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临床试验/NCT00719160
NCT00719160已完成4 期

Dietary Protein's Effect on Gastric pH and Calcium Absorption

Yale University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Percent Change in Intestinal Calcium Absorption

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy men and women age 18-45 years
  • Caucasian or Asian descent due to increased risk of Osteoporosis

排除标准

  • gastrointestinal diseases
  • osteoporosis
  • hypertension
  • liver disease
  • thyroid disorders
  • kidney disease
  • kidney stones
  • heart disease
  • eating disorders
  • hypogonadism
  • amenorrhea
  • oligomenorrhea
  • abnormal serum FSH or estradiol levels
  • birth control medication or other hormone-altering medications
  • pregnancy
  • Lifestyle factors such as:
  • 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

研究组 & 干预措施

Esomeprazole

Placebo Comparator

干预措施: esomeprazole (Drug)

Esomeprazole

Placebo Comparator

干预措施: Placebo (Drug)

Placebo

Active Comparator

干预措施: esomeprazole (Drug)

Placebo

Active Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Percent Change in Intestinal Calcium Absorption

时间窗: Day 5 of a high protein diet

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.

次要结局

  • Gastric pH(Day 5 of a high protein diet)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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