Trial Outcomes & Findings for Long-term Caloric Restriction and Cellular Aging Markers (NCT NCT01256840)
NCT ID: NCT01256840
Last Updated: 2017-10-13
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
71 participants
Primary outcome timeframe
One day
Results posted on
2017-10-13
Participant Flow
Calorie Restriction (CR) participants were recruited from the CR Society International, followers of the CR Way, and by referral from participants.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
16
|
25
|
|
Overall Study
COMPLETED
|
30
|
16
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
Baseline characteristics by cohort
| Measure |
Calorie Restricting Group
n=30 Participants
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
n=16 Participants
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
n=25 Participants
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
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.64 years
STANDARD_DEVIATION 15.38 • n=30 Participants
|
49.33 years
STANDARD_DEVIATION 12.49 • n=16 Participants
|
58.84 years
STANDARD_DEVIATION 13.98 • n=25 Participants
|
55.01 years
STANDARD_DEVIATION 14.53 • n=71 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=29 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
5 Participants
n=15 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
3 Participants
n=25 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
15 Participants
n=69 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
|
Sex: Female, Male
Male
|
22 Participants
n=29 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
10 Participants
n=15 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
22 Participants
n=25 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
54 Participants
n=69 Participants • Sex information is missing for 2 of the participants - one in the CR group and one in the normal eating group.
|
|
Race/Ethnicity, Customized
Race · White
|
26 Participants
n=29 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
13 Participants
n=15 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
24 Participants
n=25 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
63 Participants
n=69 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=29 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
2 Participants
n=15 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
1 Participants
n=25 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
6 Participants
n=69 Participants • Race/Ethnicity data is missing for two participants - one in the CR group and one in the Normal Eating group.
|
|
Region of Enrollment
United States
|
28 Participants
n=30 Participants
|
16 Participants
n=16 Participants
|
25 Participants
n=25 Participants
|
69 Participants
n=71 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=30 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=71 Participants
|
|
Region of Enrollment
Japan
|
1 Participants
n=30 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=71 Participants
|
|
Highest Degree
High School
|
2 Participants
n=30 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=71 Participants
|
|
Highest Degree
Some college
|
2 Participants
n=30 Participants
|
1 Participants
n=16 Participants
|
3 Participants
n=25 Participants
|
6 Participants
n=71 Participants
|
|
Highest Degree
Bachelor's
|
5 Participants
n=30 Participants
|
6 Participants
n=16 Participants
|
2 Participants
n=25 Participants
|
13 Participants
n=71 Participants
|
|
Highest Degree
Master's
|
6 Participants
n=30 Participants
|
5 Participants
n=16 Participants
|
2 Participants
n=25 Participants
|
13 Participants
n=71 Participants
|
|
Highest Degree
Doctoral
|
14 Participants
n=30 Participants
|
2 Participants
n=16 Participants
|
11 Participants
n=25 Participants
|
27 Participants
n=71 Participants
|
|
Body Mass Index
|
19.07 kg/m^2
STANDARD_DEVIATION 1.84 • n=30 Participants
|
23.27 kg/m^2
STANDARD_DEVIATION 90.21 • n=16 Participants
|
29.03 kg/m^2
STANDARD_DEVIATION 3.38 • n=25 Participants
|
23.52 kg/m^2
STANDARD_DEVIATION 5.07 • n=71 Participants
|
|
Cytomegalovirus seropositive
|
13 Participants
n=30 Participants
|
7 Participants
n=16 Participants
|
13 Participants
n=25 Participants
|
33 Participants
n=71 Participants
|
PRIMARY outcome
Timeframe: One dayThis 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).
Outcome measures
| Measure |
Calorie Restricting Group
n=30 Participants
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
n=16 Participants
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
n=25 Participants
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.
|
|---|---|---|---|
|
Telomere Length
Telomere T/S ratio - peripheral blood mononuclear
|
0.96 ratio
Standard Deviation 0.18
|
1.06 ratio
Standard Deviation 0.15
|
1.06 ratio
Standard Deviation 0.23
|
|
Telomere Length
Telomere T/S ratio - granulocyte
|
1.22 ratio
Standard Deviation 0.21
|
1.20 ratio
Standard Deviation 0.23
|
1.14 ratio
Standard Deviation 0.22
|
Adverse Events
Calorie Restricting Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal-eating Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese Comparison Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place