Clinical trial NCT05240885: Metabolic and Functional Consequences of Aging in Health and Disease
Official title: Metabolic and Functional Consequences of Aging in Health and Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aging
Keywords: stable isotopes
disease
metabolism
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will screen 200 subjects (to complete n=100). 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.

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.

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

Primary outcomes:
measure: Age-related changes in whole-body protein and amino acid metabolism
timeFrame: 2 hours
Secondary outcomes:
measure: Age-related changes in whole-body glucose metabolism
timeFrame: 2 hours
measure: Age-related changes in whole-body fat metabolism
timeFrame: 2 hours
measure: Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)
timeFrame: baseline visit
measure: Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline visit
measure: Age-related changes in mood as measured by the Profile of Mood State (POMS)
timeFrame: baseline visit
measure: Age-related changes in health status
timeFrame: baseline visit
measure: Age-related changes in physical activity
timeFrame: baseline visit
measure: Age-related changes in sleep quality
timeFrame: baseline visit
measure: Age-related changes in nutritional status
timeFrame: baseline visit
measure: Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)
timeFrame: baseline visit
measure: Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
timeFrame: baseline visit
measure: Age-related changes in exercise capacity
timeFrame: baseline visit
measure: Age-related changes in physical weakness (frailty)
timeFrame: baseline visit
measure: Age-related changes in skeletal muscle strength of the upper extremity
timeFrame: baseline visit
measure: Age-related changes in skeletal muscle strength of the lower extremity
timeFrame: baseline visit
measure: Age-related changes in respiratory muscle strength
timeFrame: baseline visit
measure: Age-related changes in balance
timeFrame: baseline visit
measure: Age-related changes in gut microbiota
timeFrame: baseline visit
measure: Age-related changes in gut function
timeFrame: baseline visit
Other outcomes:
measure: Age-related changes in hand dexterity
timeFrame: baseline visit
Locations:
city: College Station
country: United States
facility: Human Clinical Research Building
state: Texas
Study officials:
References: