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Sponsored by: |
Yale University |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00719160 |
We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption.
Condition | Intervention | Phase |
---|---|---|
Osteoporosis |
Drug: esomeprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Dietary Protein's Effect on Gastric pH and Calcium Absorption |
Enrollment: | 12 |
Study Start Date: | January 2005 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
We have established that dietary protein is an important regulator of intestinal calcium absorption in humans. However, we do not understand the mechanism by which dietary protein is affecting calcium absorption. Therefore, the purpose of this research is to evaluate whether dietary protein-induced changes in gastric acid secretion explain the observed changes in intestinal calcium absorption. We have compelling in vitro data that amino acids can stimulate gastric acid secretion. We have found that this occurs via allosteric activation of the calcium sensing receptor expressed on the gastric acid-secreting parietal cells. At a fixed concentration of extracellular calcium, addition of L but not D isomers of specific amino acids activates the calcium sensing receptor and stimulates parietal cell acid production. We hypothesize that dietary protein induced gastric acid production increases calcium solubility and bioavailability thereby increasing its absorption. We will test this hypothesis in humans by quantifying the impact of dietary protein on intestinal calcium absorption in subjects who cannot make gastric acid. We will measure intestinal calcium absorption in healthy adults as they consume either a high protein diet with concomitant administration of a proton pump inhibiting drug or the same high protein diet with a placebo instead of a PPI. The order of the 2 interventions will be randomized, and study will be double-blind and placebo controlled. If our hypothesis is correct, then intestinal calcium absorption will be highest during the high protein diet with placebo, and lowest during the drug intervention.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Lifestyle factors such as:
United States, Connecticut | |
Yale New Haven Hospital Hospital Research Unit | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Karl Insogna, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Karl Insogna, MD ) |
Study ID Numbers: | 0408026977 |
Study First Received: | July 17, 2008 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00719160 |
Health Authority: | United States: Institutional Review Board |
Gastric acid Dietary protein Calcium Intestinal absorption Calcium sensing receptor |
Calcium, Dietary Musculoskeletal Diseases Omeprazole |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |