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CALERIE™ arvestudiet

5. juni 2026 opdateret af: Sai Krupa Das, Tufts University

Ældre virkninger af CALERIE™, en 2-årig kaloriebegrænsningsintervention, på kendetegn for sundhed og aldring

Formålet med CALERIE Legacy Study er at følge op på deltagernes sundhed og velvære fra fase 2 af undersøgelsen Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE), som blev gennemført fra 2007 til 2011.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Detaljeret beskrivelse

CALERIE Legacy Study er en observationel opfølgningsundersøgelse af deltagere fra fase 2 CALERIE forsøget, det første randomiserede kontrollerede forsøg med kaloriebegrænsning (CR) hos mennesker uden fedme. Det overordnede mål med CALERIE Legacy Study er at undersøge, om to års CR resulterer i vedvarende forbedringer i de biologiske, fænotypiske og funktionelle kendetegn ved menneskelig aldring 10 til 15 år efter den strukturerede intervention. Deltagerne vil gennemføre kliniske vurderinger, kosttilbagekaldelser og spørgeskemaer, og laboratorieevalueringer vil blive udført på blod- og urinprøver. Undersøgelsen omfatter også en valgfri biospecimen banking-komponent.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Observationel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
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Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

33 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Alle CALERIE-deltagere, undtagen dem, der er døde, vides ikke at kvalificere sig eller ikke startede deres tildelte gruppe (CR-intervention eller ad libitum-kontrol) (n = 4), er blevet identificeret som potentielle forsøgspersoner (n = 216) i CALERIE Legacy Study. Den demografiske profil af denne undersøgelse forventes at svare til den for CALERIE-forsøget, som var 70,4 % kvinder. Raske personer uden fedme af begge køn og alle racer og etniske grupper var berettiget til at deltage i CALERIE-forsøget. På grund af sikkerhedshensyn blev gravide kvinder dog udelukket, og for at undgå konfundering fra peri- og postmenopausal status var den øvre aldersgrænse for kvinder 47 år. Ved tilmelding var CALERIE-deltagerne 20-50 år, 77,3 % hvide, 12 % sorte og 10,7 % andre; etnicitet var 97% ikke-spansktalende.

Beskrivelse

Inklusionskriterier:

  • Tilmeldt CALERIE-forsøget og startede deres tildelte gruppe (CR-intervention eller ad libitum kontroltilstand)
  • Villig og i stand til at deltage i et af de kliniske steder for et personligt besøg og give informeret samtykke

Ekskluderingskriterier:

  • Gravid kvinde
  • Kvinder mindre end 12 måneder efter fødslen
  • Dokumenteret notat fra CALERIE-forsøget, der indikerer, at forsøgspersonen ikke skal kontaktes eller anmodes om ikke at blive kontaktet til fremtidig forskning
  • Diagnosticeret aktiv cancer eller terminal sygdom

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Andet

Kohorter og interventioner

Gruppe / kohorte

Gruppe / kohorte

En gruppe eller undergruppe af deltagere i et observationsstudie, der vurderes for biomedicinske eller sundhedsmæssige resultater.
Kaloriebegrænsning (CR)
Personer i CR-gruppen fik ordineret en reduktion på 25 % i forhold til deres baseline-energiindtag under det to-årige CALERIE-forsøg.
Ad Libitum (AL)
Individer i AL-gruppen blev bedt om at fortsætte deres sædvanlige diætindtag under det to-årige CALERIE-forsøg.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
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

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
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

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Tufts University

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Washington University School of Medicine
Duke University
National Institute on Aging (NIA)
Pennington Biomedical Research Center

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Ledende efterforsker: Sai Krupa Das, PhD, Tufts University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
6. april 2023

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
31. januar 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
31. januar 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
1. september 2022

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
6. december 2022

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
15. december 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
5. juni 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • STUDY00002577
  • 1R01AG071717-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

I henhold til NIH's politik for offentlig adgang til data vil datakoordineringscentret på Duke University efter afslutning af undersøgelsen låse den elektroniske database og rense og afidentificere dataene før offentlig udstationering. Bioprøver indsamlet til bankvirksomhed vil blive afidentificeret og overført til NIA AgingResearchBiobank, som bruger et avanceret opgørelsessystem til opbevaring og distribution af undersøgelsesprøver til fremtidig videnskabelig forskning.

Undersøgelsesprotokollen og informeret samtykkeformular vil også blive gjort tilgængelige.

IPD-delingstidsramme

Data vil blive opslået til åben adgang på tidspunktet for offentliggørelsen af ​​det primære manuskript. Bioprøver vil blive opbevaret i NIA Biobank og vil være tilgængelige efter afslutning af undersøgelsen, og indtil alle prøver er opbrugt eller vurderes ikke levedygtige.

IPD-delingsadgangskriterier

Tilladelsen til at bruge data vil ikke være begrænset. Interesserede efterforskere skal dog registrere sig på det relevante websted for at få adgang til data, som vil blive gjort tilgængelige via download. Data indsamlet i denne undersøgelse vil være passende til regression tilpasset longitudinelle data og multivariat-multivariabel analyse eller goodness-of-fit chi-square, ikke-parametriske mål for association.

Efterforskere, der er interesseret i at få adgang til bioprøver, skal ansøge om adgang ved at indsende en anmodning via NIA AgingResearchBiobank-webstedet (https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/). For at indsende denne anmodning skal et udpeget medlem af efterforskningsteamet registrere sig som bruger på AgingResearchBiobank-webstedet. Enhver investigator kan indsende en anmodning om adgang til bioprøverne til fremtidig forskning, men skal godkendes af AgingResearchBiobank for at få adgang. Bioprøver vil blive leveret som prøver, der vil blive sendt til godkendte efterforskere.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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