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Clinical Trials/NCT05240885
NCT05240885
Recruiting
N/A

Metabolic and Functional Consequences of Aging in Health and Disease

Texas A&M University1 site in 1 country100 target enrollmentMarch 4, 2022
ConditionsAging

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aging
Sponsor
Texas A&M University
Enrollment
100
Locations
1
Primary Endpoint
Age-related changes in whole-body protein and amino acid metabolism
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2022
End Date
September 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marielle PKJ Engelen, PhD

Professor & Chancellor Edges Fellow

Texas A&M University

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

Outcomes

Primary Outcomes

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

  • Age-related changes in whole-body fat metabolism(2 hours)
  • Age-related changes in sleep quality(baseline visit)
  • Age-related changes in gut function(baseline visit)
  • Age-related changes in physical weakness (frailty)(baseline visit)
  • Age-related changes in mood as measured by the Profile of Mood State (POMS)(baseline visit)
  • Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)(baseline visit)
  • Age-related changes in exercise capacity(baseline visit)
  • Age-related changes in balance(baseline visit)
  • Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)(baseline visit)
  • Age-related changes in physical activity(baseline visit)
  • Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)(baseline visit)
  • Age-related changes in skeletal muscle strength of the upper extremity(baseline visit)
  • Age-related changes in whole-body glucose metabolism(2 hours)
  • Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)(baseline visit)
  • Age-related changes in health status(baseline visit)
  • Age-related changes in nutritional status(baseline visit)
  • Age-related changes in skeletal muscle strength of the lower extremity(baseline visit)
  • Age-related changes in respiratory muscle strength(baseline visit)
  • Age-related changes in gut microbiota(baseline visit)

Study Sites (1)

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