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Conseguenze metaboliche e funzionali dell'invecchiamento nella salute e nelle malattie

30 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Stati Uniti
    • Texas
      • College Station, Texas, Stati Uniti, 77845
        • Reclutamento
        • Human Clinical Research Building
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

50 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Altro: Stable tracer infusion in a postabsorptive state

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

Altri nomi:
  • Infusione di tracciante stabile

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Age-related changes in whole-body protein and amino acid metabolism
Lasso di tempo: 2 hours

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Age-related changes in whole-body glucose metabolism
Lasso di tempo: 2 hours

Whole-body production rate measured after stable tracer administration
2 hours
Age-related changes in whole-body fat metabolism
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: baseline visit

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

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

Sleep quality assessed by Pittsburgh Sleep Quality Index
baseline visit
Age-related changes in nutritional status
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: baseline visit

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

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

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

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

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

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

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Age-related changes in hand dexterity
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Texas A&M University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 marzo 2022

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2028

Date di iscrizione allo studio

Primo inviato

19 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

14 febbraio 2022

Primo Inserito (Effettivo)

15 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2021-1413
  • 82-Aging (Altro identificatore: CTRAL)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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).

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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