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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00700804
First Posted: June 19, 2008
Last Update Posted: June 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cattlemen's Beef Association
Information provided by:
USDA Grand Forks Human Nutrition Research Center
  Purpose
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.

Condition Intervention
Dietary Proteins Behavioral: High Protein Diet Behavioral: Low Protein Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Calcium Absorption [ Time Frame: 17 weeks ]
    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


Secondary Outcome Measures:
  • Serum Insulin-like Growth Factor 1 (IGF-1) [ Time Frame: 7 weeks ]

Enrollment: 34
Study Start Date: June 2003
Study Completion Date: January 2005
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Calcium Diet 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
Experimental: Low Calcium Diet 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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700804


Locations
United States, North Dakota
United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202
Sponsors and Collaborators
United States Department of Agriculture (USDA)
National Cattlemen's Beef Association
Investigators
Principal Investigator: Janet R Hunt, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

Responsible Party: Janet R Hunt, PhD, Research Nutritionist, United States Department of Agriculture (USDA) Grand Forks Human Nutriton Research Center
ClinicalTrials.gov Identifier: NCT00700804     History of Changes
Other Study ID Numbers: GFHNRC064
IRB-200307-010
First Submitted: June 18, 2008
First Posted: June 19, 2008
Results First Submitted: December 30, 2008
Results First Posted: June 2, 2009
Last Update Posted: June 2, 2011
Last Verified: May 2011

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Calcium retention
dietary protein
dietary calcium

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs