AgingNCT05240885
Metabolic and Functional Consequences of Aging in Health and Disease
An observational study of Aging, run by Texas A&M University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Stable tracer infusion in a postabsorptive state
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will screen 400 subjects (to complete n=320). 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.
Who may be able to join
- 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
- Discharged within 30 days after a hospital admittance for >48-hours (recently hospitalized group only)
- Diagnosis of heart failure (stages 2-4 heart failure based on the New York Heart Association Functional Class; heart failure group only)
- Willingness and ability to comply with the protocol
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Human Clinical Research Building
College Station, Texas, 77845
Laura Ruebush, PhD, le.ruebush@ctral.org
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Stable tracer infusion in a postabsorptive state
- Keywords
- stable isotopes, disease, metabolism
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable tracer infusion in a postabsorptive stateOther
Also called Stable tracer infusion
Multiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Stable tracer infusion in a postabsorptive state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age-related changes in whole-body protein and amino acid metabolism
Whole-body production rate measured after stable tracer administration
Measured: 2 hours
Secondary outcomes (19)
Age-related changes in whole-body glucose metabolism
Whole-body production rate measured after stable tracer administration
Measured: 2 hours
Age-related changes in whole-body fat metabolism
Whole-body production rate measured after stable tracer administration
Measured: 2 hours
Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)
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).
Measured: baseline visit
Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
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).
Measured: baseline visit
Age-related changes in mood as measured by the Profile of Mood State (POMS)
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.
Measured: baseline visit
Age-related changes in health status
Health status assessed by Health-Related Quality of Life Scale (HR-QoL)
Measured: baseline visit
Age-related changes in physical activity
Physical activity assessed by Physical Activity Scale for the Elderly (PASE)
Measured: baseline visit
Age-related changes in sleep quality
Sleep quality assessed by Pittsburgh Sleep Quality Index
Measured: baseline visit
Age-related changes in nutritional status
Nutritional status assessed by Mini-Nutritional Assessment
Measured: baseline visit
Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)
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.
Measured: baseline visit
Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
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.
Measured: baseline visit
Age-related changes in exercise capacity
Functional exercise capacity assessed by 6-minute walk test
Measured: baseline visit
Age-related changes in physical weakness (frailty)
Physical weakness assessed by Short Physical Performance Battery
Measured: baseline visit
Age-related changes in skeletal muscle strength of the upper extremity
Skeletal muscle strength measured by handgrip test
Measured: baseline visit
Age-related changes in skeletal muscle strength of the lower extremity
Skeletal muscle strength measured by one-leg test
Measured: baseline visit
Age-related changes in respiratory muscle strength
Respiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM)
Measured: baseline visit
Age-related changes in balance
Skeletal muscle strength measured by Berg Balance Scale and balance platform
Measured: baseline visit
Age-related changes in gut microbiota
The amount and types of microbiota assessed in collected stool sample
Measured: baseline visit
Age-related changes in gut function
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).
Measured: baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start4 Mar 2022
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240885
- Sponsor's protocol ID
- 2021-1413
- Other IDs
- 82-Aging
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared upon request for up to 6 years beyond completion of the trial based on methods/proposal approved by both parties' institutional review committees. Individual participant data that underlie the results of the trial may be shared after de-identification (text, tables, figures, and appendices). Additional documents available per request include: study protocol, statistical analysis plan, and informed consent. Requests should be directed to Dr. Marielle Engelen (mpkj.engelen@ctral.org).
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.
PubMed 42149813
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic and Functional Consequences of Aging in Health and Disease
- ClinicalTrials.gov ID
- NCT05240885
- Acronym / sponsor ID
- 2021-1413
- Conditions
- Aging
- Keywords
- stable isotopes, disease, metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Other: Stable tracer infusion in a postabsorptive stateStudy 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will screen 400 subjects (to complete n=320). 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.
Key inclusion criteria (7 listed)
- 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
- Discharged within 30 days after a hospital admittance for >48-hours (recently hospitalized group only)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable tracer infusion in a postabsorptive stateAlso: Stable tracer infusionMultiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids | Other | Controls |
Primary outcome
Age-related changes in whole-body protein and amino acid metabolism
Time frame: 2 hours
Whole-body production rate measured after stable tracer administration
19 secondary outcomes
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
Age-related changes in physical weakness (frailty)
Time frame: baseline visit
Age-related changes in skeletal muscle strength of the upper extremity
Time frame: baseline visit
Age-related changes in skeletal muscle strength of the lower extremity
Time frame: baseline visit
Age-related changes in respiratory muscle strength
Time frame: baseline visit
Age-related changes in balance
Time frame: baseline visit
Age-related changes in gut microbiota
Time frame: baseline visit
Age-related changes in gut function
Time frame: baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 42149813Huttl 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.
- Individual participant dataSharing planned: Undecided. Data may be shared upon request for up to 6 years beyond completion of the trial based on methods/proposal approved by both parties' institutional review committees. Individual participant data that underlie the results of the trial may be shared after de-identification (text, tables, figures, and appendices). Additional documents available per request include: study protocol, statistical analysis plan, and informed consent. Requests should be directed to Dr. Marielle Engelen (mpkj.engelen@ctral.org).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Ruebush, PhD (979-422-1789, le.ruebush@ctral.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age-related changes in whole-body protein and amino acid metabolism (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05240885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.