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: August 8, 2014
Last verified: August 2014
  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: March 2015
Estimated Primary Completion Date: February 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Pennington Biomedical Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Ravussin, Princiapal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00943215     History of Changes
Other Study ID Numbers: 29012 CALERIE II 2y Follow-Up, NIA U01 AG20478
Study First Received: July 20, 2009
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
CALERIE II Follow-up

ClinicalTrials.gov processed this record on September 22, 2014