Clinical trial NCT05651620: The CALERIE™ Legacy Study
Official title: Legacy Effects of CALERIE™, a 2-year Calorie Restriction Intervention, on Hallmarks of Healthspan and Aging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Calorie Restriction
Keywords: calorie restriction
dietary intervention
biological aging
behavioral data
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Pennington Biomedical Research Center
name: Washington University School of Medicine
name: Duke University
name: National Institute on Aging (NIA)
First posted: 2022-12-15
Enrollment: 216
Sex: ALL
Minimum age (years): 33
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All CALERIE participants, except those who are deceased, are known not to qualify, or did not start their allocated group (CR intervention or ad libitum control) (n = 4), have been identified as potential subjects (n = 216) in the CALERIE Legacy Study. The demographic profile of this study is expected to be similar to that of the CALERIE trial, which was 70.4% female. Healthy individuals without obesity of either sex and all race and ethnic groups were eligible to participate in the CALERIE trial. However, due to safety concerns, pregnant women were excluded, and to avoid confounding from peri- and post-menopausal status, the upper age limit for women was 47 years. Upon enrollment, CALERIE participants were 21-50y, 77.3% White, 12% Black, and 10.7% other; ethnicity was 97% non-Hispanic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biological age - Klemera-Doubal Method
timeFrame: 10-15 years post CALERIE trial
measure: Biological age - Homeostatic Dysregulation
timeFrame: 10-15 years post CALERIE trial
measure: Biological age - Levine Phenotypic Age
timeFrame: 10-15 years post CALERIE trial
measure: Healthspan
timeFrame: 10-15 years post CALERIE trial
Secondary outcomes:
measure: Height
timeFrame: 10-15 years post CALERIE trial
measure: Weight
timeFrame: 10-15 years post CALERIE trial
measure: Waist circumference
timeFrame: 10-15 years post CALERIE trial
measure: Hip circumference
timeFrame: 10-15 years post CALERIE trial
measure: Body mass index (BMI)
timeFrame: 10-15 years post CALERIE trial
measure: Blood pressure
timeFrame: 10-15 years post CALERIE trial
measure: Pulse rate at rest
timeFrame: 10-15 years post CALERIE trial
measure: Respiration rate at rest
timeFrame: 10-15 years post CALERIE trial
measure: Fat mass
timeFrame: 10-15 years post CALERIE trial
measure: Fat-free mass
timeFrame: 10-15 years post CALERIE trial
measure: Bone mineral content
timeFrame: 10-15 years post CALERIE trial
measure: Resting metabolic rate (RMR)
timeFrame: 10-15 years post CALERIE trial
measure: Respiratory quotient (RQ)
timeFrame: 10-15 years post CALERIE trial
measure: Maximal aerobic capacity (V̇O2max)
timeFrame: 10-15 years post CALERIE trial
measure: Interleukin-6 (IL-6)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin - TAME panel
timeFrame: 10-15 years post CALERIE trial
measure: Insulin - 0 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin - 30 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin - 60 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin - 90 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin - 120 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin-like growth factor 1 (IGF-1)
timeFrame: 10-15 years post CALERIE trial
measure: Hemoglobin A1c (HbA1c)
timeFrame: 10-15 years post CALERIE trial
measure: Tumor necrosis factor α receptor II (TNFRII)
timeFrame: 10-15 years post CALERIE trial
measure: High-sensitivity C-reactive protein (hsCRP)
timeFrame: 10-15 years post CALERIE trial
measure: Growth/differentiation factor 15 (GDF15)
timeFrame: 10-15 years post CALERIE trial
measure: Cystatin C
timeFrame: 10-15 years post CALERIE trial
measure: N-terminal B-type natriuretic peptide (NT-proBNP)
timeFrame: 10-15 years post CALERIE trial
measure: Senescence-associated secretory phenotype (SASP) proteins
timeFrame: 10-15 years post CALERIE trial
measure: Urinary Isoprostanes - iPF(2α)-III
timeFrame: 10-15 years post CALERIE trial
measure: Urinary Isoprostanes - 2,3-dinor-iPF(2α)-III
timeFrame: 10-15 years post CALERIE trial
measure: Urinary Isoprostanes - iPF(2α)-VI
timeFrame: 10-15 years post CALERIE trial
measure: Urinary Isoprostanes - 8,12-iso-iPF(2α)-VI
timeFrame: 10-15 years post CALERIE trial
measure: Creatinine
timeFrame: 10-15 years post CALERIE trial
measure: Dehydroepiandrosterone (DHEA)
timeFrame: 10-15 years post CALERIE trial
measure: Interleukin 1 beta (IL-1b)
timeFrame: 10-15 years post CALERIE trial
measure: Interleukin 8 (IL-8)
timeFrame: 10-15 years post CALERIE trial
measure: Tumor necrosis factor α (TNF-α)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin-like growth factor-binding protein 1 (IGFBP-1)
timeFrame: 10-15 years post CALERIE trial
measure: Transforming growth factor beta 1 (TGFB1)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin-like growth factor-binding protein 3 (IGFBP-3)
timeFrame: 10-15 years post CALERIE trial
measure: Platelet-derived growth factor-AB (PDGF-AB)
timeFrame: 10-15 years post CALERIE trial
measure: Intercellular Adhesion Molecule 1 (ICAM-1)
timeFrame: 10-15 years post CALERIE trial
measure: Growth hormone
timeFrame: 10-15 years post CALERIE trial
measure: Monocyte Chemoattractant Protein 1 (MCP1)
timeFrame: 10-15 years post CALERIE trial
measure: Leptin
timeFrame: 10-15 years post CALERIE trial
measure: Total adiponectin
timeFrame: 10-15 years post CALERIE trial
measure: High molecular weight adiponectin
timeFrame: 10-15 years post CALERIE trial
measure: Muscle strength - Knee extension (60°)
timeFrame: 10-15 years post CALERIE trial
measure: Muscle strength - Knee extension (180°)
timeFrame: 10-15 years post CALERIE trial
measure: Muscle strength - Knee flexion (60°)
timeFrame: 10-15 years post CALERIE trial
measure: Muscle strength - Knee flexion (180°)
timeFrame: 10-15 years post CALERIE trial
measure: Handgrip Strength
timeFrame: 10-15 years post CALERIE trial
measure: Physical functioning
timeFrame: 10-15 years post CALERIE trial
measure: Cognition
timeFrame: 10-15 years post CALERIE trial
measure: Dietary intake- calories
timeFrame: 10-15 years post CALERIE trial
measure: Dietary intake - carbohydrates
timeFrame: 10-15 years post CALERIE trial
measure: Dietary intake - proteins
timeFrame: 10-15 years post CALERIE trial
measure: Health-related quality of life
timeFrame: 10-15 years post CALERIE trial
measure: Depression status
timeFrame: 10-15 years post CALERIE trial
measure: Mood
timeFrame: 10-15 years post CALERIE trial
measure: Sleep
timeFrame: 10-15 years post CALERIE trial
measure: Sexual function
timeFrame: 10-15 years post CALERIE trial
measure: Food cravings
timeFrame: 10-15 years post CALERIE trial
measure: Dietary restraint, disinhibition, and hunger
timeFrame: 10-15 years post CALERIE trial
measure: Disordered eating
timeFrame: 10-15 years post CALERIE trial
measure: Body shape perceptions
timeFrame: 10-15 years post CALERIE trial
measure: Physical activity
timeFrame: 10-15 years post CALERIE trial
measure: Resilience
timeFrame: 10-15 years post CALERIE trial
measure: Total cholesterol
timeFrame: 10-15 years post CALERIE trial
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: 10-15 years post CALERIE trial
measure: Triglycerides
timeFrame: 10-15 years post CALERIE trial
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 10-15 years post CALERIE trial
measure: Glucose - 0 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Glucose - 30 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Glucose - 60 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Glucose - 90 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Glucose - 120 min (OGTT)
timeFrame: 10-15 years post CALERIE trial
measure: Insulin resistance
timeFrame: 10-15 years post CALERIE trial
measure: Beta-cell function
timeFrame: 10-15 years post CALERIE trial
measure: Triiodothyronine (T3)
timeFrame: 10-15 years post CALERIE trial
measure: Thyroxine (T4)
timeFrame: 10-15 years post CALERIE trial
measure: Thyroid stimulating hormone (TSH)
timeFrame: 10-15 years post CALERIE trial
measure: Alkaline phosphatase (ALKP)
timeFrame: 10-15 years post CALERIE trial
measure: Alanine transaminase (ALT)
timeFrame: 10-15 years post CALERIE trial
measure: Aspartate aminotransferase (AST)
timeFrame: 10-15 years post CALERIE trial
measure: Albumin
timeFrame: 10-15 years post CALERIE trial
measure: Blood Urea Nitrogen (BUN)
timeFrame: 10-15 years post CALERIE trial
measure: Total Proteins
timeFrame: 10-15 years post CALERIE trial
measure: Bilirubin
timeFrame: 10-15 years post CALERIE trial
measure: Creatine Phosphokinase (CPK)
timeFrame: 10-15 years post CALERIE trial
measure: Lactate Dehydrogenase (LDH)
timeFrame: 10-15 years post CALERIE trial
measure: Globulin
timeFrame: 10-15 years post CALERIE trial
measure: Albumin/Globulin (A/G) ratio
timeFrame: 10-15 years post CALERIE trial
measure: Uric Acid
timeFrame: 10-15 years post CALERIE trial
measure: Calcium (Ca)
timeFrame: 10-15 years post CALERIE trial
measure: Phosphorus (P)
timeFrame: 10-15 years post CALERIE trial
measure: Magnesium (Mg)
timeFrame: 10-15 years post CALERIE trial
measure: Sodium (Na+)
timeFrame: 10-15 years post CALERIE trial
measure: Potassium (K+)
timeFrame: 10-15 years post CALERIE trial
measure: Chloride (Cl-)
timeFrame: 10-15 years post CALERIE trial
measure: Apoprotein A1
timeFrame: 10-15 years post CALERIE trial
measure: Apoprotein B
timeFrame: 10-15 years post CALERIE trial
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Tufts University
name: Sai Krupa Das, PhD
role: PRINCIPAL_INVESTIGATOR
References: