Metabolic and Functional Consequences of Aging in Health and Disease
14. Februar 2022 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
100
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Laura Ruebush, PhD
- Telefonnummer: 979-422-1789
- E-Mail: le.ruebush@ctral.org
Studieren Sie die Kontaktsicherung
- Name: Marielle Engelen, PhD
- Telefonnummer: 979-422-1789
- E-Mail: mpkj.engelen@ctral.org
Studienorte
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Texas
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College Station, Texas, Vereinigte Staaten, 77845
- Human Clinical Research Building
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Kontakt:
- Laura Ruebush, PhD
- E-Mail: le.ruebush@ctral.org
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
50 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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
- 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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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 |
Multiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Age-related changes in whole-body protein and amino acid metabolism
Zeitfenster: 2 hours
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Whole-body production rate measured after stable tracer administration
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2 hours
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Age-related changes in whole-body glucose metabolism
Zeitfenster: 2 hours
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Whole-body production rate measured after stable tracer administration
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2 hours
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Age-related changes in whole-body fat metabolism
Zeitfenster: 2 hours
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Whole-body production rate measured after stable tracer administration
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2 hours
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Age-related changes in depression as measured by the Hospital Anxiety and Depression Scale (HADS) and Geriatric Depression Scale (if applicable)
Zeitfenster: baseline visit
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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).
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baseline visit
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Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
Zeitfenster: baseline visit
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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).
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baseline visit
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Age-related changes in mood as measured by the Profile of Mood State (POMS)
Zeitfenster: baseline visit
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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.
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baseline visit
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Age-related changes in health status
Zeitfenster: baseline visit
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Health status assessed by Health-Related Quality of Life Scale (HR-QoL)
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baseline visit
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Age-related changes in physical activity
Zeitfenster: baseline visit
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Physical activity assessed by Physical Activity Scale for the Elderly (PASE)
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baseline visit
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Age-related changes in sleep quality
Zeitfenster: baseline visit
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Sleep quality assessed by Pittsburgh Sleep Quality Index
|
baseline visit
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Age-related changes in nutritional status
Zeitfenster: baseline visit
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Nutritional status assessed by Mini-Nutritional Assessment
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baseline visit
|
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Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)
Zeitfenster: baseline visit
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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.
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baseline visit
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Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
Zeitfenster: baseline visit
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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.
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baseline visit
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Age-related changes in exercise capacity
Zeitfenster: baseline visit
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Functional exercise capacity assessed by 6-minute walk test
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baseline visit
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Age-related changes in physical weakness (frailty)
Zeitfenster: baseline visit
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Physical weakness assessed by Short Physical Performance Battery
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baseline visit
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Age-related changes in skeletal muscle strength of the upper extremity
Zeitfenster: baseline visit
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Skeletal muscle strength measured by handgrip test
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baseline visit
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Age-related changes in skeletal muscle strength of the lower extremity
Zeitfenster: baseline visit
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Skeletal muscle strength measured by one-leg test
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baseline visit
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Age-related changes in respiratory muscle strength
Zeitfenster: baseline visit
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Respiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM)
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baseline visit
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Age-related changes in balance
Zeitfenster: baseline visit
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Skeletal muscle strength measured by Berg Balance Scale and balance platform
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baseline visit
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Age-related changes in gut microbiota
Zeitfenster: baseline visit
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The amount and types of microbiota assessed in collected stool sample
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baseline visit
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Age-related changes in gut function
Zeitfenster: baseline visit
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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).
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baseline visit
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Age-related changes in hand dexterity
Zeitfenster: baseline visit
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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.
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baseline visit
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Voraussichtlich)
1. März 2022
Primärer Abschluss (Voraussichtlich)
1. Februar 2025
Studienabschluss (Voraussichtlich)
1. Dezember 2025
Studienanmeldedaten
Zuerst eingereicht
19. Januar 2022
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Februar 2022
Zuerst gepostet (Tatsächlich)
15. Februar 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Februar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. Februar 2022
Zuletzt verifiziert
1. Februar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2021-1413
- 82-Aging (Andere Kennung: CTRAL)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Beschreibung des IPD-Plans
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).
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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