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Completed

NCT Number: NCT00099151

CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy

This study is one of three CALERIE trials that test the hypothesis that a reduced calorie, nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies.

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center, 6400 Perkins Road

Baton Rouge, Louisiana, 70808, United States

About this study

This study tests whether chronic caloric restriction improves risk factors of longevity in humans as it is known to do in animals, by measuring a variety of factors dealing with metabolism and oxidative stress, through physical evaluations and laboratory tests.

Participants will receive dietary counseling and free medical evaluations. In addition, each volunteer will be asked to do one of the following:

  • Follow a reduced calorie diet
  • Follow a reduced calorie diet using a liquid diet
  • Increase physical activity while on a reduced calorie diet
  • Follow a standard diet.

Three separate five-day inpatient stays are required.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Resident of greater Baton Rouge area for 1 year or longer
  • Men between ages 25-50
  • Women between ages 25-45
  • Body Mass Index (BMI) between 25-30 (never having had BMI greater than 32)
  • Healthy, non-smokers with no history of cardiovascular disease, high blood pressure, diabetes, eating disorder, or major psychiatric disorder

Exclusion criteria

  • Pregnant or breastfeeding
  • Personal history of cardiovascular disease or elevated high blood pressure (higher than 160/90 mmHg)
  • Abnormal electrocardiogram (EKG)
  • Personal history of diabetes
  • Personal history of major psychiatric disorders
  • Personal history of eating disorder
  • Smoking
  • Exercising regularly (more than twice a week)
  • Individuals with alcoholism or other substance abuse
  • Post obese (never have had a BMI greater than 32)
  • Regular use of medications, except oral contraceptives
  • Individuals who were ever injured by a metallic foreign body which was not removed
  • Individuals who wear braces on their teeth, have non-removable false teeth, or non-removable bridgework
  • Individuals in occupations requiring full alertness and motor skills (airline pilots, etc.) where even a small chance of postural dizziness would be unacceptable.

Treatment and study plan

Caloric Restriction (CR)

Behavioral

Exercise

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Official study title

Metabolic Adaptations to Six Month Caloric Restriction

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Dec 9, 2004
Registry last updated
Dec 11, 2009

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.

Published trials that share one or more normalized conditions with this study.