NCT02695511

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

2.8 years

First QC Date

January 13, 2016

Last Update Submit

February 24, 2016

Conditions

Aging

Outcome Measures

Primary Outcomes (2)

  • Change in 24-h Sedentary Energy Expenditure from Baseline

    Measured via Respiratory Chamber

    Baseline, 1 and 2 years

  • Change in 24-h Sleeping Energy Expenditure from Baseline

    Measured via Respiratory Chamber

    Baseline, 1 and 2 years

Secondary Outcomes (2)

  • Change in Oxidative Stress from Baseline

    Baseline, 1 and 2 years

  • Change in Organ/Tissue Size from Baseline

    Baseline, 1 and 2 years

Study Arms (2)

25% CR

EXPERIMENTAL

25% caloric restriction

Other: Caloric restriction

CO (control)

NO INTERVENTION

healthy lifestyle recommendation

Interventions

Caloric restrictionOTHER

25% caloric restriction below baseline energy requirement

25% CR

Eligibility Criteria

Age25 Years - 46 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (4)

  • 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.

    PMID: 34159359DERIVED

  • 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.

    PMID: 30998529DERIVED

  • 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.

    PMID: 29576535DERIVED

  • 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.

    PMID: 27778643DERIVED

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric Ravussin, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2016

First Posted

March 1, 2016

Study Start

May 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 1, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share

Locations

US(1)