Excessive Diet RestrictionCALERIE2-FUNCT00943215
How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction
An observational study of Excessive Diet Restriction, run by Pennington Biomedical Research Center.
Trial summary
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Excessive Diet Restriction
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants that completeded the CALERIE II study at Pennington Biomedical Research Center.
Who may be able to join
- You may qualify to participate in this study only if you completed the CALERIE II study at Pennington Biomedical Research Center.
Who cannot join
- If you were not a participant in CALERIE II at Pennington Biomedical Research Center, you are ineligible.
About this study
Official title: The Proposed Study Entails a Follow-up of All the Completers for 2 Years With Visits Timed 3, 6, 12 and 24 Months After Completion of the 2-year CALERIE II Intervention.
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.
Read the detailed description
You will not be assigned to any particular group during the Follow-Up Study. In the Follow-Up study there is no diet intervention. You will not be asked to follow a calorie-restricted diet or any other diet.
Month 3 and Month 6 (Outpatient Visits)following procedures performed:
- Blood pressure, heart rate, temperature, Weight \& Waist Measurement
- Medication and medical history
- Blood draw (approximately ½ cup)
- DEXA and QuickScan
- Psychological assessment questionnaires reviewed for completeness
- Body Acceptability Morph Test (BAM)
- Review of 7-day food diary
Month 12 and Month 24 (Outpatient Visits) procedures performed:
- Collection of 4 urine samples
- Dosing with doubly labeled water (DLW)
- DEXA and QuickScan
- Eat breakfast and lunch
- Receive 7-day food diary
- Psychological assessment questionnaires
- Body Acceptability Morph Test (BAM)
Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures performed:
- Collection of 2 urine samples
- Blood pressure, heart rate, temperature, Weight \& Waist Measurement
- Blood draw (approximately ½ cup)
- Medication and medical history
- Review of 7-day food diary
- Metabolic Chamber
- Resting Metabolic Rate (RMR)
- Conditions
- Excessive Diet Restriction
- Keywords
- CALERIE II Follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Calorie Restriction
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Excessive Diet RestrictionStudies of the same condition, open and under way.
- 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
- Case only
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Ravussin, Pennington Biomedical Research Center
- Investigators
- Eric Ravussin, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943215
- Sponsor's protocol ID
- PBRC 29012
- Other IDs
- NIH U01 AG20478
- Acronym
- CALERIE2-FU
- Status last verified
- Jan 2016
- First submitted
- 20 Jul 2009
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Marlatt KL, Redman LM, Burton JH, Martin CK, Ravussin E. Persistence of weight loss and acquired behaviors 2 y after stopping a 2-y calorie restriction intervention. Am J Clin Nutr. 2017 Apr;105(4):928-935. doi: 10.3945/ajcn.116.146837. Epub 2017 Mar 8.
PubMed 28275127Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
PubMed 24500151
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Proposed Study Entails a Follow-up of All the Completers for 2 Years With Visits Timed 3, 6, 12 and 24 Months After Completion of the 2-year CALERIE II Intervention.
- ClinicalTrials.gov ID
- NCT00943215
- Acronym / sponsor ID
- CALERIE2-FU / PBRC 29012
- Conditions
- Excessive Diet Restriction
- Keywords
- CALERIE II Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
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 gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.
Detailed description
You will not be assigned to any particular group during the Follow-Up Study. In the Follow-Up study there is no diet intervention. You will not be asked to follow a calorie-restricted diet or any other diet.
Month 3 and Month 6 (Outpatient Visits)following procedures performed:
- Blood pressure, heart rate, temperature, Weight \& Waist Measurement
- Medication and medical history
- Blood draw (approximately ½ cup)
- DEXA and QuickScan
- Psychological assessment questionnaires reviewed for completeness
- Body Acceptability Morph Test (BAM)
- Review of 7-day food diary
Month 12 and Month 24 (Outpatient Visits) procedures performed:
- Collection of 4 urine samples
- Dosing with doubly labeled water (DLW)
- DEXA and QuickScan
- Eat breakfast and lunch
- Receive 7-day food diary
- Psychological assessment questionnaires
- Body Acceptability Morph Test (BAM)
Fourteen days after Month 12 and Month 24 (Overnight Inpatient Visits) following procedures performed:
- Collection of 2 urine samples
- Blood pressure, heart rate, temperature, Weight \& Waist Measurement
- Blood draw (approximately ½ cup)
- Medication and medical history
- Review of 7-day food diary
- Metabolic Chamber
- Resting Metabolic Rate (RMR)
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants that completeded the CALERIE II study at Pennington Biomedical Research Center.
Key inclusion criteria (1 listed)
- You may qualify to participate in this study only if you completed the CALERIE II study at Pennington Biomedical Research Center.
Key exclusion criteria (1 listed)
- If you were not a participant in CALERIE II at Pennington Biomedical Research Center, you are ineligible.
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
Calorie Restriction
Time frame: 2-year
The purpose of this study is to gain knowledge about how participants behave and respond on their own after completing a 2-year intervention of calorie restriction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
- Derived from this study: PubMed 28275127Marlatt KL, Redman LM, Burton JH, Martin CK, Ravussin E. Persistence of weight loss and acquired behaviors 2 y after stopping a 2-y calorie restriction intervention. Am J Clin Nutr. 2017 Apr;105(4):928-935. doi: 10.3945/ajcn.116.146837. Epub 2017 Mar 8.
- Derived from this study: PubMed 24500151Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.
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.
Eric Ravussin, PhD principal investigator
Pennington Biomedical Research Center
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Diet Restriction, run by Pennington Biomedical Research Center.
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 1 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 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calorie Restriction (time frame: 2-year). 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 NCT00943215, 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 14 Jan 2016.