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

Dietary Proteins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700804
• Other study ID #: GFHNRC064
• Secondary ID: IRB-200307-010
• Status: Completed
• Phase: N/A
• Start date: June 2003
• Est. completion date: January 2005

Study information

• Verified date: May 2018
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2005
• Est. primary completion date: July 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dietary Proteins

Intervention

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
• Low Protein Diet
High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm

Locations

Country	Name	City	State
United States	United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (2)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center	National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum Insulin-like Growth Factor 1 (IGF-1)		7 weeks