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Long-term Caloric Restriction and Cellular Aging Markers (CRONA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01256840
First Posted: December 9, 2010
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: May 12, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition: Aging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Calorie Restriction (CR) participants were recruited from the CR Society International, followers of the CR Way, and by referral from participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Inclusion criteria and indicators for CR were reporting calorie restriction without malnutrition for a minimum of two years, BMI < 24.99, and fasting glucose <80 mg/dL.

Reporting Groups
  Description
Calorie Restricting Group Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant’s self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
Normal-eating Controls We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
Obese Comparison Group We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.

Participant Flow:   Overall Study
    Calorie Restricting Group   Normal-eating Controls   Obese Comparison Group
STARTED   30   16   25 
COMPLETED   30   16   25 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Calorie Restricting Group Inclusion criteria for the CR group were reporting calorie restriction without malnutrition for a minimum of two years and BMI < 24.99. Whenever possible, the President of the CR Way Longevity Center and Vice President for Research of the CR Society International or the Chairman of the Board of The CR Society International and Treasurer and Vice President of the CR Way Longevity Center confirmed each participant’s self-reported duration of and adherence to calorie restriction. Calorie restriction was also verified via four weekly random fasting glucose tests (<80 mg/dL) with Bayer glucometers. Nursing staff verified BMI on-site.
Normal-eating Controls We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
Obese Comparison Group We recruited the comparison groups to match the CR group in age, race/ethnicity, gender, and educational attainment. Additionally, we recruited siblings of CR participants to attempt to control for genetic and environmental factors. All participants were non-smokers, and all were not pregnant.
Total Total of all reporting groups

Baseline Measures
   Calorie Restricting Group   Normal-eating Controls   Obese Comparison Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   16   25   71 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
   54.64  (15.38)   49.33  (12.49)   58.84  (13.98)   55.01  (14.53) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 29   15   25   69 
Female      7  24.1%      5  33.3%      3  12.0%      15  21.7% 
Male      22  75.9%      10  66.7%      22  88.0%      54  78.3% 
[1] Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
Race/Ethnicity, Customized [1] 
[Units: Participants]
Count of Participants
       
Race         
Participants Analyzed 
[Units: Participants]
 29   15   25   69 
White      26  89.7%      13  86.7%      24  96.0%      63  91.3% 
Asian      3  10.3%      2  13.3%      1   4.0%      6   8.7% 
[1] Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
United States   28   16   25   69 
United Kingdom         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
United Kingdom   1   0   0   1 
Japan         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
Japan   1   0   0   1 
Highest Degree 
[Units: Participants]
Count of Participants
       
High School         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
High School   2   0   1   3 
Some college         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
Some college   2   1   3   6 
Bachelor's         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
Bachelor's   5   6   2   13 
Master's         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
Master's   6   5   2   13 
Doctoral         
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
Doctoral   14   2   11   27 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
   19.07  (1.84)   23.27  (90.21)   29.03  (3.38)   23.52  (5.07) 
Cytomegalovirus seropositive 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 30   16   25   71 
   13   7   13   33 


  Outcome Measures

1.  Primary:   Telomere Length   [ Time Frame: One day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. A. Janet Tomiyama
Organization: UCLA Department of Psychology
phone: 3102066875
e-mail: tomiyama@psych.ucla.edu


Publications:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01256840     History of Changes
Other Study ID Numbers: UCSF-CHR-10-01323
First Submitted: December 2, 2010
First Posted: December 9, 2010
Results First Submitted: May 12, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017