The CALERIE™ Legacy Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Calorie Restriction

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 Type: Observational
• Enrollment (Estimated): 216

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological age - Klemera-Doubal Method	Biological age will be quantified by the Klemera-Doubal Method (KDM), an algorithm-based measure. Biological age is expressed in years.	10-15 years post CALERIE trial
Healthspan	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.	10-15 years post CALERIE trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological age - Homeostatic Dysregulation	Biological age will be quantified by homeostatic dysregulation, an algorithm-based measure. Biological age is expressed in years.	10-15 years post CALERIE trial
Biological age - Levine Phenotypic Age	Biological age will be quantified by Levine Phenotypic Age, an algorithm-based measure. Biological age is expressed in years.	10-15 years post CALERIE trial
Height	Height will be measured in cm.	10-15 years post CALERIE trial
Weight	Weight will be measured in kg.	10-15 years post CALERIE trial
Waist circumference	Weight circumference will be measured in cm.	10-15 years post CALERIE trial
Hip circumference	Hip circumference will be measured in cm.	10-15 years post CALERIE trial
Body mass index (BMI)	BMI (kg/m2) will be calculated using height and weight measurements.	10-15 years post CALERIE trial
Pulse rate at rest	Pulse rate will be measured in beats/min.	10-15 years post CALERIE trial
Respiration rate at rest	Respiration rate will be measured in breaths/min.	10-15 years post CALERIE trial
Fat mass	Whole-body fat mass (%) as measured by dual-energy X-ray absorptiometry.	10-15 years post CALERIE trial
Fat-free mass	Whole-body fat-free mass (%) as measured by dual-energy X-ray absorptiometry.	10-15 years post CALERIE trial
Bone mineral content	Whole-body bone mineral content (g/cm2) as measured by dual-energy X-ray absorptiometry.	10-15 years post CALERIE trial
Resting metabolic rate (RMR)	RMR will be measured in kcal/d by indirect calorimetry using a ventilated hood system.	10-15 years post CALERIE trial
Respiratory quotient (RQ)	RQ will be measured by indirect calorimetry using a ventilated hood system. This is a ratio and does not have a unit.	10-15 years post CALERIE trial
Maximal aerobic capacity (V̇O2max)	Maximal aerobic capacity (V̇O2max) will be measured in mL/kg/min using the Cornell incremental treadmill test.	10-15 years post CALERIE trial
Interleukin-6 (IL-6)	IL-6, a blood-based biomarker of aging proposed by the Targeting Aging with MEtformin (TAME) Biomarkers Workgroup, will be measured in pg/mL.	10-15 years post CALERIE trial
Insulin - TAME panel	Insulin, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in μIU/mL.	10-15 years post CALERIE trial
Insulin - 0 min (OGTT)	Insulin (μIU/mL) will be measured at 0 minutes (pre-dose) during an oral glucose tolerance test (OGTT) to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Insulin - 30 min (OGTT)	Insulin (μIU/mL) will be measured at 30 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Insulin - 60 min (OGTT)	Insulin (μIU/mL) will be measured at 60 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Insulin - 90 min (OGTT)	Insulin (μIU/mL) will be measured at 90 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Insulin - 120 min (OGTT)	Insulin (μIU/mL) will be measured at 120 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Insulin-like growth factor 1 (IGF-1)	IGF-1, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in ng/mL.	10-15 years post CALERIE trial
Hemoglobin A1c (HbA1c)	HbA1c, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in mmol/mol.	10-15 years post CALERIE trial
Tumor necrosis factor α receptor II (TNFRII)	TNFRII, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in ng/mL.	10-15 years post CALERIE trial
High-sensitivity C-reactive protein (hsCRP)	hsCRP, a blood-based biomarker of inflammation, will be measured in μg/mL.	10-15 years post CALERIE trial
Growth/differentiation factor 15 (GDF15)	GDF15, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in pg/mL.	10-15 years post CALERIE trial
Cystatin C	Cystatin C, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in mg/L.	10-15 years post CALERIE trial
N-terminal B-type natriuretic peptide (NT-proBNP)	NT-proBNP, a blood-based biomarker of aging proposed by the TAME Biomarkers Workgroup, will be measured in pg/mL.	10-15 years post CALERIE trial
Senescence-associated secretory phenotype (SASP) proteins	SASP proteins, blood-based biomarkers of cellular senescence, will be measured using a SASP panel.	10-15 years post CALERIE trial
Urinary Isoprostanes - iPF(2α)-III	Urinary iPF(2α)-III, a biomarker of systemic oxidative stress, will be measured in ng/mL.	10-15 years post CALERIE trial
Urinary Isoprostanes - 2,3-dinor-iPF(2α)-III	Urinary 2,3-dinor-iPF(2α)-III, a biomarker of systemic oxidative stress, will be measured in ng/mL.	10-15 years post CALERIE trial
Urinary Isoprostanes - iPF(2α)-VI	Urinary iPF(2α)-VI, a biomarker of systemic oxidative stress, will be measured in ng/mL.	10-15 years post CALERIE trial
Urinary Isoprostanes - 8,12-iso-iPF(2α)-VI	Urinary 8,12-iso-iPF(2α)-VI, a biomarker of systemic oxidative stress, will be measured in ng/mL.	10-15 years post CALERIE trial
Creatinine	Creatinine, a byproduct of routine activity in the muscle, will be measured in urine in mg/mL.	10-15 years post CALERIE trial
Dehydroepiandrosterone (DHEA)	DHEA, a blood-based steroid hormone, will be measured in μg/dL.	10-15 years post CALERIE trial
Interleukin 1 beta (IL-1b)	IL-1b, a blood-based marker of inflammation, will be measured in pg/mL.	10-15 years post CALERIE trial
Interleukin 8 (IL-8)	IL-8, a blood-based marker of inflammation, will be measured in pg/mL.	10-15 years post CALERIE trial
Tumor necrosis factor α (TNF-α)	TNF-α, a blood-based marker of inflammation, will be measured in pg/mL.	10-15 years post CALERIE trial
Insulin-like growth factor-binding protein 1 (IGFBP-1)	IGFBP-1, a blood-based transport protein, will be measured in ng/mL.	10-15 years post CALERIE trial
Transforming growth factor beta 1 (TGFB1)	TGFB1, a blood-based marker of immune function, will be measured in ng/mL.	10-15 years post CALERIE trial
Insulin-like growth factor-binding protein 3 (IGFBP-3)	IGFBP-3, a blood-based transport protein, will be measured in ng/mL.	10-15 years post CALERIE trial
Platelet-derived growth factor-AB (PDGF-AB)	PDGF-AB, a blood-based marker of cellular function, will be measured in ng/mL.	10-15 years post CALERIE trial
Intercellular Adhesion Molecule 1 (ICAM-1)	ICAM-1, a blood-based marker of inflammation, will be measured in ng/mL.	10-15 years post CALERIE trial
Growth hormone	Growth hormone, a blood-based bio-marker of cellular function, will be measured in ng/mL.	10-15 years post CALERIE trial
Monocyte Chemoattractant Protein 1 (MCP1)	MCP1, a blood-based marker of inflammation, will be measured in pg/mL.	10-15 years post CALERIE trial
Leptin	Leptin, a hormonal regulator of energy balance, will be measured in pg/mL.	10-15 years post CALERIE trial
Total adiponectin	Total adiponectin, a protein hormone that regulates several metabolic processes, including glucose regulation and fatty acid oxidation, will be measured in μg/mL.	10-15 years post CALERIE trial
High molecular weight adiponectin	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.	10-15 years post CALERIE trial
Muscle strength - Knee extension (60°)	Knee extension at 60 degrees per second will be expressed in Nm.	10-15 years post CALERIE trial
Muscle strength - Knee extension (180°)	Knee extension at 180 degrees per second will be expressed in Nm.	10-15 years post CALERIE trial
Muscle strength - Knee flexion (60°)	Knee flexion at 60 degrees per second will be expressed in Nm.	10-15 years post CALERIE trial
Muscle strength - Knee flexion (180°)	Knee flexion at 180 degrees per second will be expressed in Nm.	10-15 years post CALERIE trial
Physical functioning	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.	10-15 years post CALERIE trial
Cognition	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.	10-15 years post CALERIE trial
Dietary intake- calories	Dietary intake in calories (kcals/day), as measured by multiple-pass 24-hour dietary recalls and Nutrition Data System for Research (NDSR) software.	10-15 years post CALERIE trial
Dietary intake - carbohydrates	Dietary carbohydrate as % of energy or grams will be measured by multiple-pass 24-hour dietary recalls and Nutrition Data System for Research (NDSR) software.	10-15 years post CALERIE trial
Dietary intake - proteins	Dietary proteins as % of energy or grams will be measured by multiple-pass 24-hour dietary recalls and Nutrition Data System for Research (NDSR) software.	10-15 years post CALERIE trial
Health-related quality of life	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.	10-15 years post CALERIE trial
Depression status	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.	10-15 years post CALERIE trial
Mood	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.	10-15 years post CALERIE trial
Sleep	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.	10-15 years post CALERIE trial
Sexual function	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.	10-15 years post CALERIE trial
Food cravings	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.	10-15 years post CALERIE trial
Dietary restraint, disinhibition, and hunger	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).	10-15 years post CALERIE trial
Disordered eating	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).	10-15 years post CALERIE trial
Body shape perceptions	Body shapes 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.	10-15 years post CALERIE trial
Physical activity	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.	10-15 years post CALERIE trial
Resilience	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.	10-15 years post CALERIE trial
Total cholesterol	Total cholesterol will be measured in mg/dL using a standard lipid panel.	10-15 years post CALERIE trial
High-density lipoprotein cholesterol (HDL-C)	HDL-C will be measured in mg/dL using a standard lipid panel.	10-15 years post CALERIE trial
Triglycerides	Triglycerides will be measured in mg/dL using a standard lipid panel.	10-15 years post CALERIE trial
Low-density lipoprotein cholesterol (LDL-C)	LDL-C will be calculated in mg/dL using measured values of total cholesterol, HDL-C, and triglycerides.	10-15 years post CALERIE trial
Glucose - 0 min (OGTT)	Glucose (mg/dL) will be measured at 0 minutes (pre-dose) during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Glucose - 30 min (OGTT)	Glucose (mg/dL) will be measured at 30 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Glucose - 60 min (OGTT)	Glucose (mg/dL) will be measured at 60 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Glucose - 90 min (OGTT)	Glucose (mg/dL) will be measured at 90 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Glucose - 120 min (OGTT)	Glucose (mg/dL) will be measured at 120 minutes post dose during an OGTT to evaluate glucoregulatory response.	10-15 years post CALERIE trial
Insulin resistance	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	10-15 years post CALERIE trial
Beta-cell function	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)	10-15 years post CALERIE trial
Triiodothyronine (T3)	T3, a blood-based marker of thyroid function, will be measured in ng/dL.	10-15 years post CALERIE trial
Thyroxine (T4)	T4, a blood-based marker of thyroid function, will be measured in ng/dL.	10-15 years post CALERIE trial
Thyroid stimulating hormone (TSH)	TSH, a blood-based marker of thyroid function, will be measured in μIU/mL.	10-15 years post CALERIE trial
Alkaline phosphatase (ALKP)	ALKP, a blood-based marker of liver function, will be measured in IU/L.	10-15 years post CALERIE trial
Alanine transaminase (ALT)	ALT, a blood-based marker of liver function, will be measured in U/L.	10-15 years post CALERIE trial
Aspartate aminotransferase (AST)	AST, a blood-based marker of liver function, will be measured in U/L.	10-15 years post CALERIE trial
Blood pressure	Systolic and diastolic blood pressure will be measured in mmHg.	10-15 years post CALERIE trial
Handgrip Strength	Handgrip strength will be measured via a hand dynamometer and expressed in kg.	10-15 years post CALERIE trial
Albumin	Albumin, a blood-based marker of liver and kidney function, will be measured in g/dL.	10-15 years post CALERIE trial
Blood Urea Nitrogen (BUN)	BUN, a blood-based marker of kidney function, will be measured in mg/dL.	10-15 years post CALERIE trial
Total Proteins	Total proteins is a measurement sum of albumin and globulin. Total proteins is indicative of blood vessel and immune system function. It will be measured in g/dL.	10-15 years post CALERIE trial
Bilirubin	Bilirubin, a blood-based marker of liver function, will be measured in mg/dL.	10-15 years post CALERIE trial
Creatine Phosphokinase (CPK)	CPK, an enzyme marker of energy homeostasis, will be measured in U/L.	10-15 years post CALERIE trial
Lactate Dehydrogenase (LDH)	LDH, an enzyme marker of liver function, will be measured in U/L.	10-15 years post CALERIE trial
Globulin	Globulin, a blood-based marker of liver function, will be measured in g/dL.	10-15 years post CALERIE trial
Albumin/Globulin (A/G) ratio	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.	10-15 years post CALERIE trial
Uric Acid	Uric acid, a blood-based marker of purine metabolism, will be measured in mg/dL.	10-15 years post CALERIE trial
Calcium (Ca)	Calcium, a blood-based mineral, will be measured in mg/dL.	10-15 years post CALERIE trial
Phosphorus (P)	Phosphorus, a blood-based mineral, will be measured in mg/dL.	10-15 years post CALERIE trial
Magnesium (Mg)	Magnesium, a blood-based mineral, will be measured in meq/L.	10-15 years post CALERIE trial
Sodium (Na+)	Sodium, an electrolyte that reflects the body's fluid balance, will be measured in meq/L.	10-15 years post CALERIE trial
Potassium (K+)	Potassium, an electrolyte that reflects the body's fluid balance, will be measured in meq/L.	10-15 years post CALERIE trial
Chloride (Cl-)	Chloride, an electrolyte that reflects the body's fluid balance, will be measured in meq/L.	10-15 years post CALERIE trial
Apoprotein A1	Apoprotein A1, a blood-based marker of lipid metabolism, will be measured in mg/dL.	10-15 years post CALERIE trial
Apoprotein B	Apoprotein B, a blood-based marker of lipid metabolism, will be measured in mg/dL.	10-15 years post CALERIE trial

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Washington University School of Medicine; Duke University; National Institute on Aging (NIA); Pennington Biomedical Research Center
• Investigators: Principal Investigator: Sai Krupa Das, PhD, Tufts University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: dietary intervention; calorie restriction; biological aging; behavioral data
• Other Study ID Numbers: STUDY00002577; 1R01AG071717-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Per the NIH Data Public Access Policy, after study closure, the data coordinating center at Duke University will lock the electronic database and clean and deidentify the data prior to public posting. Biospecimens collected for banking will be deidentified and transferred to the NIA AgingResearchBiobank, which utilizes a state-of-the-art inventory system for the storage and distribution of study samples for future scientific research.

The study protocol and informed consent form will be made available as well.

• IPD Sharing Time Frame: Data will be posted for open access use at the time of publication of the primary manuscript. Biospecimens will be stored at the NIA Biobank and will be available upon study completion and until all samples are depleted or deemed not viable.

IPD Sharing Access Criteria

Permission to use data will not be restricted. However, interested investigators must register with the applicable website to access data, which will be made available via download. Data collected in this study will be appropriate for regression adapted to longitudinal data and multivariate-multivariable analysis or goodness-of-fit chi-square, non-parametric measures of association.

Investigators interested in accessing biospecimens will need to apply for access by submitting a request via the NIA AgingResearchBiobank website (https://agingresearchbiobank.nia.nih.gov/how-to-make-a-request/). To submit this request, a designated member of the investigative team will be required to register as a user on the AgingResearchBiobank website. Any investigator can submit a request for access to the biospecimens for future research but must be approved by the AgingResearchBiobank to gain access. Biospecimens will be provided as samples that will be shipped to approved investigators.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No