Clinical Trials Directory

Trials / Completed

CompletedNCT00700804

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
USDA Grand Forks Human Nutrition Research Center · Federal
Sex
Female
Age
50 Years – 80 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHigh Protein DietHigh and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm
BEHAVIORALLow Protein DietHigh and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm

Timeline

Start date
2003-06-01
Primary completion
2004-07-01
Completion
2005-01-01
First posted
2008-06-19
Last updated
2018-07-02
Results posted
2009-06-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00700804. Inclusion in this directory is not an endorsement.