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Recruiting NCT05240885

Metabolic and Functional Consequences of Aging in Health and Disease

— Observational Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stable tracer infusion in a postabsorptive state.
Who it may be relevant to
Registry conditions: Aging. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Stable tracer infusion in a postabsorptive state
    Multiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids

Primary outcome measures

  • Age-related changes in whole-body protein and amino acid metabolism [Time frame: 2 hours]
Secondary outcome measures (12)
  • Age-related changes in whole-body glucose metabolism [Time frame: 2 hours]
  • Age-related changes in whole-body fat metabolism [Time frame: 2 hours]
  • 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]
  • Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) [Time frame: baseline visit]
  • Age-related changes in mood as measured by the Profile of Mood State (POMS) [Time frame: baseline visit]
  • Age-related changes in health status [Time frame: baseline visit]
  • Age-related changes in physical activity [Time frame: baseline visit]
  • Age-related changes in sleep quality [Time frame: baseline visit]
  • Age-related changes in nutritional status [Time frame: baseline visit]
  • Age-related changes in attention and executive functions as measured by Trail Making Test (TMT) [Time frame: baseline visit]
  • Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA) [Time frame: baseline visit]
  • Age-related changes in exercise capacity [Time frame: baseline visit]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Human Clinical Research Building — College Station

Publications

  • Huttl VN, Deutz N, Wierzchowska-McNew RA, Ruebush LE, Engelen M. Whole-body and intracellular arginine metabolism in hypertension: role of disease severity and sex. Am J Hypertens. 2026 May 18:hpag047. doi: 10.1093/ajh/hpag047. Online ahead of print. PMID 42149813

Identifiers

NCT: NCT05240885 · 2021-1413 · 82-Aging

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗