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Conséquences métaboliques et fonctionnelles du vieillissement de la santé et de la maladie

30 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Texas
      • College Station, Texas, États-Unis, 77845
        • Recrutement
        • Human Clinical Research Building
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

50 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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
Autre: Stable tracer infusion in a postabsorptive state

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

Autres noms:
  • Infusion de traceur stable

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Age-related changes in whole-body protein and amino acid metabolism
Délai: 2 hours

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Age-related changes in whole-body glucose metabolism
Délai: 2 hours

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

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

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

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

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

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

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

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

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

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

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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Age-related changes in hand dexterity
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Texas A&M University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 mars 2022

Achèvement primaire (Estimé)

1 septembre 2028

Achèvement de l'étude (Estimé)

1 septembre 2028

Dates d'inscription aux études

Première soumission

19 janvier 2022

Première soumission répondant aux critères de contrôle qualité

14 février 2022

Première publication (Réel)

15 février 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2021-1413
  • 82-Aging (Autre identifiant: CTRAL)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime 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).

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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