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

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ClinicalTrials.gov Identifier: NCT01256840
Recruitment Status : Completed
First Posted : December 9, 2010
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Cross-Sectional
Condition Aging
Enrollment 71
Recruitment Details Calorie Restriction (CR) participants were recruited from the CR Society International, followers of the CR Way, and by referral from participants.
Pre-assignment Details 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.
Arm/Group Title Calorie Restricting Group Normal-eating Controls Obese Comparison Group
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 30 16 25
Completed 30 16 25
Not Completed 0 0 0
Arm/Group Title Calorie Restricting Group Normal-eating Controls Obese Comparison Group Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 30 16 25 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 16 participants 25 participants 71 participants
54.64  (15.38) 49.33  (12.49) 58.84  (13.98) 55.01  (14.53)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 15 participants 25 participants 69 participants
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]
Measure Analysis Population Description: 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] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 29 participants 15 participants 25 participants 69 participants
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]
Measure Analysis Population Description: Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 16 participants 25 participants 71 participants
28
  93.3%
16
 100.0%
25
 100.0%
69
  97.2%
United Kingdom Number Analyzed 30 participants 16 participants 25 participants 71 participants
1
   3.3%
0
   0.0%
0
   0.0%
1
   1.4%
Japan Number Analyzed 30 participants 16 participants 25 participants 71 participants
1
   3.3%
0
   0.0%
0
   0.0%
1
   1.4%
Highest Degree  
Measure Type: Count of Participants
Unit of measure:  Participants
High School Number Analyzed 30 participants 16 participants 25 participants 71 participants
2
   6.7%
0
   0.0%
1
   4.0%
3
   4.2%
Some college Number Analyzed 30 participants 16 participants 25 participants 71 participants
2
   6.7%
1
   6.3%
3
  12.0%
6
   8.5%
Bachelor's Number Analyzed 30 participants 16 participants 25 participants 71 participants
5
  16.7%
6
  37.5%
2
   8.0%
13
  18.3%
Master's Number Analyzed 30 participants 16 participants 25 participants 71 participants
6
  20.0%
5
  31.3%
2
   8.0%
13
  18.3%
Doctoral Number Analyzed 30 participants 16 participants 25 participants 71 participants
14
  46.7%
2
  12.5%
11
  44.0%
27
  38.0%
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 30 participants 16 participants 25 participants 71 participants
19.07  (1.84) 23.27  (90.21) 29.03  (3.38) 23.52  (5.07)
Cytomegalovirus seropositive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 16 participants 25 participants 71 participants
13
  43.3%
7
  43.8%
13
  52.0%
33
  46.5%
1.Primary Outcome
Title Telomere Length
Hide Description This study is not a clinical trial, but the UCSF Committee on Human Research requires registration with clinicaltrials.gov. It is a ONE TIME POINT study, where we get a simple blood draw from people from three groups - calorie restricting, normal eating, and obese. Therefore, there IS NO FOLLOW UP/time frame. The outcome measure is assessed on the day of the study. Telomere length is a marker of cellular aging and is used to understand how the cells are aging. We will investigate whether long-term caloric restriction is associated cross-sectionally with longer telomere length (less aging).
Time Frame One day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Calorie Restricting Group Normal-eating Controls Obese Comparison Group
Hide Arm/Group Description:
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.
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.
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.
Overall Number of Participants Analyzed 30 16 25
Mean (Standard Deviation)
Unit of Measure: ratio
Telomere T/S ratio - peripheral blood mononuclear 0.96  (0.18) 1.06  (0.15) 1.06  (0.23)
Telomere T/S ratio - granulocyte 1.22  (0.21) 1.20  (0.23) 1.14  (0.22)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calorie Restricting Group Normal-eating Controls Obese Comparison Group
Hide Arm/Group Description 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. 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. 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.
All-Cause Mortality
Calorie Restricting Group Normal-eating Controls Obese Comparison Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/16 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Calorie Restricting Group Normal-eating Controls Obese Comparison Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/16 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calorie Restricting Group Normal-eating Controls Obese Comparison Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/16 (0.00%)   0/25 (0.00%) 
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
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