Phase 4 N=12 Randomized Triple-blind Treatment

The Effect of Protein on Calcium Absorption and Gastric Acid Production

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT00719160 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcome: Primary: Percent Change in Intestinal Calcium Absorption — 34.2; 31.5 percentage of calcium absorption

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: esomeprazole (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Intestinal Calcium Absorption	34.2; 31.5	—
SECONDARY Gastric pH	5.38; 2.70	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00719160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.