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Clinical Trials/NCT05651620
NCT05651620Active, not recruitingNot Applicable

Legacy Effects of CALERIE™, a 2-year Calorie Restriction Intervention, on Hallmarks of Healthspan and Aging

Tufts University3 sites in 1 country216 target enrollmentStarted: April 6, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
216
Locations
3
Primary Endpoint
Biological age - Klemera-Doubal Method
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of the CALERIE Legacy Study is to follow up on the health and wellness of participants from phase 2 of the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) trial, which was conducted from 2007 to 2011.

Detailed Description

The CALERIE Legacy Study is an observational follow-up study of participants from phase 2 the CALERIE trial, the first randomized controlled trial of calorie restriction (CR) in humans without obesity. The overarching goal of the CALERIE Legacy Study is to examine whether two years of CR results in sustained improvements in the biological, phenotypic, and functional hallmarks of human aging 10 to 15 years after the structured intervention. Participants will complete clinical assessments, dietary recalls, and questionnaires, and laboratory evaluations will be performed on blood and urine samples. The study also includes an optional biospecimen banking component.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Other

Eligibility Criteria

Ages
33 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Enrolled in the CALERIE trial and started their allocated group (CR intervention or ad libitum control condition)
  • •Willing and able to attend one of the clinical sites for an in-person visit and provide informed consent

Exclusion Criteria

  • •Pregnant women
  • •Women less than 12 months postpartum
  • •Documented note from the CALERIE trial indicating that the subject should not be contacted or requested not to be contacted for future research
  • •Diagnosed active cancer or terminal illness

Arms & Interventions

Calorie Restriction (CR)

Individuals in the CR group were prescribed a 25% reduction from their baseline energy intake during the two-year CALERIE trial.

Ad Libitum (AL)

Individuals in the AL group were asked to continue their usual dietary intake during the two-year CALERIE trial.

Outcomes

Primary Outcomes

Biological age - Klemera-Doubal Method

Time Frame: 10-15 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.

Healthspan

Time Frame: 10-15 years post CALERIE trial

Healthspan will be assessed by sex-specific metabolic syndrome score (MSS). MSS was developed using mean blood pressure (MBP; = \[2 × diastolic blood pressure + systolic blood pressure\]/3), high density lipoprotein cholesterol (HDL), triglycerides (TG), waist circumference (WC), and fasting blood glucose (FBG): Women: MSS = \[45-HDL\]/SDHDLW+ \[TG-150\]/SDTG + \[WC-88\]/SDWCW + \[FBG-100\]/SDFBG + \[mean BP-100\]/SDMBP Men: MSS = \[40-HDL\]/SDHDLW+ \[TG-150\]/SDTG + \[WC-102\]/SDWCW + \[FBG-100\]/SDFBG + \[mean BP-100\]/SDMBP This score does not have a unit.

Biological age - Klemera-Doubal Method

Time Frame: 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.

Healthspan

Time Frame: 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.

Secondary Outcomes

  • Leptin(10-15 years post CALERIE trial)
  • Alkaline phosphatase (ALKP)(10-15 years post CALERIE trial)
  • Alanine transaminase (ALT)(10-15 years post CALERIE trial)
  • Aspartate aminotransferase (AST)(10-15 years post CALERIE trial)
  • Albumin(10-15 years post CALERIE trial)
  • Blood Urea Nitrogen (BUN)(10-15 years post CALERIE trial)
  • Insulin - 30 min (OGTT)(10-15 years post CALERIE trial)
  • Height(10-15 years post CALERIE trial)
  • Weight(10-15 years post CALERIE trial)
  • Waist circumference(10-15 years post CALERIE trial)
  • Hip circumference(10-15 years post CALERIE trial)
  • Body mass index (BMI)(10-15 years post CALERIE trial)
  • Blood pressure(10-15 years post CALERIE trial)
  • Pulse rate at rest(10-15 years post CALERIE trial)
  • Respiration rate at rest(10-15 years post CALERIE trial)
  • Fat-free mass(10-15 years post CALERIE trial)
  • Fat mass(10-15 years post CALERIE trial)
  • Bone mineral content(10-15 years post CALERIE trial)
  • Resting metabolic rate (RMR)(10-15 years post CALERIE trial)
  • Respiratory quotient (RQ)(10-15 years post CALERIE trial)
  • Maximal aerobic capacity (V̇O2max)(10-15 years post CALERIE trial)
  • Interleukin-6 (IL-6)(10-15 years post CALERIE trial)
  • Insulin - TAME panel(10-15 years post CALERIE trial)
  • Insulin - 0 min (OGTT)(10-15 years post CALERIE trial)
  • Monocyte Chemoattractant Protein 1 (MCP1)(10-15 years post CALERIE trial)
  • Insulin - 60 min (OGTT)(10-15 years post CALERIE trial)
  • Insulin - 90 min (OGTT)(10-15 years post CALERIE trial)
  • Insulin - 120 min (OGTT)(10-15 years post CALERIE trial)
  • Insulin-like growth factor 1 (IGF-1)(10-15 years post CALERIE trial)
  • Hemoglobin A1c (HbA1c)(10-15 years post CALERIE trial)
  • Tumor necrosis factor α receptor II (TNFRII)(10-15 years post CALERIE trial)
  • High-sensitivity C-reactive protein (hsCRP)(10-15 years post CALERIE trial)
  • Growth/differentiation factor 15 (GDF15)(10-15 years post CALERIE trial)
  • Cystatin C(10-15 years post CALERIE trial)
  • N-terminal B-type natriuretic peptide (NT-proBNP)(10-15 years post CALERIE trial)
  • Senescence-associated secretory phenotype (SASP) proteins(10-15 years post CALERIE trial)
  • Urinary Isoprostanes - iPF(2α)-III(10-15 years post CALERIE trial)
  • Urinary Isoprostanes - 2,3-dinor-iPF(2α)-III(10-15 years post CALERIE trial)
  • Urinary Isoprostanes - iPF(2α)-VI(10-15 years post CALERIE trial)
  • Urinary Isoprostanes - 8,12-iso-iPF(2α)-VI(10-15 years post CALERIE trial)
  • Creatinine(10-15 years post CALERIE trial)
  • Dehydroepiandrosterone (DHEA)(10-15 years post CALERIE trial)
  • Interleukin 1 beta (IL-1b)(10-15 years post CALERIE trial)
  • Interleukin 8 (IL-8)(10-15 years post CALERIE trial)
  • Tumor necrosis factor α (TNF-α)(10-15 years post CALERIE trial)
  • Insulin-like growth factor-binding protein 1 (IGFBP-1)(10-15 years post CALERIE trial)
  • Transforming growth factor beta 1 (TGFB1)(10-15 years post CALERIE trial)
  • Insulin-like growth factor-binding protein 3 (IGFBP-3)(10-15 years post CALERIE trial)
  • Platelet-derived growth factor-AB (PDGF-AB)(10-15 years post CALERIE trial)
  • Intercellular Adhesion Molecule 1 (ICAM-1)(10-15 years post CALERIE trial)
  • Growth hormone(10-15 years post CALERIE trial)
  • Total adiponectin(10-15 years post CALERIE trial)
  • High molecular weight adiponectin(10-15 years post CALERIE trial)
  • Muscle strength - Knee extension (60°)(10-15 years post CALERIE trial)
  • Muscle strength - Knee extension (180°)(10-15 years post CALERIE trial)
  • Muscle strength - Knee flexion (60°)(10-15 years post CALERIE trial)
  • Muscle strength - Knee flexion (180°)(10-15 years post CALERIE trial)
  • Handgrip Strength(10-15 years post CALERIE trial)
  • Physical functioning(10-15 years post CALERIE trial)
  • Cognition(10-15 years post CALERIE trial)
  • Dietary intake- calories(10-15 years post CALERIE trial)
  • Dietary intake - carbohydrates(10-15 years post CALERIE trial)
  • Dietary intake - proteins(10-15 years post CALERIE trial)
  • Triglycerides(10-15 years post CALERIE trial)
  • Low-density lipoprotein cholesterol (LDL-C)(10-15 years post CALERIE trial)
  • Health-related quality of life(10-15 years post CALERIE trial)
  • Depression status(10-15 years post CALERIE trial)
  • Mood(10-15 years post CALERIE trial)
  • Sleep(10-15 years post CALERIE trial)
  • Sexual function(10-15 years post CALERIE trial)
  • Food cravings(10-15 years post CALERIE trial)
  • Dietary restraint, disinhibition, and hunger(10-15 years post CALERIE trial)
  • Disordered eating(10-15 years post CALERIE trial)
  • Body shape perceptions(10-15 years post CALERIE trial)
  • Physical activity(10-15 years post CALERIE trial)
  • Resilience(10-15 years post CALERIE trial)
  • Total cholesterol(10-15 years post CALERIE trial)
  • High-density lipoprotein cholesterol (HDL-C)(10-15 years post CALERIE trial)
  • Glucose - 0 min (OGTT)(10-15 years post CALERIE trial)
  • Glucose - 30 min (OGTT)(10-15 years post CALERIE trial)
  • Glucose - 60 min (OGTT)(10-15 years post CALERIE trial)
  • Glucose - 90 min (OGTT)(10-15 years post CALERIE trial)
  • Glucose - 120 min (OGTT)(10-15 years post CALERIE trial)
  • Insulin resistance(10-15 years post CALERIE trial)
  • Beta-cell function(10-15 years post CALERIE trial)
  • Triiodothyronine (T3)(10-15 years post CALERIE trial)
  • Thyroxine (T4)(10-15 years post CALERIE trial)
  • Thyroid stimulating hormone (TSH)(10-15 years post CALERIE trial)
  • Total Proteins(10-15 years post CALERIE trial)
  • Bilirubin(10-15 years post CALERIE trial)
  • Creatine Phosphokinase (CPK)(10-15 years post CALERIE trial)
  • Lactate Dehydrogenase (LDH)(10-15 years post CALERIE trial)
  • Globulin(10-15 years post CALERIE trial)
  • Albumin/Globulin (A/G) ratio(10-15 years post CALERIE trial)
  • Uric Acid(10-15 years post CALERIE trial)
  • Calcium (Ca)(10-15 years post CALERIE trial)
  • Phosphorus (P)(10-15 years post CALERIE trial)
  • Magnesium (Mg)(10-15 years post CALERIE trial)
  • Sodium (Na+)(10-15 years post CALERIE trial)
  • Potassium (K+)(10-15 years post CALERIE trial)
  • Chloride (Cl-)(10-15 years post CALERIE trial)
  • Apoprotein A1(10-15 years post CALERIE trial)
  • Apoprotein B(10-15 years post CALERIE trial)
  • Weight(11-16 years post CALERIE trial)
  • Waist circumference(11-16 years post CALERIE trial)
  • Biological age - Homeostatic Dysregulation(11-16 years post CALERIE trial)
  • Biological age - Levine Phenotypic Age(11-16 years post CALERIE trial)
  • Height(11-16 years post CALERIE trial)
  • Hip circumference(11-16 years post CALERIE trial)
  • Body mass index (BMI)(11-16 years post CALERIE trial)
  • Blood pressure(11-16 years post CALERIE trial)
  • Pulse rate at rest(11-16 years post CALERIE trial)
  • Respiration rate at rest(11-16 years post CALERIE trial)
  • Fat mass(11-16 years post CALERIE trial)
  • Fat-free mass(11-16 years post CALERIE trial)
  • Bone mineral content(11-16 years post CALERIE trial)
  • Resting metabolic rate (RMR)(11-16 years post CALERIE trial)
  • Respiratory quotient (RQ)(11-16 years post CALERIE trial)
  • Maximal aerobic capacity (V̇O2max)(11-16 years post CALERIE trial)
  • Interleukin-6 (IL-6)(11-16 years post CALERIE trial)
  • Insulin - TAME panel(11-16 years post CALERIE trial)
  • Insulin - 0 min (OGTT)(11-16 years post CALERIE trial)
  • Insulin - 30 min (OGTT)(11-16 years post CALERIE trial)
  • Insulin - 60 min (OGTT)(11-16 years post CALERIE trial)
  • Insulin - 90 min (OGTT)(11-16 years post CALERIE trial)
  • Insulin - 120 min (OGTT)(11-16 years post CALERIE trial)
  • Insulin-like growth factor 1 (IGF-1)(11-16 years post CALERIE trial)
  • Hemoglobin A1c (HbA1c)(11-16 years post CALERIE trial)
  • Tumor necrosis factor α receptor II (TNFRII)(11-16 years post CALERIE trial)
  • High-sensitivity C-reactive protein (hsCRP)(11-16 years post CALERIE trial)
  • Growth/differentiation factor 15 (GDF15)(11-16 years post CALERIE trial)
  • Cystatin C(11-16 years post CALERIE trial)
  • N-terminal B-type natriuretic peptide (NT-proBNP)(11-16 years post CALERIE trial)
  • Senescence-associated secretory phenotype (SASP) proteins(11-16 years post CALERIE trial)
  • Urinary Isoprostanes - iPF(2α)-III(11-16 years post CALERIE trial)
  • Urinary Isoprostanes - 2,3-dinor-iPF(2α)-III(11-16 years post CALERIE trial)
  • Urinary Isoprostanes - iPF(2α)-VI(11-16 years post CALERIE trial)
  • Urinary Isoprostanes - 8,12-iso-iPF(2α)-VI(11-16 years post CALERIE trial)
  • Creatinine(11-16 years post CALERIE trial)
  • Dehydroepiandrosterone (DHEA)(11-16 years post CALERIE trial)
  • Interleukin 1 beta (IL-1b)(11-16 years post CALERIE trial)
  • Interleukin 8 (IL-8)(11-16 years post CALERIE trial)
  • Tumor necrosis factor α (TNF-α)(11-16 years post CALERIE trial)
  • Insulin-like growth factor-binding protein 1 (IGFBP-1)(11-16 years post CALERIE trial)
  • Transforming growth factor beta 1 (TGFB1)(11-16 years post CALERIE trial)
  • Insulin-like growth factor-binding protein 3 (IGFBP-3)(11-16 years post CALERIE trial)
  • Platelet-derived growth factor-AB (PDGF-AB)(11-16 years post CALERIE trial)
  • Intercellular Adhesion Molecule 1 (ICAM-1)(11-16 years post CALERIE trial)
  • Growth hormone(11-16 years post CALERIE trial)
  • Monocyte Chemoattractant Protein 1 (MCP1)(11-16 years post CALERIE trial)
  • Leptin(11-16 years post CALERIE trial)
  • Total adiponectin(11-16 years post CALERIE trial)
  • High molecular weight adiponectin(11-16 years post CALERIE trial)
  • Muscle strength - Knee extension (60°)(11-16 years post CALERIE trial)
  • Muscle strength - Knee extension (180°)(11-16 years post CALERIE trial)
  • Muscle strength - Knee flexion (60°)(11-16 years post CALERIE trial)
  • Muscle strength - Knee flexion (180°)(11-16 years post CALERIE trial)
  • Handgrip Strength(11-16 years post CALERIE trial)
  • Physical functioning(11-16 years post CALERIE trial)
  • Resilience(11-16 years post CALERIE trial)
  • Cognition(11-16 years post CALERIE trial)
  • Dietary intake - calories(11-16 years post CALERIE trial)
  • Dietary intake - carbohydrates(11-16 years post CALERIE trial)
  • Dietary intake - proteins(11-16 years post CALERIE trial)
  • Health-related quality of life(11-16 years post CALERIE trial)
  • Depression status(11-16 years post CALERIE trial)
  • Mood(11-16 years post CALERIE trial)
  • Sleep(11-16 years post CALERIE trial)
  • Sexual function(11-16 years post CALERIE trial)
  • Food cravings(11-16 years post CALERIE trial)
  • Dietary restraint, disinhibition, and hunger(11-16 years post CALERIE trial)
  • Disordered eating(11-16 years post CALERIE trial)
  • Body shape perceptions(11-16 years post CALERIE trial)
  • Physical activity(11-16 years post CALERIE trial)
  • Total cholesterol(11-16 years post CALERIE trial)
  • High-density lipoprotein cholesterol (HDL-C)(11-16 years post CALERIE trial)
  • Triglycerides(11-16 years post CALERIE trial)
  • Low-density lipoprotein cholesterol (LDL-C)(11-16 years post CALERIE trial)
  • Glucose - 0 min (OGTT)(11-16 years post CALERIE trial)
  • Glucose - 30 min (OGTT)(11-16 years post CALERIE trial)
  • Glucose - 60 min (OGTT)(11-16 years post CALERIE trial)
  • Glucose - 90 min (OGTT)(11-16 years post CALERIE trial)
  • Glucose - 120 min (OGTT)(11-16 years post CALERIE trial)
  • Insulin resistance(11-16 years post CALERIE trial)
  • Beta-cell function(11-16 years post CALERIE trial)
  • Insulinogenic Index(11-16 years post CALERIE trial)
  • Insulin Sensitivity Index (ISI)(11-16 years post CALERIE trial)
  • Oral Disposition Index(11-16 years post CALERIE trial)
  • Triiodothyronine (T3)(11-16 years post CALERIE trial)
  • Thyroxine (T4)(11-16 years post CALERIE trial)
  • Thyroid stimulating hormone (TSH)(11-16 years post CALERIE trial)
  • Alkaline phosphatase (ALKP)(11-16 years post CALERIE trial)
  • Alanine transaminase (ALT)(11-16 years post CALERIE trial)
  • Aspartate aminotransferase (AST)(11-16 years post CALERIE trial)
  • Albumin(11-16 years post CALERIE trial)
  • Blood Urea Nitrogen (BUN)(11-16 years post CALERIE trial)
  • Total Proteins(11-16 years post CALERIE trial)
  • Bilirubin(11-16 years post CALERIE trial)
  • Creatine Phosphokinase (CPK)(11-16 years post CALERIE trial)
  • Lactate Dehydrogenase (LDH)(11-16 years post CALERIE trial)
  • Globulin(11-16 years post CALERIE trial)
  • Albumin/Globulin (A/G) ratio(11-16 years post CALERIE trial)
  • Uric Acid(11-16 years post CALERIE trial)
  • Calcium (Ca)(11-16 years post CALERIE trial)
  • Phosphorus (P)(11-16 years post CALERIE trial)
  • Magnesium (Mg)(11-16 years post CALERIE trial)
  • Sodium (Na+)(11-16 years post CALERIE trial)
  • Potassium (K+)(11-16 years post CALERIE trial)
  • Chloride (Cl-)(11-16 years post CALERIE trial)
  • Apoprotein A1(11-16 years post CALERIE trial)
  • Apoprotein B(11-16 years post CALERIE trial)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sai Krupa Das

Professor

Tufts University

Study Sites (3)

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