Calcium Retention as Influenced by Dietary Components That Induce an Acid Load
This study has been completed.
Sponsor:
USDA Beltsville Human Nutrition Research Center
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
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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:
MedlinePlus related topics:
Calcium
Drug Information available for:
Calcium Gluconate
U.S. FDA Resources
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
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:
Related Info 
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 |
Additional relevant MeSH terms:
|
Urinary Retention Urination Disorders Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013