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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 17, 2008
Last Updated
March 4, 2020
Sponsor
Yale University
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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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