Metabolic and Functional Consequences of Aging in Health and Disease
2022年2月14日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Laura Ruebush, PhD
- 電話番号：979-422-1789
- メール：le.ruebush@ctral.org
研究連絡先のバックアップ
- 名前：Marielle Engelen, PhD
- 電話番号：979-422-1789
- メール：mpkj.engelen@ctral.org
研究場所
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Texas
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College Station、Texas、アメリカ、77845
- Human Clinical Research Building
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コンタクト：
- Laura Ruebush, PhD
- メール：le.ruebush@ctral.org
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Age-related changes in whole-body protein and amino acid metabolism
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Age-related changes in whole-body glucose metabolism
時間枠：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
時間枠：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)
時間枠：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).
|
baseline visit
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Age-related changes in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS)
時間枠：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).
|
baseline visit
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Age-related changes in mood as measured by the Profile of Mood State (POMS)
時間枠：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
時間枠：baseline visit
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Health status assessed by Health-Related Quality of Life Scale (HR-QoL)
|
baseline visit
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Age-related changes in physical activity
時間枠：baseline visit
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Physical activity assessed by Physical Activity Scale for the Elderly (PASE)
|
baseline visit
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Age-related changes in sleep quality
時間枠：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
時間枠：baseline visit
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Nutritional status assessed by Mini-Nutritional Assessment
|
baseline visit
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Age-related changes in attention and executive functions as measured by Trail Making Test (TMT)
時間枠：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.
|
baseline visit
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Age-related changes in overall cognitive abilities as measured by Montreal Cognitive Assessment (MoCA)
時間枠：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.
|
baseline visit
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Age-related changes in exercise capacity
時間枠：baseline visit
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Functional exercise capacity assessed by 6-minute walk test
|
baseline visit
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Age-related changes in physical weakness (frailty)
時間枠：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
時間枠：baseline visit
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Skeletal muscle strength measured by handgrip test
|
baseline visit
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Age-related changes in skeletal muscle strength of the lower extremity
時間枠：baseline visit
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Skeletal muscle strength measured by one-leg test
|
baseline visit
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Age-related changes in respiratory muscle strength
時間枠：baseline visit
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Respiratory muscle strength measured by a hand-held mouth pressure device (Micro RPM)
|
baseline visit
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Age-related changes in balance
時間枠：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
時間枠：baseline visit
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The amount and types of microbiota assessed in collected stool sample
|
baseline visit
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Age-related changes in gut function
時間枠：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).
|
baseline visit
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Age-related changes in hand dexterity
時間枠：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.
|
baseline visit
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2022年3月1日
一次修了 (予想される)
2025年2月1日
研究の完了 (予想される)
2025年12月1日
試験登録日
最初に提出
2022年1月19日
QC基準を満たした最初の提出物
2022年2月14日
最初の投稿 (実際)
2022年2月15日
学習記録の更新
投稿された最後の更新 (実際)
2022年2月15日
QC基準を満たした最後の更新が送信されました
2022年2月14日
最終確認日
2022年2月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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).
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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