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

This study has been completed.
Sponsor:
Information provided by:
USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00620763
First received: January 18, 2008
Last updated: August 4, 2011
Last verified: August 2011
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years to 75 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Jay Cao, PhD USDA Grand Forks Human Nutrition Research Center
  More Information

Additional Information:
Publications:
Additional 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
Study First Received: January 18, 2008
Results First Received: December 31, 2008
Last Updated: August 4, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014