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Calcium Retention as Influenced by Dietary Components That Induce an Acid Load
This study has been completed.
First Received: January 18, 2008   Last Updated: September 16, 2008   History of Changes
Sponsored by: USDA Grand Forks Human Nutrition Research Center
Information provided by: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00620763
  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: Controlled diet

MedlinePlus related topics: Calcium Diets
Drug Information available for: Calcium gluconate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Bio-availability Study
Official Title: Calcium Retention in Postmenopausal Women as Influenced by Beef and Other Dietary Components That Induce an Acid Load

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

Primary Outcome Measures:
  • Calcium-47 retention will be measured by whole body scintillation counting for 4 weeks after ingestion of the radio-labeled meals. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects of a high protein and high acid load diet on markers of bone metabolism and renal acid load [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

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
A: Experimental
Dietary Intervention: High meat and high acid load diet followed by low meat and low acid load diet
Other: Controlled diet
High meat and high acid load diet followed by low meat and low acid load diet
B: Experimental
Dietary Intervention: Low meat and low acid load diet followed by high meat and high acid load diet
Other: Controlled diet
Low meat and low acid load diet followed by high meat and high acid load diet.

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620763

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

Additional Information:
Publications:
Responsible Party: USDA Grand Forks Human Nutrition Research Center ( Jay Cao, Research Nutritionist )
Study ID Numbers: GFHNRC087, IRB-2000707-013
Study First Received: January 18, 2008
Last Updated: September 16, 2008
ClinicalTrials.gov Identifier: NCT00620763     History of Changes
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

Study placed in the following topic categories:
Calcium, Dietary
Healthy
Urinary Retention

ClinicalTrials.gov processed this record on May 06, 2009