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Calcium Retention as Influenced by Dietary Components That Induce an Acid Load

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620763
First Posted: February 21, 2008
Last Update Posted: August 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
USDA Grand Forks Human Nutrition Research Center
  Purpose
The impact of protein sources such as beef as part of Western diet on calcium retention remains controversial. We propose to test the hypothesis that the positive effect of high protein intake (especially from meat protein) can offset the negative effect of protein-induced net acid load on bone metabolism and the retention of body calcium. Healthy postmenopausal women recruited from the community will consume two diets differing in meat protein and acid load for 7 weeks. Calcium retention from diets will be determined using a highly sensitive measurement of whole body retention of a calcium isotope added to the diet.

Condition Intervention
Healthy Other: High Meat - High Potential Renal Acid Load (PRAL) diet Other: Low Protein - Low Potential Renal Acid Load (PRAL) diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Calcium Retention in Postmenopausal Women as Influenced by Beef and Other Dietary Components That Induce an Acid Load

Resource links provided by NLM:


Further study details as provided by USDA Grand Forks Human Nutrition Research Center:

Primary Outcome Measures:
  • Calcium Absorption [ Time Frame: 18 weeks ]
    After 3 weeks equilibration to the diet, the 2-day menu was extrinsically labeled with Calcium-47 radiotracer and retention was monitored for 28 days by whole body scintillation counting. Percent Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic plot of percent Calcium-47 retained vs time.


Enrollment: 22
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dietary Intervention: High meat and high acid load diet followed by low meat and low acid load diet
Other: High Meat - High Potential Renal Acid Load (PRAL) diet
Menu high in meat protein
Other: Low Protein - Low Potential Renal Acid Load (PRAL) diet
Menu low in meat protein
Experimental: B
Dietary Intervention: Low meat and low acid load diet followed by high meat and high acid load diet
Other: High Meat - High Potential Renal Acid Load (PRAL) diet
Menu high in meat protein
Other: Low Protein - Low Potential Renal Acid Load (PRAL) diet
Menu low in meat protein

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Average body mass index
  • Normal blood work
  • Normal bone density

Exclusion Criteria:

  • Chronic disorder
  • Non-traumatic bone fractures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620763


Locations
United States, North Dakota
United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
Grand Forks, North Dakota, United States, 58202
Sponsors and Collaborators
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: Jay Cao, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jay Cao, Research Nutritionist, United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00620763     History of Changes
Other Study ID Numbers: GFHNRC087
IRB-2000707-013
First Submitted: January 18, 2008
First Posted: February 21, 2008
Results First Submitted: December 31, 2008
Results First Posted: August 3, 2009
Last Update Posted: August 10, 2011
Last Verified: August 2011

Keywords provided by USDA Grand Forks Human Nutrition Research Center:
Meat protein
acid load
calcium retention
postmenopausal women

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs


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