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AgingPhase 2CALERIE-IINCT02695511

CALERIE Phase II Ancillary: Metabolic

A Phase 2 study testing Caloric restriction in people with Aging, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in normal-weight and slightly overweight individuals. Read more about this study

Who is it for?
Ages 25 to 46 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Caloric restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
May 2007to Feb 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 46 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy men and women
  • > 22 BMI < 28 kg/m2
  • > 25 age < 46

Who cannot join

  • 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, cholelithiasis or any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, eating disorders or cancer
  • 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
Show all 25Show fewer
  • 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
  • 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
  • Individuals who present with a BDI score of =15 at screening or baseline
  • Short-term (less than a month) treatment with steroids within six months prior to the randomization date
  • Treatment with steroids for more than a month within five years prior to the randomization date
  • Regular use of other medications, except oral contraceptives
  • Individuals who participated in the CALERIE Phase 1 studies
  • A volunteer must be either be a never-smoker of tobacco products or an ex-smoker who quit completely at least 12 months prior to the screening visit
  • Individuals who have magnetic metallic objects in their body
  • Individuals who donated blood within 30 days prior to the randomization date
  • Concurrent participation in any other interventional study
  • Pregnant or breast-feeding women
  • Individuals who were 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
  • Individuals who 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

Official title: CALERIE Phase II Ancillary 2: Metabolic Adaptation After Two Years of Caloric Restriction in Non Obese Humans

The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and sleeping) will be measured in a respiratory chamber. Other measures include the activities of the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA, organ size by MRI and echocardiography, and posture allocation (time spent engaging in different activities and the energy expended during these activities), and activity temperament (the innate predilection for movement). This set of studies will allow assessment of whether the previously observed metabolic adaptation in response to 25% caloric restriction is long lasting (up to two years), associated with reduced thyroid and sympathetic activities and reduced oxidative damage. The studies of organ sizes (liver, spleen, kidney, heart, adipose and muscle) by MRI and echo (heart) is essential to determine whether the metabolic adaptation is related to decreased organ sizes or improved organ energy metabolism efficiency. The above described measures will be performed at baseline and after 1 and 2 years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI- and age- matched subjects who will not engage in caloric restriction.

Read the detailed description

Hypothesis 1: The decrease in energy expenditure (sedentary and sleeping) will be larger than that expected on the basis of loss of fat-free mass and fat mass even after weight stabilization. Aim 1: Determine the metabolic adaptation after 1 and 2 years of a 25% CR

Hypothesis 2: The metabolic adaptation (what is not accounted by a decrease in FM and FFM) is not entirely accounted by reduced organ/tissue size (liver, spleen, kidney, heart and brain) but is accompanied by reduced activities of the sympathetic and thyroid systems. Aim 2: Assess the contribution of organ sizes and activities of the thyroid and sympathetic systems to the metabolic adaptation. Results will be compared to in vivo and in vitro oxidative phosphorylation (Smith, PI).

Hypothesis 3: A decrease in markers of oxidative stress to lipid (urinary isoprostanes) DNA (strand breaks) in blood and protein (carbonylation and thiol oxidation) in blood and skeletal muscle tissue after 1 and 2 years of CR will be observed. Aim 3: Determine the changes in oxidative stress after 1 and 2 years of 25% CR by measuring urinary isoprostanes, serum carbonyls, DNA damage in nucleated blood cells and protein oxidation (carbonyls and oxidation of cysteine residues) in skeletal muscle.

Conditions
Aging
Being tested
Caloric restriction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caloric restrictionOther

    25% caloric restriction below baseline energy requirement

Study groups in NCT02695511
Study groupRoleWhat they receive
25% CRExperimental25% caloric restriction
Receives: Other: Caloric restriction
CO (control)No interventionhealthy lifestyle recommendation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24-h Sedentary Energy Expenditure from Baseline

    Measured via Respiratory Chamber

    Measured: Baseline, 1 and 2 years

  2. Change in 24-h Sleeping Energy Expenditure from Baseline

    Measured via Respiratory Chamber

    Measured: Baseline, 1 and 2 years

Secondary outcomes (2)

  1. Change in Oxidative Stress from Baseline

    Measured: Baseline, 1 and 2 years

  2. Change in Organ/Tissue Size from Baseline

    Measured: Baseline, 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2016 (estimated)
  2. Study startMay 2007
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02695511
Sponsor's protocol ID
PBRC 26039-A
Other IDs
R01AG029914
Acronym
CALERIE-II
Status last verified
Feb 2016
First submitted
13 Jan 2016
Last updated
1 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Shen W, Chen J, Zhou J, Martin CK, Ravussin E, Redman LM. Effect of 2-year caloric restriction on organ and tissue size in nonobese 21- to 50-year-old adults in a randomized clinical trial: the CALERIE study. Am J Clin Nutr. 2021 Oct 4;114(4):1295-1303. doi: 10.1093/ajcn/nqab205.

    PubMed 34159359

  • Broskey NT, Marlatt KL, Most J, Erickson ML, Irving BA, Redman LM. The Panacea of Human Aging: Calorie Restriction Versus Exercise. Exerc Sport Sci Rev. 2019 Jul;47(3):169-175. doi: 10.1249/JES.0000000000000193.

    PubMed 30998529

  • Redman LM, Smith SR, Burton JH, Martin CK, Il'yasova D, Ravussin E. Metabolic Slowing and Reduced Oxidative Damage with Sustained Caloric Restriction Support the Rate of Living and Oxidative Damage Theories of Aging. Cell Metab. 2018 Apr 3;27(4):805-815.e4. doi: 10.1016/j.cmet.2018.02.019. Epub 2018 Mar 22.

    PubMed 29576535

  • Sparks LM, Redman LM, Conley KE, Harper ME, Yi F, Hodges A, Eroshkin A, Costford SR, Gabriel ME, Shook C, Cornnell HH, Ravussin E, Smith SR. Effects of 12 Months of Caloric Restriction on Muscle Mitochondrial Function in Healthy Individuals. J Clin Endocrinol Metab. 2017 Jan 1;102(1):111-121. doi: 10.1210/jc.2016-3211.

    PubMed 27778643

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caloric restriction in people with Aging, run by Pennington Biomedical Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-h Sedentary Energy Expenditure from Baseline (time frame: Baseline, 1 and 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02695511, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.

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