Metabolic and Functional Consequences of Aging in Health and Disease

NCT05240885 | Recruiting

• 2 other identifiers: 2021-141382-Aging
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

stable isotopes; disease; metabolism

Outcome Measures

Primary Outcomes (1)

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

  Whole-body production rate measured after stable tracer administration

  2 hours

Secondary Outcomes (19)

• Age-related changes in whole-body glucose metabolism

  2 hours

• Age-related changes in whole-body fat metabolism

  2 hours

• 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 anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)

  baseline visit

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

  baseline visit

Other Outcomes (1)

• Age-related changes in hand dexterity

  baseline visit

Study Arms (1)

Controls

Study subjects that are eligible based on inclusion/exclusion criteria Screening visit: body weight and composition by DXA, height, and vital signs will be assessed. Study day(s): may include combinations of stable tracer infusions and with blood draws, cognitive and muscle performance testing

Other: Stable tracer infusion in a postabsorptive state

Interventions

Stable tracer infusion in a postabsorptive state OTHER

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

Also known as: Stable tracer infusion

Controls

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Human Clinical Research Building

College Station, Texas, 77845, United States

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura Ruebush, PhD

CONTACT

979-422-1789; le.ruebush@ctral.org

Marielle Engelen, PhD

CONTACT

979-422-1789; mpkj.engelen@ctral.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chancellor Edges Fellow

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 15, 2022
• Study Start: March 4, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)