Caloric Restriction and Body Weight in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maciej Buchowski, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00808275
First received: December 12, 2008
Last updated: December 2, 2011
Last verified: December 2011

December 12, 2008
December 2, 2011
September 2004
September 2006   (final data collection date for primary outcome measure)
Fat in stool as a percentage of fat intake [ Time Frame: 3 months of diet ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00808275 on ClinicalTrials.gov Archive Site
Weight change [ Time Frame: 3 months of diet ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Caloric Restriction and Body Weight in Adults
Effect of Dietary Calcium on Body Weight Regulation in Adults

The purpose of this study is to determine the role of

  1. dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.
  2. caloric restriction on biomarkers of inflammation and oxidative stress
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Overweight
Dietary Supplement: Dietary calcium
Dairy and non-dairy calcium provided as a part of diet in the amounts of 500 mg/day and 1500 mg/day. Diet contained 70% of daily caloric requirements.
  • Experimental: Dairy calcium
    Diet with dairy calcium sources
    Intervention: Dietary Supplement: Dietary calcium
  • Experimental: Non-dairy calcium
    Diet with non-dairy calcium sources
    Intervention: Dietary Supplement: Dietary calcium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
October 2007
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 -65 years old
  • Healthy

Exclusion Criteria:

  • Body weight more than 300 lbs (body composition measurement instrument limit) diabetes
  • Heart disease
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00808275
010590
Yes
Maciej Buchowski, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Maciej Buchowski, Ph.D. Vanderbilt University
Vanderbilt University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP