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OpenTrials
Completed

NCT Number: NCT00700804

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

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.

Completed

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Key information

Conditions

Dietary Proteins

Age range

50 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center

Grand Forks, North Dakota, 58202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Protein Diet

Behavioral

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

low protein diet

Behavioral

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

Primary outcomes

  1. Calcium Absorption

    Time frame: 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 outcomes

  1. Serum Insulin-like Growth Factor 1 (IGF-1)

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

USDA Grand Forks Human Nutrition Research Center

Fed

Collaborators

  • National Cattlemen's Beef Association, a contractor to the Beef Checkoff

Registry information

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Jun 19, 2008
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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