a set of 25 circles with numbers as quickly as possible while maintaining accuracy. In Part B, the examinee is instructed to connect a set of 25 circles, alternating between numbers and letters, as quickly as possible while maintaining accuracy. Measures attentional resources and is a measure of the frontal lobe executive functions of visual search, set-switching and mental flexibility. The total time in seconds was reported for each measure.

Other

MeasureTime frameDescription
Age-related changes in hand dexteritybaseline visitHand 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.

Countries

United States

Contacts

Primary ContactLaura Ruebush, PhD
le.ruebush@ctral.org979-422-1789
Backup ContactMarielle Engelen, PhD
mpkj.engelen@ctral.org979-422-1789

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026