AgingCRONANCT01256840
Long-term Caloric Restriction and Cellular Aging Markers
An observational study of Aging, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to see whether people who have restricted the number of calories they eat for a long period of time, compared to normal-eating and obese people, have markers of cellular aging that look younger. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample and Calorie Restriction Society
Who may be able to join
- Calorie restricting group: Self-reported caloric restriction for at least two years
- Calorie restriction group: BMI below 23
- Normal eating control: Normal eating (no history of caloric restriction) for two years
- Normal eating control: BMI below 30
- Obese comparison group: BMI above 30
- Obese comparison group: Normal eating (no history of caloric restriction) for two years
Who cannot join
- Regular smoker for the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94118
About this study
Official title: Caloric Restriction With Optimal Nutrition and Aging Study
The purpose of this study is to see whether people who have restricted the number of calories they eat for a long period of time, compared to normal-eating and obese people, have markers of cellular aging that look younger.
- Conditions
- Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Calorie Restricting Group | Not described | |
| Normal-eating controls | Not described | |
| Obese comparison group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere Length
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).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- A. Janet Tomiyama, Ph.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256840
- Sponsor's protocol ID
- UCSF-CHR-10-01323
- Acronym
- CRONA
- Status last verified
- Oct 2017
- First submitted
- 2 Dec 2010
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Incollingo Belsky AC, Epel ES, Tomiyama AJ. Clues to maintaining calorie restriction? Psychosocial profiles of successful long-term restrictors. Appetite. 2014 Aug;79:106-12. doi: 10.1016/j.appet.2014.04.006. Epub 2014 Apr 18.
PubMed 24747211Tomiyama AJ, Milush JM, Lin J, Flynn JM, Kapahi P, Verdin E, Sinclair E, Melov S, Epel ES. Long-term calorie restriction in humans is not associated with indices of delayed immunologic aging: A descriptive study. Nutr Healthy Aging. 2017 Mar 31;4(2):147-156. doi: 10.3233/NHA-160017.
PubMed 28447069
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caloric Restriction With Optimal Nutrition and Aging Study
- ClinicalTrials.gov ID
- NCT01256840
- Acronym / sponsor ID
- CRONA / UCSF-CHR-10-01323
- Conditions
- Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Dec 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 13 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see whether people who have restricted the number of calories they eat for a long period of time, compared to normal-eating and obese people, have markers of cellular aging that look younger.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Calorie Restricting Group | – | – |
| Normal-eating controls | – | – |
| Obese comparison group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample and Calorie Restriction Society
Key inclusion criteria (6 listed)
- Calorie restricting group: Self-reported caloric restriction for at least two years
- Calorie restriction group: BMI below 23
- Normal eating control: Normal eating (no history of caloric restriction) for two years
- Normal eating control: BMI below 30
- Obese comparison group: BMI above 30
Key exclusion criteria (1 listed)
- Regular smoker for the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Telomere Length
Time frame: One day
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24747211Incollingo Belsky AC, Epel ES, Tomiyama AJ. Clues to maintaining calorie restriction? Psychosocial profiles of successful long-term restrictors. Appetite. 2014 Aug;79:106-12. doi: 10.1016/j.appet.2014.04.006. Epub 2014 Apr 18.
- Background: PubMed 28447069Tomiyama AJ, Milush JM, Lin J, Flynn JM, Kapahi P, Verdin E, Sinclair E, Melov S, Epel ES. Long-term calorie restriction in humans is not associated with indices of delayed immunologic aging: A descriptive study. Nutr Healthy Aging. 2017 Mar 31;4(2):147-156. doi: 10.3233/NHA-160017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A. Janet Tomiyama, Ph.D. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of California, San Francisco 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 6 inclusion and 1 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 13 Oct 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Telomere Length (time frame: One day). 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 NCT01256840, which also lists 2 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 13 Oct 2017.