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
Results First Received: December 30, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Dietary Proteins
Interventions: Behavioral: High Protein Diet
Behavioral: Low Protein Diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were assigned to either the High or Low Calcium diets. The subjects then consumed the high and low protein diets in random order, i.e. half of the subjects consumed high protein, then low protein while the other half consumed low protein, then the high protein diet. Drop-outs were replaced.

Reporting Groups
  Description
High Calcium Diet Women consumed diets containing 1500 milligrams of calcium daily
Low Calcium Diet Women consumed diets containing 600 milligrams of calcium daily

Participant Flow:   Overall Study
    High Calcium Diet     Low Calcium Diet  
STARTED     17     17  
COMPLETED     14     13  
NOT COMPLETED     3     4  
Withdrawal by Subject                 1                 2  
Protocol Violation                 1                 1  
Loose Stools                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
High Calcium Diet Women consumed diets containing 1500 milligrams of calcium daily
Low Calcium Diet Women consumed diets containing 600 milligrams of calcium daily
Total Total of all reporting groups

Baseline Measures
    High Calcium Diet     Low Calcium Diet     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     14     30  
>=65 years     1     3     4  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 5     58  ± 6     57  ± 5  
Gender  
[units: participants]
     
Female     17     17     34  
Male     0     0     0  



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

2.  Secondary:   Serum Insulin-like Growth Factor 1 (IGF-1)   [ Time Frame: 7 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Janet Hunt, PhD
Organization: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Reserch Center
phone: 701-795-8353
e-mail: janetrhunt@gmail.com


No publications provided


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
Study First Received: June 18, 2008
Results First Received: December 30, 2008
Last Updated: May 31, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration