Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
2 other identifiers
interventional
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 18, 2008
CompletedFirst Posted
Study publicly available on registry
June 19, 2008
CompletedResults Posted
Study results publicly available
June 2, 2009
CompletedJuly 2, 2018
May 1, 2018
1.1 years
June 18, 2008
December 30, 2008
May 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calcium Absorption
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
17 weeks
Secondary Outcomes (1)
Serum Insulin-like Growth Factor 1 (IGF-1)
7 weeks
Study Arms (2)
High Calcium Diet
EXPERIMENTALLow Calcium Diet
EXPERIMENTALInterventions
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- taking prescription medication other than hormone replacement therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, 58202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Janet Hunt, PhD
- Organization
- United States Department of Agriculture (USDA) Grand Forks Human Nutrition Reserch Center
Study Officials
- PRINCIPAL INVESTIGATOR
Janet R Hunt, PhD
USDA Grand Forks Human Nutrition Research Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2008
First Posted
June 19, 2008
Study Start
June 1, 2003
Primary Completion
July 1, 2004
Study Completion
January 1, 2005
Last Updated
July 2, 2018
Results First Posted
June 2, 2009
Record last verified: 2018-05