The Effect of Protein on Calcium Absorption and Gastric Acid Production
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
esomeprazole
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Gastric acid, Dietary protein, Calcium, Intestinal absorption, Calcium sensing receptor
Eligibility Criteria
Inclusion Criteria:
- Healthy men and women age 18-45 years
- Caucasian or Asian descent due to increased risk of Osteoporosis
Exclusion Criteria:
- gastrointestinal diseases
- osteoporosis
- diabetes
- hypertension
- liver disease
- thyroid disorders
- kidney disease
- kidney stones
- cancer
- heart disease
- eating disorders
- obesity
- hypogonadism
- amenorrhea
- oligomenorrhea
- abnormal serum FSH or estradiol levels
- birth control medication or other hormone-altering medications
- pregnancy
Lifestyle factors such as:
- smoking
- excessive exercise (although moderate exercise is allowed)
- prescription medications known to influence vitamin D or calcium metabolism or gastric acid
- excessive body weight change during the past 6 months
- food allergies
- unusual eating habits or medically prescribed diets
Sites / Locations
- Yale New Haven Hospital Hospital Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Esomeprazole
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percent Change in Intestinal Calcium Absorption
This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.
Secondary Outcome Measures
Gastric pH
The American Heritage Dictionary defines pH as "a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14." The normal pH range for stomach acid is between 1.5 and 3.5.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00719160
Brief Title
The Effect of Protein on Calcium Absorption and Gastric Acid Production
Official Title
Dietary Protein's Effect on Gastric pH and Calcium Absorption
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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 (PPI) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Gastric acid, Dietary protein, Calcium, Intestinal absorption, Calcium sensing receptor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole
Arm Type
Placebo Comparator
Arm Title
Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Description
2 Interventions with esomeprazole 20 mg twice a day for 9 days vs. a placebo for 9 days while on a high protein diet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 20 mg twice a day for 9 days
Primary Outcome Measure Information:
Title
Percent Change in Intestinal Calcium Absorption
Description
This is completed by measuring the amount of calcium absorbed by utilizing dual stable calcium isotopes. It was hypothesized that we would see a percent decrease as a result of the proton pump inhibitor. Previous published data indicated a decline in calcium absorption of 6.6 +/- 5.5% when gastric pH is blocked.
Time Frame
Day 5 of a high protein diet
Secondary Outcome Measure Information:
Title
Gastric pH
Description
The American Heritage Dictionary defines pH as "a measure of the acidity or alkalinity of a solution, numerically equal to 7 for neutral solutions, increasing with increasing alkalinity and decreasing with increasing acidity. The pH scale commonly in use ranges from 0 to 14." The normal pH range for stomach acid is between 1.5 and 3.5.
Time Frame
Day 5 of a high protein diet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men and women age 18-45 years
Caucasian or Asian descent due to increased risk of Osteoporosis
Exclusion Criteria:
gastrointestinal diseases
osteoporosis
diabetes
hypertension
liver disease
thyroid disorders
kidney disease
kidney stones
cancer
heart disease
eating disorders
obesity
hypogonadism
amenorrhea
oligomenorrhea
abnormal serum FSH or estradiol levels
birth control medication or other hormone-altering medications
pregnancy
Lifestyle factors such as:
smoking
excessive exercise (although moderate exercise is allowed)
prescription medications known to influence vitamin D or calcium metabolism or gastric acid
excessive body weight change during the past 6 months
food allergies
unusual eating habits or medically prescribed diets
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Insogna, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital Hospital Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
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The Effect of Protein on Calcium Absorption and Gastric Acid Production
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