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NCT Number: NCT05240885

Metabolic and Functional Consequences of Aging in Health and Disease

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.

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Key information

Conditions

Aging Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Human Clinical Research Building

College Station, Texas, 77845, United States

Location status: Recruiting

Location contact

Laura Ruebush, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stable tracer infusion in a postabsorptive state

Other

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

Other names: Stable tracer infusion

Primary outcomes

  1. Age-related changes in whole-body protein and amino acid metabolism

    Time frame: 2 hours

    Whole-body production rate measured after stable tracer administration

Secondary outcomes

  1. Age-related changes in whole-body glucose metabolism

    Time frame: 2 hours

    Whole-body production rate measured after stable tracer administration

  2. Age-related changes in whole-body fat metabolism

    Time frame: 2 hours

    Whole-body production rate measured after stable tracer administration

  3. Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)

    Time frame: baseline visit

    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).

  4. Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: baseline visit

    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).

  5. Age-related changes in mood as measured by the Profile of Mood State (POMS)

    Time frame: baseline visit

    A 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.

  6. Age-related changes in health status

    Time frame: baseline visit

    Health status assessed by Health-Related Quality of Life Scale (HR-QoL)

  7. Age-related changes in physical activity

    Time frame: baseline visit

    Physical activity assessed by Physical Activity Scale for the Elderly (PASE)

  8. Age-related changes in sleep quality

    Time frame: baseline visit

    Sleep quality assessed by Pittsburgh Sleep Quality Index

  9. Age-related changes in nutritional status

    Time frame: baseline visit

    Nutritional status assessed by Mini-Nutritional Assessment

  10. Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)

    Time frame: baseline visit

    In 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.

  11. Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)

    Time frame: baseline visit

    MoCa 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.

  12. Age-related changes in exercise capacity

    Time frame: baseline visit

    Functional exercise capacity assessed by 6-minute walk test

  13. Age-related changes in physical weakness (frailty)

    Time frame: baseline visit

    Physical weakness assessed by Short Physical Performance Battery

  14. Age-related changes in skeletal muscle strength of the upper extremity

    Time frame: baseline visit

    Skeletal muscle strength measured by handgrip test

  15. Age-related changes in skeletal muscle strength of the lower extremity

    Time frame: baseline visit

    Skeletal muscle strength measured by one-leg test

  16. Age-related changes in respiratory muscle strength

    Time frame: baseline visit

    Respiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM)

  17. Age-related changes in balance

    Time frame: baseline visit

    Skeletal muscle strength measured by Berg Balance Scale and balance platform

  18. Age-related changes in gut microbiota

    Time frame: baseline visit

    The amount and types of microbiota assessed in collected stool sample

  19. Age-related changes in gut function

    Time frame: baseline visit

    Gut 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).

Other outcomes

  1. Age-related changes in hand dexterity

    Time frame: baseline visit

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Ruebush, PhD

CONTACT

[email protected]

979-422-1789

Marielle Engelen, PhD

CONTACT

[email protected]

979-422-1789

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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