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

Not Applicable

Completed

• Conditions: Dietary Proteins
• Interventions: Behavioral: High Protein Diet; Behavioral: Low Protein Diet

• Registration Number: NCT00700804
• Lead Sponsor: USDA Grand Forks Human Nutrition Research Center

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.

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-07
• Study Completion: 2005-01
• Study First Submitted: 2008-06-18
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Results First Submitted: 2008-12-30
• Results First Submitted QC: 2009-04-09
• Results First Posted: 2009-06-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-24
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High Calcium Diet	High Protein Diet	-
Low Calcium Diet	Low Protein Diet	-

Primary Outcome Measures

Name	Time	Method
Calcium Absorption	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

Name	Time	Method
Serum Insulin-like Growth Factor 1 (IGF-1)	7 weeks

Trial Locations

Locations (1)

United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center; 🇺🇸 Grand Forks, North Dakota, United States