CALERIE™レガシー研究
2026年6月5日 更新者：Sai Krupa Das、Tufts University
健康寿命と老化の特徴に対する 2 年間のカロリー制限介入である CALERIE™ のレガシー効果
CALERIE Legacy Study の目的は、2007 年から 2011 年にかけて実施されたエネルギー摂取量削減の長期的影響の包括的評価 (CALERIE) 試験のフェーズ 2 から参加者の健康状態を追跡することです。
調査の概要
状態
積極的、募集していない
条件
詳細な説明
CALERIE Legacy Study は、第 2 相 CALERIE 試験の参加者の観察追跡調査であり、肥満のないヒトにおけるカロリー制限 (CR) の最初のランダム化比較試験です。
CALERIE Legacy Study の最も重要な目標は、2 年間の CR が、構造的介入の 10 年から 15 年後のヒト老化の生物学的、表現型、および機能的特徴の持続的な改善をもたらすかどうかを調べることです。
参加者は、臨床評価、食事のリコール、およびアンケートを完了し、検査室での評価が血液と尿のサンプルで実行されます。
この研究には、オプションの生体試料保管コンポーネントも含まれています。
研究の種類
観察的
入学 (推定)
216
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。
研究場所
-
-
Louisiana
-
Baton Rouge、Louisiana、アメリカ、70808
- Pennington Biomedical Research Center
-
-
Massachusetts
-
Boston、Massachusetts、アメリカ、02111
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110-1010
- Washington University School of Medicine
-
-
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
33年～70年 (大人、高齢者)
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
亡くなった人を除くすべての CALERIE 参加者は、資格がないことがわかっているか、割り当てられたグループ (CR 介入またはアドリビタム コントロール) を開始しなかった (n = 4) であり、潜在的な被験者として特定されています (n = 216)。 CALERIEレガシースタディ。
この研究の人口統計学的プロファイルは、70.4% が女性であった CALERIE 試験のプロファイルと同様であると予想されます。
性別、人種、民族を問わず、肥満のない健康な人が CALERIE 試験に参加する資格がありました。
ただし、安全上の懸念から妊娠中の女性は除外され、閉経前後の状態との交絡を避けるために、女性の年齢の上限は 47 歳でした。
登録時の CALERIE 参加者は 20 ～ 50 歳で、白人が 77.3%、黒人が 12%、その他が 10.7% でした。民族性は 97% が非ヒスパニックでした。
説明
包含基準:
- CALERIE 試験に登録し、割り当てられたグループを開始した (CR 介入または自由制御条件)
- -対面での訪問のために臨床施設の1つに参加する意思と能力があり、インフォームドコンセントを提供します
除外基準:
- 妊娠中の女性
- 産後12ヶ月未満の女性
- 被験者に連絡してはならない、または将来の研究のために連絡しないように要求してはならないことを示すCALERIE試験からの文書化されたメモ
- 進行中のがんまたは末期疾患と診断されている
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
- 観測モデル：ケースコントロール
- 時間の展望：他の
コホートと介入
グループ/コホート |
|---|
|
カロリー制限 (CR)
CR グループの個人は、2 年間の CALERIE 試験中に、ベースラインのエネルギー摂取量から 25% の削減を処方されました。
|
|
アドリビタム (AL)
AL グループの個人は、2 年間の CALERIE 試験の間、通常の食事摂取を続けるよう求められました。
|
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 |
|---|---|---|
|
Biological age - Klemera-Doubal Method
時間枠：11-16 years post CALERIE trial
|
Biological age will be quantified by the Klemera-Doubal Method (KDM), an algorithm-based measure.
Biological age is expressed in years.
|
11-16 years post CALERIE trial
|
|
Healthspan
時間枠：11-16 years post CALERIE trial
|
Healthspan will be assessed by sex-specific metabolic syndrome z-score (MS z-score). MS z-score was developed using high density lipoprotein cholesterol (HDL), triglycerides (TG), waist circumference (WC), fasting blood glucose (FBG), and mean arterial pressure (MAP = [systolic blood pressure + 2 x diastolic blood pressure]/3). SDs for HDL and WC in the equations are sex specific. Women: MS z-score = [45-HDL]/SDHDLW+ [TG-150]/SDTG + [WC-88]/SDWCW + [FBG-100]/SDFBG + [MAP -100]/SDMAP Men: MS z-score = [40-HDL]/SDHDLM+ [TG-150]/SDTG + [WC-102]/SDWCM + [FBG-100]/SDFBG + [MAP -100]/SDMAP W = women M = men This score does not have a unit. |
11-16 years post CALERIE trial
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Biological age - Homeostatic Dysregulation
時間枠：11-16 years post CALERIE trial
|
Biological age will be quantified by homeostatic dysregulation, an algorithm-based measure.
Biological age is expressed in years.
|
11-16 years post CALERIE trial
|
|
Biological age - Levine Phenotypic Age
時間枠：11-16 years post CALERIE trial
|
Biological age will be quantified by Levine Phenotypic Age, an algorithm-based measure.
Biological age is expressed in years.
|
11-16 years post CALERIE trial
|
|
Height
時間枠：11-16 years post CALERIE trial
|
Height will be measured in cm.
|
11-16 years post CALERIE trial
|
|
Weight
時間枠：11-16 years post CALERIE trial
|
Weight will be measured in kg.
|
11-16 years post CALERIE trial
|
|
Waist circumference
時間枠：11-16 years post CALERIE trial
|
Weight circumference will be measured in cm.
|
11-16 years post CALERIE trial
|
|
Hip circumference
時間枠：11-16 years post CALERIE trial
|
Hip circumference will be measured in cm.
|
11-16 years post CALERIE trial
|
|
Body mass index (BMI)
時間枠：11-16 years post CALERIE trial
|
BMI (kg/m2) will be calculated using height and weight measurements.
|
11-16 years post CALERIE trial
|
|
Blood pressure
時間枠：11-16 years post CALERIE trial
|
Systolic and diastolic blood pressure will be measured in mmHg.
|
11-16 years post CALERIE trial
|
|
Pulse rate at rest
時間枠：11-16 years post CALERIE trial
|
Pulse rate will be measured in beats/min.
|
11-16 years post CALERIE trial
|
|
Respiration rate at rest
時間枠：11-16 years post CALERIE trial
|
Respiration rate will be measured in breaths/min.
|
11-16 years post CALERIE trial
|
|
Fat mass
時間枠：11-16 years post CALERIE trial
|
Whole-body fat mass (kg, %) as measured by dual-energy X-ray absorptiometry.
|
11-16 years post CALERIE trial
|
|
Fat-free mass
時間枠：11-16 years post CALERIE trial
|
Whole-body fat-free mass (kg, %) as measured by dual-energy X-ray absorptiometry.
|
11-16 years post CALERIE trial
|
|
Bone mineral content
時間枠：11-16 years post CALERIE trial
|
Whole-body bone mineral content (g) as measured by dual-energy X-ray absorptiometry.
|
11-16 years post CALERIE trial
|
|
Resting metabolic rate (RMR)
時間枠：11-16 years post CALERIE trial
|
RMR will be measured in kcal/d by indirect calorimetry using a ventilated hood system.
|
11-16 years post CALERIE trial
|
|
Respiratory quotient (RQ)
時間枠：11-16 years post CALERIE trial
|
RQ will be measured by indirect calorimetry using a ventilated hood system.
This is a ratio (V̇CO2/V̇O2) and does not have a unit.
|
11-16 years post CALERIE trial
|
|
Maximal aerobic capacity (V̇O2max)
時間枠：11-16 years post CALERIE trial
|
Maximal aerobic capacity (V̇O2max) will be measured in mL/kg/min using the Cornell incremental treadmill test.
|
11-16 years post CALERIE trial
|
|
Interleukin-6 (IL-6)
時間枠：11-16 years post CALERIE trial
|
IL-6, a blood-based biomarker of aging proposed by the Targeting Aging with MEtformin (TAME) Biomarkers Workgroup, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Insulin - TAME panel
時間枠：11-16 years post CALERIE trial
|
Insulin, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in μIU/mL.
|
11-16 years post CALERIE trial
|
|
Insulin - 0 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Insulin (μIU/mL) will be measured at 0 minutes (pre-dose) during an oral glucose tolerance test (OGTT) to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Insulin - 30 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Insulin (μIU/mL) will be measured at 30 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Insulin - 60 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Insulin (μIU/mL) will be measured at 60 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Insulin - 90 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Insulin (μIU/mL) will be measured at 90 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Insulin - 120 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Insulin (μIU/mL) will be measured at 120 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Insulin-like growth factor 1 (IGF-1)
時間枠：11-16 years post CALERIE trial
|
IGF-1, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Hemoglobin A1c (HbA1c)
時間枠：11-16 years post CALERIE trial
|
HbA1c, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in mmol/mol.
|
11-16 years post CALERIE trial
|
|
Tumor necrosis factor α receptor II (TNFRII)
時間枠：11-16 years post CALERIE trial
|
TNFRII, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
High-sensitivity C-reactive protein (hsCRP)
時間枠：11-16 years post CALERIE trial
|
hsCRP, a blood-based biomarker of inflammation, will be measured in μg/mL.
|
11-16 years post CALERIE trial
|
|
Growth/differentiation factor 15 (GDF15)
時間枠：11-16 years post CALERIE trial
|
GDF15, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Cystatin C
時間枠：11-16 years post CALERIE trial
|
Cystatin C, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in mg/L.
|
11-16 years post CALERIE trial
|
|
N-terminal B-type natriuretic peptide (NT-proBNP)
時間枠：11-16 years post CALERIE trial
|
NT-proBNP, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Senescence-associated secretory phenotype (SASP) proteins
時間枠：11-16 years post CALERIE trial
|
SASP proteins, blood-based biomarkers of cellular senescence, will be measured using a SASP panel.
|
11-16 years post CALERIE trial
|
|
Urinary Isoprostanes - iPF(2α)-III
時間枠：11-16 years post CALERIE trial
|
Urinary iPF(2α)-III, a biomarker of systemic oxidative stress, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Urinary Isoprostanes - 2,3-dinor-iPF(2α)-III
時間枠：11-16 years post CALERIE trial
|
Urinary 2,3-dinor-iPF(2α)-III, a biomarker of systemic oxidative stress, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Urinary Isoprostanes - iPF(2α)-VI
時間枠：11-16 years post CALERIE trial
|
Urinary iPF(2α)-VI, a biomarker of systemic oxidative stress, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Urinary Isoprostanes - 8,12-iso-iPF(2α)-VI
時間枠：11-16 years post CALERIE trial
|
Urinary 8,12-iso-iPF(2α)-VI, a biomarker of systemic oxidative stress, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Creatinine
時間枠：11-16 years post CALERIE trial
|
Creatinine, a byproduct of routine activity in the muscle, will be measured in urine in mg/mL.
|
11-16 years post CALERIE trial
|
|
Dehydroepiandrosterone (DHEA)
時間枠：11-16 years post CALERIE trial
|
DHEA, a blood-based steroid hormone, will be measured in μg/dL.
|
11-16 years post CALERIE trial
|
|
Interleukin 1 beta (IL-1b)
時間枠：11-16 years post CALERIE trial
|
IL-1b, a blood-based marker of inflammation, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Interleukin 8 (IL-8)
時間枠：11-16 years post CALERIE trial
|
IL-8, a blood-based marker of inflammation, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Tumor necrosis factor α (TNF-α)
時間枠：11-16 years post CALERIE trial
|
TNF-α, a blood-based marker of inflammation, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Insulin-like growth factor-binding protein 1 (IGFBP-1)
時間枠：11-16 years post CALERIE trial
|
IGFBP-1, a blood-based transport protein, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Transforming growth factor beta 1 (TGFB1)
時間枠：11-16 years post CALERIE trial
|
TGFB1, a blood-based marker of immune function, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Insulin-like growth factor-binding protein 3 (IGFBP-3)
時間枠：11-16 years post CALERIE trial
|
IGFBP-3, a blood-based transport protein, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Platelet-derived growth factor-AB (PDGF-AB)
時間枠：11-16 years post CALERIE trial
|
PDGF-AB, a blood-based marker of cellular function, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Intercellular Adhesion Molecule 1 (ICAM-1)
時間枠：11-16 years post CALERIE trial
|
ICAM-1, a blood-based marker of inflammation, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Growth hormone
時間枠：11-16 years post CALERIE trial
|
Growth hormone, a blood-based bio-marker of cellular function, will be measured in ng/mL.
|
11-16 years post CALERIE trial
|
|
Monocyte Chemoattractant Protein 1 (MCP1)
時間枠：11-16 years post CALERIE trial
|
MCP1, a blood-based marker of inflammation, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Leptin
時間枠：11-16 years post CALERIE trial
|
Leptin, a hormonal regulator of energy balance, will be measured in pg/mL.
|
11-16 years post CALERIE trial
|
|
Total adiponectin
時間枠：11-16 years post CALERIE trial
|
Total adiponectin, a protein hormone that regulates several metabolic processes, including glucose regulation and fatty acid oxidation, will be measured in μg/mL.
|
11-16 years post CALERIE trial
|
|
High molecular weight adiponectin
時間枠：11-16 years post CALERIE trial
|
High molecular weight adiponectin, a protein hormone that regulates several metabolic processes, including glucose regulation and fatty acid oxidation, will be measured in μg/mL.
|
11-16 years post CALERIE trial
|
|
Muscle strength - Knee extension (60°)
時間枠：11-16 years post CALERIE trial
|
Knee extension at 60 degrees per second will be measured by isokinetic dynamometry and expressed in Nm.
|
11-16 years post CALERIE trial
|
|
Muscle strength - Knee extension (180°)
時間枠：11-16 years post CALERIE trial
|
Knee extension at 180 degrees per second will be measured by isokinetic dynamometry and expressed in Nm.
|
11-16 years post CALERIE trial
|
|
Muscle strength - Knee flexion (60°)
時間枠：11-16 years post CALERIE trial
|
Knee flexion at 60 degrees per second will be measured by isokinetic dynamometry and expressed in Nm.
|
11-16 years post CALERIE trial
|
|
Muscle strength - Knee flexion (180°)
時間枠：11-16 years post CALERIE trial
|
Knee flexion at 180 degrees per second will be measured by isokinetic dynamometry and expressed in Nm.
|
11-16 years post CALERIE trial
|
|
Handgrip Strength
時間枠：11-16 years post CALERIE trial
|
Handgrip strength will be measured via a hand dynamometer and expressed in kg.
|
11-16 years post CALERIE trial
|
|
Physical functioning
時間枠：11-16 years post CALERIE trial
|
Physical functioning as measured by a physical performance battery.
This physical performance battery provides a composite score ranging from 0 to 12 and includes results from the balance, gait and chair stand tests.
|
11-16 years post CALERIE trial
|
|
Cognition
時間枠：11-16 years post CALERIE trial
|
Cognition as measured by the Cambridge Neuropsychological Test Automated Battery (CANTAB).
The CANTAB evaluates six main areas of cognitive function: reaction time; verbal recognition memory; intra-extra dimensional set shift; rapid visual information processing; delayed matching to sample; and spatial working memory.
|
11-16 years post CALERIE trial
|
|
Dietary intake - calories
時間枠：11-16 years post CALERIE trial
|
Dietary intake in calories (kcals/day), as measured by multiple-pass 24-hour dietary recalls and Nutrition Data System for Research (NDSR) software.
|
11-16 years post CALERIE trial
|
|
Dietary intake - carbohydrates
時間枠：11-16 years post CALERIE trial
|
Dietary carbohydrates (grams and % of energy intake) will be measured by multiple-pass 24-hour dietary recalls and Nutrition Data System for Research (NDSR) software.
|
11-16 years post CALERIE trial
|
|
Dietary intake - proteins
時間枠：11-16 years post CALERIE trial
|
Dietary proteins (grams and % of energy intake) will be measured by multiple-pass 24-hour dietary recalls and Nutrition Data System for Research (NDSR) software.
|
11-16 years post CALERIE trial
|
|
Health-related quality of life
時間枠：11-16 years post CALERIE trial
|
Quality of life as measured by the RAND 36-Item Short Form Survey (SF-36).
The RAND SF-36 measures eight aspects of health: physical functioning, role limitations due to physical health problems, role limitations due to personal or emotional problems, energy/fatigue, emotional well-being, social functioning, bodily pain, and general health perceptions.
It also includes a single item that provides an indication of perceived change in health.
Each item is on a 3- or 5-point Likert scale (1-3 or 1-5).
Each response is transformed to a recoded value of 0-100, and the transformed scores of the 9 subscales are averaged to derive a composite score.
Higher scores indicate more favorable health states.
|
11-16 years post CALERIE trial
|
|
Depression status
時間枠：11-16 years post CALERIE trial
|
Depression status as measured by the Beck Depression Inventory II (BDI-II).
The 21-item BDI-II measures depression severity.
The score range is 0-63, with higher scores indicating greater depression severity.
Nineteen items are on a 4-point Likert scale (0-3).
Two items are on a 7-point Likert scale, and responses are scaled to 0-3.
The values are summed to calculate the total score.
|
11-16 years post CALERIE trial
|
|
Mood
時間枠：11-16 years post CALERIE trial
|
Mood as measured by the Profile of Mood States Second Edition (POMS 2).
The POMS 2 assesses six mood subscales using 65 items, each on a 5-point Likert scale (0-4): tension-anxiety (9 items, score range 0-36), depression-dejection (15 items, range 0-60), anger-hostility (12 items, range 0-48), vigor-activity (8 items, range 0-32), fatigue-inertia (7 items, range 0-28), and confusion-bewilderment (7 items, range 0-28).
High vigor-activity scores reflect a good mood or emotion, and low scores in the other subscales reflect a good mood or emotion.
Total mood disturbance, which is calculated by subtracting the vigor subscale score from the total subscale score (range 0-200), also will be assessed.
|
11-16 years post CALERIE trial
|
|
Sleep
時間枠：11-16 years post CALERIE trial
|
Sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
The PSQI measures sleep quality and disturbance over the course of one month using seven subscales: subjective sleep quality; sleep latency; sleep duration; habitual sleep efficiency; sleep disturbances; use of sleeping medication; and daytime dysfunction.
The scoring range of each subscale is 0-3.
The scoring range of the Global PSQI (the composite score of the seven subscales) is 0-21.
For both the subscales and Global PSQI, higher scores indicate greater difficulties with sleeping.
|
11-16 years post CALERIE trial
|
|
Sexual function
時間枠：11-16 years post CALERIE trial
|
Sexual function as measured by the Derogatis Interview for Sexual Functioning - Self Report (DISF-SR).
Both versions of the DISF-SR (male and female) are scored from 20 to 75, with higher scores indicating higher sexual functioning.
|
11-16 years post CALERIE trial
|
|
Food cravings
時間枠：11-16 years post CALERIE trial
|
Food cravings as measured by the Food Cravings Questionnaire-Trait (FCQ-T).
The FCQ-T measures frequency and intensity of food cravings.
It has 39 items on a 6-point Likert scale (1-6) and a score range of 39-234.
Higher scores indicate more frequent and intense food cravings.
Scores on all items are summed for a total score.
|
11-16 years post CALERIE trial
|
|
Dietary restraint, disinhibition, and hunger
時間枠：11-16 years post CALERIE trial
|
Dietary restraint, disinhibition, and hunger as measured by the Three-Factor Eating Questionnaire (TFEQ).
The 51-item TFEQ will be used to measure dietary restraint (21 items), disinhibition (16 items), and hunger (14 items).
Item responses are scored as 0 or 1 and summed.
Higher scores indicate higher levels of restrained eating (range 0-21), disinhibited eating (range 0-16), and predisposition to hunger (range 0-14).
|
11-16 years post CALERIE trial
|
|
Disordered eating
時間枠：11-16 years post CALERIE trial
|
Disordered eating as measured by the Multiaxial Assessment of Eating Disorder Symptoms (MAEDS).
MAEDS will be used to assess six domains of disordered eating: binge eating (range 8-56), restrictive eating (range 9-63), purgative behavior (range 7-49), fear of fatness (range 11-77), avoidance of forbidden foods (range 10-70), and depression (range 11-77).
|
11-16 years post CALERIE trial
|
|
Body shape perceptions
時間枠：11-16 years post CALERIE trial
|
Body shape perceptions as measured by the Body Shape Questionnaire (BSQ).
Items on the BSQ are rated on a 6-point Likert-type scale.
The score ranges from 34-204 points.
Higher scores indicate increased concern regarding body shape.
|
11-16 years post CALERIE trial
|
|
Physical activity
時間枠：11-16 years post CALERIE trial
|
Physical activity as measured by the 7-Day Stanford Physical Activity Recall (PAR).
The PAR estimates an individual's time spent in sleep and physical activity for the 7 days prior to the interview.
Energy expenditure based on time spent in sleep and physical activities can be estimated.
Sub-scores of energy expenditure for each of the following activities are calculated, summed, and averaged to estimate energy expenditure as kilocalories per day: sleep, moderate physical activity, hard physical activity, and very hard physical activity.
Higher scores indicate greater physical activity per day.
Metabolic equivalent (MET) value for each activity is provided: 1 MET for sleep, 4 METs for moderate activity, 6 METs for hard activity, and 10 METs for very hard activity.
Time spent in each activity over 7 days is multiplied by the appropriate MET value.
The minimum value for each activity is zero; there is no maximum value.
|
11-16 years post CALERIE trial
|
|
Resilience
時間枠：11-16 years post CALERIE trial
|
Resilience as measured by the 25-item Connor-Davidson Resilience Scale (CD-RISC-25).
CD-RISC-25 is scored from 0 to 100, with higher scores indicating higher resilience.
|
11-16 years post CALERIE trial
|
|
Total cholesterol
時間枠：11-16 years post CALERIE trial
|
Total cholesterol will be measured in mg/dL using a standard lipid panel.
|
11-16 years post CALERIE trial
|
|
High-density lipoprotein cholesterol (HDL-C)
時間枠：11-16 years post CALERIE trial
|
HDL-C will be measured in mg/dL using a standard lipid panel.
|
11-16 years post CALERIE trial
|
|
Triglycerides
時間枠：11-16 years post CALERIE trial
|
Triglycerides will be measured in mg/dL using a standard lipid panel.
|
11-16 years post CALERIE trial
|
|
Low-density lipoprotein cholesterol (LDL-C)
時間枠：11-16 years post CALERIE trial
|
LDL-C will be calculated in mg/dL using measured values of total cholesterol, HDL-C, and triglycerides.
|
11-16 years post CALERIE trial
|
|
Glucose - 0 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Glucose (mg/dL) will be measured at 0 minutes (pre-dose) during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Glucose - 30 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Glucose (mg/dL) will be measured at 30 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Glucose - 60 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Glucose (mg/dL) will be measured at 60 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Glucose - 90 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Glucose (mg/dL) will be measured at 90 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Glucose - 120 min (OGTT)
時間枠：11-16 years post CALERIE trial
|
Glucose (mg/dL) will be measured at 120 minutes post dose during an OGTT to evaluate glucoregulatory response.
|
11-16 years post CALERIE trial
|
|
Insulin resistance
時間枠：11-16 years post CALERIE trial
|
Insulin resistance will be calculated using the Homeostatic Model Assessment (HOMA) and measured values of fasting glucose (mmol/L) and fasting insulin (μ/L): (fasting glucose × fasting insulin) ∕ 22.5
|
11-16 years post CALERIE trial
|
|
Beta-cell function
時間枠：11-16 years post CALERIE trial
|
Beta-cell function will be calculated using HOMA-β and measures of fasting insulin (μ/L) and fasting glucose (mg/dL): HOMA-β (%) = (360 × fasting insulin) ∕ (fasting glucose - 63)
|
11-16 years post CALERIE trial
|
|
Insulinogenic Index
時間枠：11-16 years post CALERIE trial
|
Insulinogenic index will be calculated as the ratio of change in plasma insulin (I) from 0 to 30 min of the OGTT to the change in plasma glucose (G) over the same period (∆I0-30 min ∕ ∆G0-30 min).
|
11-16 years post CALERIE trial
|
|
Insulin Sensitivity Index (ISI)
時間枠：11-16 years post CALERIE trial
|
Insulin sensitivity index will be calculated as 1 ∕ fasting insulin (μ/L).
|
11-16 years post CALERIE trial
|
|
Oral Disposition Index
時間枠：11-16 years post CALERIE trial
|
The Oral Disposition Index will be calculated as the product of insulinogenic index and insulin sensitivity index.
|
11-16 years post CALERIE trial
|
|
Triiodothyronine (T3)
時間枠：11-16 years post CALERIE trial
|
T3, a blood-based marker of thyroid function, will be measured in ng/dL.
|
11-16 years post CALERIE trial
|
|
Thyroxine (T4)
時間枠：11-16 years post CALERIE trial
|
T4, a blood-based marker of thyroid function, will be measured in ng/dL.
|
11-16 years post CALERIE trial
|
|
Thyroid stimulating hormone (TSH)
時間枠：11-16 years post CALERIE trial
|
TSH, a blood-based marker of thyroid function, will be measured in μIU/mL.
|
11-16 years post CALERIE trial
|
|
Alkaline phosphatase (ALKP)
時間枠：11-16 years post CALERIE trial
|
ALKP, a blood-based marker of liver function, will be measured in IU/L.
|
11-16 years post CALERIE trial
|
|
Alanine transaminase (ALT)
時間枠：11-16 years post CALERIE trial
|
ALT, a blood-based marker of liver function, will be measured in U/L.
|
11-16 years post CALERIE trial
|
|
Aspartate aminotransferase (AST)
時間枠：11-16 years post CALERIE trial
|
AST, a blood-based marker of liver function, will be measured in U/L.
|
11-16 years post CALERIE trial
|
|
Albumin
時間枠：11-16 years post CALERIE trial
|
Albumin, a blood-based marker of liver and kidney function, will be measured in g/dL.
|
11-16 years post CALERIE trial
|
|
Blood Urea Nitrogen (BUN)
時間枠：11-16 years post CALERIE trial
|
BUN, a blood-based marker of kidney function, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
|
Total Proteins
時間枠：11-16 years post CALERIE trial
|
Total proteins are computed as a sum of albumin and globulin.
Total proteins are indicative of blood vessel and immune system function and will be measured in g/dL.
|
11-16 years post CALERIE trial
|
|
Bilirubin
時間枠：11-16 years post CALERIE trial
|
Bilirubin, a blood-based marker of liver function, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
|
Creatine Phosphokinase (CPK)
時間枠：11-16 years post CALERIE trial
|
CPK, an enzyme marker of energy homeostasis, will be measured in U/L.
|
11-16 years post CALERIE trial
|
|
Lactate Dehydrogenase (LDH)
時間枠：11-16 years post CALERIE trial
|
LDH, an enzyme marker of liver function, will be measured in U/L.
|
11-16 years post CALERIE trial
|
|
Globulin
時間枠：11-16 years post CALERIE trial
|
Globulin, a blood-based marker of liver function, will be measured in g/dL.
|
11-16 years post CALERIE trial
|
|
Albumin/Globulin (A/G) ratio
時間枠：11-16 years post CALERIE trial
|
A/G ratio is a blood-based marker used to monitor nutritional status and immune system, kidney, and liver function.
This marker is a ratio, and therefore does not have units.
|
11-16 years post CALERIE trial
|
|
Uric Acid
時間枠：11-16 years post CALERIE trial
|
Uric acid, a blood-based marker of purine metabolism, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
|
Calcium (Ca)
時間枠：11-16 years post CALERIE trial
|
Calcium, a blood-based mineral, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
|
Phosphorus (P)
時間枠：11-16 years post CALERIE trial
|
Phosphorus, a blood-based mineral, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
|
Magnesium (Mg)
時間枠：11-16 years post CALERIE trial
|
Magnesium, a blood-based mineral, will be measured in meq/L.
|
11-16 years post CALERIE trial
|
|
Sodium (Na+)
時間枠：11-16 years post CALERIE trial
|
Sodium, an electrolyte that reflects the body's fluid balance, will be measured in meq/L.
|
11-16 years post CALERIE trial
|
|
Potassium (K+)
時間枠：11-16 years post CALERIE trial
|
Potassium, an electrolyte that reflects the body's fluid balance, will be measured in meq/L.
|
11-16 years post CALERIE trial
|
|
Chloride (Cl-)
時間枠：11-16 years post CALERIE trial
|
Chloride, an electrolyte that reflects the body's fluid balance, will be measured in meq/L.
|
11-16 years post CALERIE trial
|
|
Apoprotein A1
時間枠：11-16 years post CALERIE trial
|
Apoprotein A1, a blood-based marker of lipid metabolism, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
|
Apoprotein B
時間枠：11-16 years post CALERIE trial
|
Apoprotein B, a blood-based marker of lipid metabolism, will be measured in mg/dL.
|
11-16 years post CALERIE trial
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
NAD Metabolites (NAD⁺ and NADH)
時間枠：11-16 years post CALERIE trial
|
The oxidized (NAD⁺) and reduced form (NADH) of nicotinamide adenine dinucleotide will be measured in plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and/or fluorometric enzymatic cycling assays for NAD⁺/NADH.
Concentrations will be reported as nmol per mg protein or micromolar (µM) in plasma.
|
11-16 years post CALERIE trial
|
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
協力者
捜査官
- 主任研究者：Sai Krupa Das, PhD、Tufts University
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 (実際)
2023年4月6日
一次修了 (推定)
2027年1月31日
研究の完了 (推定)
2028年1月31日
試験登録日
最初に提出
2022年9月1日
QC基準を満たした最初の提出物
2022年12月6日
最初の投稿 (実際)
2022年12月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月9日
QC基準を満たした最後の更新が送信されました
2026年6月5日
最終確認日
2026年6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?
はい
IPD プランの説明
NIH Data Public Access Policy に従って、調査の終了後、デューク大学のデータ調整センターは電子データベースをロックし、公開前にデータをクリーニングして匿名化します。 バンキング用に収集された生体試料は匿名化され、NIA AgingResearchBiobank に転送されます。NIA AgingResearchBiobank は、将来の科学研究のために研究サンプルを保管および配布するための最先端の在庫システムを利用します。
研究プロトコルとインフォームド コンセント フォームも利用可能になります。
IPD 共有時間枠
データは、一次原稿の出版時にオープンアクセス用に掲載されます。
生体試料は NIA バイオバンクに保管され、研究の完了後、すべてのサンプルが枯渇するか生存不能と見なされるまで利用可能になります。
IPD 共有アクセス基準
データの使用許可は制限されません。 ただし、関心のある研究者は、該当する Web サイトに登録してデータにアクセスする必要があります。データはダウンロードで入手できます。 この研究で収集されたデータは、縦断データおよび多変量多変量解析または適合度カイ 2 乗、ノンパラメトリック関連尺度に適応した回帰に適しています。
生体試料へのアクセスに関心のある研究者は、NIA AgingResearchBiobank の Web サイト (https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/) からリクエストを送信して、アクセスを申請する必要があります。 このリクエストを送信するには、調査チームの指定メンバーが AgingResearchBiobank Web サイトでユーザーとして登録する必要があります。 研究者は誰でも、将来の研究のために生体試料へのアクセスの要求を提出できますが、アクセスするには AgingResearchBiobank の承認が必要です。 生体試料は、承認された研究者に出荷されるサンプルとして提供されます。
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ICF
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。