How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of Calorie Restriction
This study is enrolling participants by invitation only.
Sponsor:
Pennington Biomedical Research Center
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00943215
First received: July 20, 2009
Last updated: December 7, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Caloric Restriction |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only |
| 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. |
Further study details as provided by Pennington Biomedical Research Center:
Primary Outcome Measures:
- Calorie Restriction [ Time Frame: 2-year ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 65 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 21 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Participants that completeded the CALERIE II study at Pennington Biomedical Research Center.
Criteria
Inclusion Criteria:
- You may qualify to participate in this study only if you completed the CALERIE II study at Pennington Biomedical Research Center.
Exclusion Criteria:
- If you were not a participant in CALERIE II at Pennington Biomedical Research Center, you are ineligible.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Eric Ravussin, Princiapal Investigator, Pennington Biomedical Research Center |
| ClinicalTrials.gov Identifier: | NCT00943215 History of Changes |
| Other Study ID Numbers: | CALERIE II 2-Year Follow-Up, NIA U01 AG20478 |
| Study First Received: | July 20, 2009 |
| Last Updated: | December 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pennington Biomedical Research Center:
|
CALERIE II Follow-up |
ClinicalTrials.gov processed this record on May 22, 2013