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O Estudo do Legado CALERIE™

5 de junho de 2026 atualizado por: Sai Krupa Das, Tufts University

Efeitos herdados de CALERIE™, uma intervenção de restrição calórica de 2 anos, em marcas de saúde e envelhecimento

O objetivo do CALERIE Legacy Study é acompanhar a saúde e o bem-estar dos participantes da fase 2 do estudo Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE), realizado de 2007 a 2011.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Descrição detalhada

O CALERIE Legacy Study é um estudo observacional de acompanhamento de participantes da fase 2 do estudo CALERIE, o primeiro estudo controlado randomizado de restrição calórica (CR) em humanos sem obesidade. O objetivo geral do CALERIE Legacy Study é examinar se dois anos de RC resultam em melhorias sustentadas nas características biológicas, fenotípicas e funcionais do envelhecimento humano 10 a 15 anos após a intervenção estruturada. Os participantes completarão avaliações clínicas, recordatórios alimentares e questionários, e avaliações laboratoriais serão realizadas em amostras de sangue e urina. O estudo também inclui um componente opcional de banco de bioespécimes.

Tipo de estudo

Observacional

Inscrição (Estimado)

216

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

33 anos a 70 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

Todos os participantes do CALERIE, exceto aqueles que faleceram, não se qualificaram ou não iniciaram seu grupo alocado (intervenção CR ou controle ad libitum) (n = 4), foram identificados como sujeitos potenciais (n = 216) no Estudo do Legado CALERIE. Espera-se que o perfil demográfico deste estudo seja semelhante ao do estudo CALERIE, que foi 70,4% feminino. Indivíduos saudáveis ​​sem obesidade de ambos os sexos e de todas as raças e grupos étnicos foram elegíveis para participar do estudo CALERIE. No entanto, devido a questões de segurança, as mulheres grávidas foram excluídas e, para evitar confundir o estado peri e pós-menopausa, o limite superior de idade para as mulheres era de 47 anos. No momento da inscrição, os participantes do CALERIE tinham entre 20 e 50 anos, 77,3% de brancos, 12% de negros e 10,7% de outros; a etnia era 97% não-hispânica.

Descrição

Critério de inclusão:

  • Inscreveu-se no estudo CALERIE e iniciou seu grupo alocado (intervenção CR ou condição de controle ad libitum)
  • Disposto e capaz de comparecer a um dos locais clínicos para uma visita pessoal e fornecer consentimento informado

Critério de exclusão:

  • mulheres grávidas
  • Mulheres com menos de 12 meses pós-parto
  • Nota documentada do estudo CALERIE indicando que o sujeito não deve ser contatado ou solicitado a não ser contatado para pesquisas futuras
  • Câncer ativo diagnosticado ou doença terminal

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: Controle de caso
  • Perspectivas de Tempo: Outro

Coortes e Intervenções

Grupo / Coorte
Restrição de calorias (CR)
Indivíduos no grupo CR receberam uma redução de 25% de sua ingestão energética basal durante o teste CALERIE de dois anos.
Ad libitum (AL)
Indivíduos no grupo AL foram solicitados a continuar sua ingestão alimentar habitual durante o estudo CALERIE de dois anos.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Biological age - Klemera-Doubal Method
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Biological age - Homeostatic Dysregulation
Prazo: 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
Prazo: 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
Prazo: 11-16 years post CALERIE trial
Height will be measured in cm.
11-16 years post CALERIE trial
Weight
Prazo: 11-16 years post CALERIE trial
Weight will be measured in kg.
11-16 years post CALERIE trial
Waist circumference
Prazo: 11-16 years post CALERIE trial
Weight circumference will be measured in cm.
11-16 years post CALERIE trial
Hip circumference
Prazo: 11-16 years post CALERIE trial
Hip circumference will be measured in cm.
11-16 years post CALERIE trial
Body mass index (BMI)
Prazo: 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
Prazo: 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
Prazo: 11-16 years post CALERIE trial
Pulse rate will be measured in beats/min.
11-16 years post CALERIE trial
Respiration rate at rest
Prazo: 11-16 years post CALERIE trial
Respiration rate will be measured in breaths/min.
11-16 years post CALERIE trial
Fat mass
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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°)
Prazo: 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°)
Prazo: 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°)
Prazo: 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°)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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+)
Prazo: 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+)
Prazo: 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-)
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
NAD Metabolites (NAD⁺ and NADH)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tufts University

Colaboradores

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

Investigadores

  • Investigador principal: Sai Krupa Das, PhD, Tufts University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de abril de 2023

Conclusão Primária (Estimado)

31 de janeiro de 2027

Conclusão do estudo (Estimado)

31 de janeiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de setembro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de dezembro de 2022

Primeira postagem (Real)

15 de dezembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • STUDY00002577
  • 1R01AG071717-01A1 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De acordo com a Política de Acesso Público a Dados do NIH, após o encerramento do estudo, o centro de coordenação de dados da Duke University bloqueará o banco de dados eletrônico e limpará e desidentificará os dados antes da publicação pública. Os bioespécimes coletados para armazenamento bancário serão desidentificados e transferidos para o NIA AgingResearchBiobank, que utiliza um sistema de inventário de última geração para armazenamento e distribuição de amostras de estudo para pesquisas científicas futuras.

O protocolo do estudo e o formulário de consentimento informado também serão disponibilizados.

Prazo de Compartilhamento de IPD

Os dados serão publicados para uso de acesso aberto no momento da publicação do manuscrito primário. As amostras biológicas serão armazenadas no NIA Biobank e estarão disponíveis após a conclusão do estudo e até que todas as amostras sejam esgotadas ou consideradas inviáveis.

Critérios de acesso de compartilhamento IPD

A permissão para usar os dados não será restrita. No entanto, os investigadores interessados ​​devem se registrar no site aplicável para acessar os dados, que serão disponibilizados via download. Os dados coletados neste estudo serão apropriados para regressão adaptada a dados longitudinais e análise multivariada-multivariada ou qui-quadrado de qualidade de ajuste, medidas não paramétricas de associação.

Os investigadores interessados ​​em acessar bioespécimes precisarão solicitar acesso enviando uma solicitação por meio do site NIA AgingResearchBiobank (https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/). Para enviar essa solicitação, um membro designado da equipe de investigação deverá se registrar como usuário no site do AgingResearchBiobank. Qualquer investigador pode enviar uma solicitação de acesso aos bioespécimes para pesquisas futuras, mas deve ser aprovado pelo AgingResearchBiobank para obter acesso. Os bioespécimes serão fornecidos como amostras que serão enviadas para investigadores aprovados.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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