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CALERIE™ 레거시 연구

2026년 6월 5일 업데이트: Sai Krupa Das, Tufts University

건강 수명 및 노화의 특징에 대한 2년 칼로리 제한 개입인 CALERIE™의 레거시 효과

CALERIE 레거시 연구의 목적은 2007년부터 2011년까지 수행된 CALERIE(에너지 섭취 감소의 장기적 효과 종합 평가) 시험의 2단계에서 참가자의 건강과 웰빙을 추적하는 것입니다.

연구 개요

상태

모집하지 않고 적극적으로

정황

상세 설명

CALERIE 레거시 연구는 비만이 없는 인간의 칼로리 제한(CR)에 대한 최초의 무작위 대조 시험인 CALERIE 시험의 2상 참가자에 대한 관찰 후속 연구입니다. CALERIE 레거시 연구의 가장 중요한 목표는 2년간의 CR이 구조화된 개입 후 10~15년 동안 인간 노화의 생물학적, 표현형 및 기능적 특징을 지속적으로 개선하는지 여부를 조사하는 것입니다. 참가자는 임상 평가, 식이 회수 및 설문지를 완료하고 혈액 및 소변 샘플에 대해 실험실 평가를 수행합니다. 이 연구에는 선택적 생물 표본 은행 구성 요소도 포함됩니다.

연구 유형

관찰

등록 (추정된)

216

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Louisiana
      • Baton Rouge, Louisiana, 미국, 70808
        • Pennington Biomedical Research Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02111
        • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
    • Missouri
      • St Louis, Missouri, 미국, 63110-1010
        • Washington University School of Medicine

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

33년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

사망한 사람을 제외한 모든 CALERIE 참가자는 자격이 없거나 할당된 그룹(CR 개입 또는 자유 통제)을 시작하지 않은 것으로 알려져 있습니다(n = 4). CALERIE 레거시 연구. 이 연구의 인구통계학적 프로필은 70.4%가 여성이었던 CALERIE 시험과 유사할 것으로 예상됩니다. 성별, 모든 인종 및 민족 그룹의 비만이 없는 건강한 개인은 CALERIE 시험에 참여할 자격이 있습니다. 그러나 안전 문제로 인해 임산부는 제외되었으며, 폐경 전후 상태에 대한 혼란을 피하기 위해 여성의 상한 연령 제한은 47세였습니다. 등록 당시 CALERIE 참가자는 20-50세였으며 백인이 77.3%, 흑인이 12%, 기타가 10.7%였습니다. 인종은 97%가 비 히스패닉이었습니다.

설명

포함 기준:

  • CALERIE 시험에 등록하고 할당된 그룹을 시작했습니다(CR 개입 또는 임의 제어 조건).
  • 직접 방문을 위해 임상 현장 중 하나에 참석하고 정보에 입각한 동의를 제공할 의향과 능력

제외 기준:

  • 임산부
  • 산후 12개월 미만의 여성
  • CALERIE 시험에서 피험자에게 연락하지 말거나 향후 연구를 위해 연락하지 말라고 요청해야 한다는 문서화된 메모
  • 활동성 암 또는 불치병 진단

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 케이스 컨트롤
  • 시간 관점: 다른

코호트 및 개입

그룹/코호트
칼로리 제한(CR)
CR 그룹의 개인은 2년 간의 CALERIE 시험 기간 동안 기본 에너지 섭취량에서 25% 감소하도록 처방되었습니다.
광고 리비텀(AL)
AL 그룹의 개인은 2년 간의 CALERIE 시험 기간 동안 평소 식이 섭취를 계속하도록 요청받았습니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Biological age - Klemera-Doubal Method
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Biological age - Homeostatic Dysregulation
기간: 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
기간: 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
기간: 11-16 years post CALERIE trial
Height will be measured in cm.
11-16 years post CALERIE trial
Weight
기간: 11-16 years post CALERIE trial
Weight will be measured in kg.
11-16 years post CALERIE trial
Waist circumference
기간: 11-16 years post CALERIE trial
Weight circumference will be measured in cm.
11-16 years post CALERIE trial
Hip circumference
기간: 11-16 years post CALERIE trial
Hip circumference will be measured in cm.
11-16 years post CALERIE trial
Body mass index (BMI)
기간: 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
기간: 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
기간: 11-16 years post CALERIE trial
Pulse rate will be measured in beats/min.
11-16 years post CALERIE trial
Respiration rate at rest
기간: 11-16 years post CALERIE trial
Respiration rate will be measured in breaths/min.
11-16 years post CALERIE trial
Fat mass
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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°)
기간: 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°)
기간: 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°)
기간: 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°)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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+)
기간: 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+)
기간: 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-)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
NAD Metabolites (NAD⁺ and NADH)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tufts University

협력자

Washington University School of Medicine
Duke University
National Institute on Aging (NIA)
Pennington Biomedical Research Center

수사관

  • 수석 연구원: Sai Krupa Das, PhD, Tufts University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 4월 6일

기본 완료 (추정된)

2027년 1월 31일

연구 완료 (추정된)

2028년 1월 31일

연구 등록 날짜

최초 제출

2022년 9월 1일

QC 기준을 충족하는 최초 제출

2022년 12월 6일

처음 게시됨 (실제)

2022년 12월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 5일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • STUDY00002577
  • 1R01AG071717-01A1 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

NIH 데이터 공개 액세스 정책에 따라 연구 종료 후 Duke University의 데이터 조정 센터는 전자 데이터베이스를 잠그고 공개 게시 전에 데이터를 정리하고 비식별화합니다. 은행 업무를 위해 수집된 생물 표본은 비식별화되어 NIA AgingResearchBiobank로 전송되며, NIA AgingResearchBiobank는 미래 과학 연구를 위한 연구 샘플의 보관 및 배포를 위해 최첨단 재고 시스템을 활용합니다.

연구 프로토콜 및 정보에 입각한 동의서 양식도 제공됩니다.

IPD 공유 기간

데이터는 기본 원고가 출판될 때 오픈 액세스 사용을 위해 게시됩니다. 생물 표본은 NIA Biobank에 보관되며 연구가 완료되면 모든 샘플이 고갈되거나 생존할 수 없는 것으로 간주될 때까지 사용할 수 있습니다.

IPD 공유 액세스 기준

데이터 사용 권한은 제한되지 않습니다. 그러나 관심 있는 조사자는 다운로드를 통해 제공되는 데이터에 액세스하려면 해당 웹사이트에 등록해야 합니다. 이 연구에서 수집된 데이터는 종단 데이터 및 다변량-다변량 분석 또는 적합도 카이-제곱, 비모수적 연관성 측정에 적합한 회귀에 적합합니다.

생물 표본 접근에 관심이 있는 조사자는 NIA AgingResearchBiobank 웹사이트(https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/)를 통해 요청을 제출하여 접근 권한을 신청해야 합니다. 이 요청을 제출하려면 조사팀의 지정된 구성원이 AgingResearchBiobank 웹사이트에 사용자로 등록해야 합니다. 모든 조사자는 향후 연구를 위해 생물 표본에 대한 액세스 요청을 제출할 수 있지만 액세스 권한을 얻으려면 AgingResearchBiobank의 승인을 받아야 합니다. 생체 표본은 승인된 조사자에게 배송될 샘플로 제공됩니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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