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CALERIE™ arvestudien

5. juni 2026 oppdatert av: Sai Krupa Das, Tufts University

Legacy Effects of CALERIE™, en 2-årig kalorirestriksjonsintervensjon, på kjennetegn på helse og aldring

Formålet med CALERIE Legacy Study er å følge opp helse og velvære til deltakere fra fase 2 av studien Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE), som ble gjennomført fra 2007 til 2011.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Detaljert beskrivelse

CALERIE Legacy Study er en observasjonsoppfølgingsstudie av deltakere fra fase 2 CALERIE-studien, den første randomiserte kontrollerte studien av kalorirestriksjon (CR) hos mennesker uten fedme. Det overordnede målet med CALERIE Legacy Study er å undersøke om to år med CR resulterer i vedvarende forbedringer i de biologiske, fenotypiske og funksjonelle kjennetegnene ved menneskelig aldring 10 til 15 år etter den strukturerte intervensjonen. Deltakerne vil fullføre kliniske vurderinger, tilbakekalling av kosthold og spørreskjemaer, og laboratorieevalueringer vil bli utført på blod- og urinprøver. Studien inkluderer også en valgfri bioprøvebankkomponent.

Studietype

Observasjonsmessig

Registrering (Antatt)

216

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

33 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Alle CALERIE-deltakere, bortsett fra de som er døde, er kjent for ikke å kvalifisere seg, eller ikke startet sin tildelte gruppe (CR-intervensjon eller ad libitum-kontroll) (n = 4), har blitt identifisert som potensielle forsøkspersoner (n = 216) i CALERIE Legacy Study. Den demografiske profilen til denne studien forventes å være lik den for CALERIE-studien, som var 70,4 % kvinner. Friske individer uten fedme av begge kjønn og alle rase og etniske grupper var kvalifisert til å delta i CALERIE-studien. På grunn av sikkerhetshensyn ble gravide kvinner ekskludert, og for å unngå konfundering fra peri- og postmenopausal status, var den øvre aldersgrensen for kvinner 47 år. Ved påmelding var CALERIE-deltakerne 20-50 år, 77,3 % hvite, 12 % svarte og 10,7 % andre; etnisitet var 97 % ikke-spansktalende.

Beskrivelse

Inklusjonskriterier:

  • Registrert i CALERIE-studien og startet sin tildelte gruppe (CR-intervensjon eller ad libitum-kontrolltilstand)
  • Villig og i stand til å delta på et av de kliniske stedene for et personlig besøk og gi informert samtykke

Ekskluderingskriterier:

  • Gravide kvinner
  • Kvinner mindre enn 12 måneder etter fødselen
  • Dokumentert notat fra CALERIE-forsøket som indikerer at forsøkspersonen ikke bør kontaktes eller bes om ikke å bli kontaktet for fremtidig forskning
  • Diagnostisert aktiv kreft eller terminal sykdom

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Case-Control
  • Tidsperspektiver: Annen

Kohorter og intervensjoner

Gruppe / Kohort
Kalorirestriksjon (CR)
Individer i CR-gruppen ble foreskrevet en 25 % reduksjon fra deres baseline energiinntak i løpet av den toårige CALERIE-studien.
Ad Libitum (AL)
Individer i AL-gruppen ble bedt om å fortsette sitt vanlige diettinntak under den toårige CALERIE-studien.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Biological age - Klemera-Doubal Method
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
NAD Metabolites (NAD⁺ and NADH)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Tufts University

Samarbeidspartnere

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

Etterforskere

  • Hovedetterforsker: Sai Krupa Das, PhD, Tufts University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. april 2023

Primær fullføring (Antatt)

31. januar 2027

Studiet fullført (Antatt)

31. januar 2028

Datoer for studieregistrering

Først innsendt

1. september 2022

Først innsendt som oppfylte QC-kriteriene

6. desember 2022

Først lagt ut (Faktiske)

15. desember 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • STUDY00002577
  • 1R01AG071717-01A1 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

I henhold til NIHs retningslinjer for offentlig tilgang til data, vil datakoordineringssenteret ved Duke University etter avsluttet studie låse den elektroniske databasen og rense og avidentifisere dataene før offentlig publisering. Bioprøver som samles inn for banktjenester vil bli avidentifisert og overført til NIA AgingResearchBiobank, som bruker et toppmoderne inventarsystem for lagring og distribusjon av studieprøver for fremtidig vitenskapelig forskning.

Studieprotokollen og skjemaet for informert samtykke vil også bli gjort tilgjengelig.

IPD-delingstidsramme

Data vil bli lagt ut for bruk med åpen tilgang på tidspunktet for publisering av primærmanuskriptet. Bioprøver vil bli lagret i NIA Biobank og vil være tilgjengelige når studien er fullført og inntil alle prøver er uttømt eller ansett som ikke levedyktige.

Tilgangskriterier for IPD-deling

Tillatelse til å bruke data vil ikke være begrenset. Imidlertid må interesserte etterforskere registrere seg på det aktuelle nettstedet for å få tilgang til data, som vil bli gjort tilgjengelig via nedlasting. Data samlet inn i denne studien vil være passende for regresjon tilpasset longitudinelle data og multivariat-multivariabel analyse eller goodness-of-fit chi-kvadrat, ikke-parametriske mål for assosiasjon.

Etterforskere som er interessert i å få tilgang til bioprøver, må søke om tilgang ved å sende inn en forespørsel via nettstedet til NIA AgingResearchBiobank (https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/). For å sende inn denne forespørselen, må et utpekt medlem av etterforskningsteamet registrere seg som bruker på nettstedet AgingResearchBiobank. Enhver etterforsker kan sende inn en forespørsel om tilgang til bioprøvene for fremtidig forskning, men må godkjennes av AgingResearchBiobank for å få tilgang. Bioprøver vil bli levert som prøver som vil bli sendt til godkjente etterforskere.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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