CALERIE: Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy

March 14, 2022 updated by: Duke University

Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy (CALERIE)

The purpose of this study is to test the hypothesis that two years of sustained 25% caloric restriction (CR) in men age 21-50 (inclusive) and women age 21-47 (inclusive) will slow aging and protect against age-related disease processes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall aim of CALERIE Phase 2 is to test the hypothesis that two years of sustained caloric restriction (CR), involving a reduction in energy intake to 75% of baseline (25% CR), in healthy, non-obese men aged 21-50 (inclusive) and women aged 21-47 (inclusive), will result in the same adaptive changes that were observed in a wide variety of animal studies. Particular emphasis is on the adaptive responses thought to be involved in slowing the aging process and protecting against age-related disease processes. Primary outcomes include core body temperature and resting metabolic rate. Secondary outcomes include risk factors for cardiovascular disease, inflammatory markers, immune function, psychological and physical function; oxidative changes in lipids, proteins, and DNA; and, risk factors for age-related conditions such as diabetes and body composition. An important secondary aim is to identify potential adverse effects of CR in humans.

The study will be conducted as a multi-center, parallel-group, randomized, controlled trial (RCT). A sample of 200 participants will be enrolled, and assigned to either the CR intervention or a control group. Control participants will be advised to simply continue their current diets. Participants in both treatment arms will be followed over a period of 24 months. A comprehensive set of evaluations will be performed prior to initiating the intervention, with follow-up evaluations at 1, 3, 6, 9, 12, 18 and 24 months afterwards.

Study Type

Interventional

Enrollment (Actual)

238

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age must be between 21-50 (inclusive) for men and 21-47 (inclusive) for women
  • Body mass index (BMI) must be greater than or equal to 22 and less than 28
  • Female participants must use acceptable forms of contraception (barrier method, oral contraceptive, intra-uterine device, or similar) and be willing to continue using such a method while enrolled in the study

Exclusion Criteria:

  • History or clinical manifestation of cardiovascular disease or an elevated blood pressure (greater than 140/90 mm Hg)
  • Abnormal resting ECG
  • History or clinical manifestation of diabetes
  • History or clinical manifestation of cholelithiasis (the presence or formation of gallstones in the gallbladder or bile ducts)
  • History of anaphylaxis, severe allergies, or asthma
  • History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer that, in opinion of the investigator, would make the candidate ineligible for the study
  • History of stomach or intestinal surgery (except appendectomy) or major abdominal, thoracic or non-peripheral vascular surgery within one year prior to the randomization date
  • Any disease or condition that seriously affects body weight and/or body composition
  • Potassium level above the upper limit of normal at the screening visit confirmed by a test repeated within two weeks
  • Hemoglobin, hematocrit, RBC, or iron level below the lower limit of normal at the screening visit confirmed by a test repeated within two weeks
  • Evidence of active liver disease or ALT levels above 1.5 times the upper limit of normal
  • Practice a vegan dietary lifestyle
  • History or clinical manifestation of any eating disorder
  • Any history of pharmacologic treatment for a psychiatric disorder within one year prior to the randomization date or a history of more than one episode of a pharmacologic treatment for a psychiatric disorder within lifetime
  • History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
  • BDI (Beck Depression Inventory) score of 20 or higher at screening or baseline
  • Treatment with steroids for more than a month within five years prior to the randomization date, or short-term (less than a month) treatment with steroids within six months prior to the randomization date
  • Regular use of other medications, except contraceptives
  • Participated in the CALERIE Phase 1 studies
  • Lost or gained 3 kg or more over the past six months
  • A volunteer must be either a never-smoker of tobacco products or an ex-smoker who quit completely at least 12 months prior to the screening visit
  • Donated blood within 30 days prior to the randomization date
  • Concurrent participation in any other interventional study
  • Breast-feeding or pregnant women or women intending to become pregnant before the scheduled end of the intervention
  • Engaged in a regular program of physical fitness involving some kind of heavy physical activity (e.g., jogging, running or riding fast on a bicycle for 30 minutes or more) five or more times per week over the past year
  • Unwilling to be assigned at random to the CR or control intervention
  • Unwilling or unable to adhere to the rigors of the CR intervention over the entire two-year intervention period
  • Unable or unwilling to discontinue dietary supplements or adhere to the alcohol consumption restrictions during the study
  • Unwilling or unable to adhere to the rigors of the data collection and clinical evaluation schedule over the entire two-year period follow-up period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caloric Restriction (CR)
25% caloric restriction
Behavioral: Caloric Restriction (CR)
Participants follow a diet with 25% fewer calories than calculated at baseline over a period of 24 months
Active Comparator: Control, Ad libitum (AL)
Ad libitum energy intake
Behavioral: Control
Participants continue their current diet for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Core Body Temperature, Baseline to 12 Months
Time Frame: Baseline to 12 months
Baseline to 12 months
Change in Core Temperature, Baseline to 24 Months
Time Frame: Baseline to 24 months
Baseline to 24 months
Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition, Baseline to 12 Months
Time Frame: Baseline, 12 months
Baseline, 12 months
Change in Resting Metabolic Rate (RMR) Corrected for Changes in Body Composition
Time Frame: Baseline, 24 months
Baseline, 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Tumor Necrosis Factor-α (TNF-α), Baseline to 12 Months
Time Frame: change baseline to 12 months
change baseline to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fat Mass
Time Frame: change 0 to 24 months
Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.
change 0 to 24 months
Change in Fat Mass
Time Frame: baseline, 12 months
Difference in change in Fat Mass between prescribed 25% Caloric Restriction (CR) and Ad Libitum (AL) at 12 and 24 months as measured by dual X-ray absorptiometry (DXA) using the Hologic 4500A, Delphi W or Discovery A, by a standardized protocol according to a standardized protocol. Fat Mass (FM) was determined for the whole body.
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: William Kraus, MD, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 26, 2007

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00016876
  • PBRC U01-AG0204878
  • Tufts U01-AG020480
  • WashU U01-AG020487
  • DCRI/Duke U01-AG022132
  • AG0078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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