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OpenTrials
Completed

NCT Number: NCT00943215

How Participants Behave and Respond on Their Own After Completing a 2-year Intervention of 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.

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Key information

Conditions

Excessive Diet Restriction

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study 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.

Acronym: CALERIE2-FU

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2009
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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