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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dietary Proteins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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High Calcium Diet

Group Type EXPERIMENTAL

High Protein Diet

Intervention Type BEHAVIORAL

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

Low Calcium Diet

Group Type EXPERIMENTAL

Low Protein Diet

Intervention Type BEHAVIORAL

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

Interventions

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High Protein Diet

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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