Metabolic and Functional Consequences of Aging in Health and Disease
14. februar 2022 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
Ikke rekrutterer endnu
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 (Forventet)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Laura Ruebush, PhD
- Telefonnummer: 979-422-1789
- E-mail: le.ruebush@ctral.org
Undersøgelse Kontakt Backup
- Navn: Marielle Engelen, PhD
- Telefonnummer: 979-422-1789
- E-mail: mpkj.engelen@ctral.org
Studiesteder
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Texas
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College Station, Texas, Forenede Stater, 77845
- Human Clinical Research Building
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Kontakt:
- Laura Ruebush, PhD
- E-mail: le.ruebush@ctral.org
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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 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.
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
- 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
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 |
Multiple stable-labeled tracers of amino acids, ketoacids, glycerol, short-chain fatty acids
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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 (Forventet)
1. marts 2022
Primær færdiggørelse (Forventet)
1. februar 2025
Studieafslutning (Forventet)
1. december 2025
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)
15. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
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
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