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:
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
  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)
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)
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943215

Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Eric Ravussin, PhD Pennington Biomedical Research Center
  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 April 17, 2014