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Metaboliske og funktionelle konsekvenser af aldring i sundhed og sygdom

30. september 2026 opdateret af: Marielle PKJ Engelen, PhD, Texas A&M University

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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
  • 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

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
Andet: Stable tracer infusion in a postabsorptive state

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

Andre navne:
  • Stabil sporingsinfusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Age-related changes in whole-body protein and amino acid metabolism
Tidsramme: 2 hours

Whole-body production rate measured after stable tracer administration
2 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Age-related changes in whole-body glucose metabolism
Tidsramme: 2 hours

Whole-body production rate measured after stable tracer administration
2 hours
Age-related changes in whole-body fat metabolism
Tidsramme: 2 hours

Whole-body production rate measured after stable tracer administration
2 hours
Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)
Tidsramme: baseline visit

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).
baseline visit
Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
Tidsramme: baseline visit

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).
baseline visit
Age-related changes in mood as measured by the Profile of Mood State (POMS)
Tidsramme: baseline visit

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.
baseline visit
Age-related changes in health status
Tidsramme: baseline visit

Health status assessed by Health-Related Quality of Life Scale (HR-QoL)
baseline visit
Age-related changes in physical activity
Tidsramme: baseline visit

Physical activity assessed by Physical Activity Scale for the Elderly (PASE)
baseline visit
Age-related changes in sleep quality
Tidsramme: baseline visit

Sleep quality assessed by Pittsburgh Sleep Quality Index
baseline visit
Age-related changes in nutritional status
Tidsramme: baseline visit

Nutritional status assessed by Mini-Nutritional Assessment
baseline visit
Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)
Tidsramme: baseline visit

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.
baseline visit
Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Tidsramme: baseline visit

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.
baseline visit
Age-related changes in exercise capacity
Tidsramme: baseline visit

Functional exercise capacity assessed by 6-minute walk test
baseline visit
Age-related changes in physical weakness (frailty)
Tidsramme: baseline visit

Physical weakness assessed by Short Physical Performance Battery
baseline visit
Age-related changes in skeletal muscle strength of the upper extremity
Tidsramme: baseline visit

Skeletal muscle strength measured by handgrip test
baseline visit
Age-related changes in skeletal muscle strength of the lower extremity
Tidsramme: baseline visit

Skeletal muscle strength measured by one-leg test
baseline visit
Age-related changes in respiratory muscle strength
Tidsramme: baseline visit

Respiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM)
baseline visit
Age-related changes in balance
Tidsramme: baseline visit

Skeletal muscle strength measured by Berg Balance Scale and balance platform
baseline visit
Age-related changes in gut microbiota
Tidsramme: baseline visit

The amount and types of microbiota assessed in collected stool sample
baseline visit
Age-related changes in gut function
Tidsramme: baseline visit

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).
baseline visit

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Age-related changes in hand dexterity
Tidsramme: baseline visit

Hand dexterity assessed by the Nine-Hole Peg Test (9-HPT), a standardized, quantitative assessment in which the subject is asked to take pegs from a container, one by one, and place them into the holes on the board. Time upon completion will be recorded using both left and right hand, separately.
baseline visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Texas A&M University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. marts 2022

Primær færdiggørelse (Anslået)

1. september 2028

Studieafslutning (Anslået)

1. september 2028

Datoer for studieregistrering

Først indsendt

19. januar 2022

Først indsendt, der opfyldte QC-kriterier

14. februar 2022

Først opslået (Faktiske)

15. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-1413
  • 82-Aging (Anden identifikator: CTRAL)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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