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Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

This study has been completed.
Sponsor:
Collaborator:
National Cattlemen's Beef Association
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00700804
First received: June 18, 2008
Last updated: May 31, 2011
Last verified: May 2011

June 18, 2008
May 31, 2011
June 2003
July 2004   (final data collection date for primary outcome measure)
Calcium Absorption [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time
Calcium retention [ Time Frame: 4 wk ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00700804 on ClinicalTrials.gov Archive Site
Serum Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Bone biomarkers deoxypyridinoline, IFG-1 [ Time Frame: 7 wk ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.

This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Basic Science
Dietary Proteins
  • Behavioral: High Protein Diet
    High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
  • Behavioral: Low Protein Diet
    High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
  • Experimental: High Calcium Diet
    Intervention: Behavioral: High Protein Diet
  • Experimental: Low Calcium Diet
    Intervention: Behavioral: Low Protein Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
January 2005
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • at least 3 years since last menses
  • bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
  • body mass index equal to or less than 35 kilograms/meter squared

Exclusion Criteria:

  • taking prescription medication other than hormone replacement therapy
Female
50 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00700804
GFHNRC064, IRB-200307-010
No
Janet R Hunt, PhD, Research Nutritionist, United States Department of Agriculture (USDA) Grand Forks Human Nutriton Research Center
USDA Beltsville Human Nutrition Research Center
National Cattlemen's Beef Association
Principal Investigator: Janet R Hunt, PhD USDA Grand Forks Human Nutrition Research Center
USDA Grand Forks Human Nutrition Research Center
May 2011

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