Status:
COMPLETED
Study of the Ability of Betaine Hydrochloride to Increase Stomach Acid in Healthy Volunteers
Lead Sponsor:
University of California, San Francisco
Conditions:
Pharmacodynamic
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
In this study the investigators will test a nutritional supplement called betaine hydrochloride to see if it can temporarily increase the stomach acid in healthy volunteers who have decreased stomach ...
Detailed Description
Investigators will evaluate the extent and time course of gastric re-acidification after oral betaine HCl in healthy volunteers with pharmacologically-induced hypochlorhydria. After betaine HCl dose, ...
Eligibility Criteria
Inclusion
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam;
- BMI between 18.5 - 35 kg/m2;
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
- Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
- Be able to provide written informed consent and comply with requirements of the study;
- Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
- Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
- Fast from food and beverages at least 8 hours prior to the study day;
- Be able to read, speak and understand English
Exclusion
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia.
- Subjects with a fasting gastric pH of \> 4 (i.e. hypochlorhydria)
- Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills.
- Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
- Subjects with known allergy to study interventions;
- Subjects who smoke tobacco;
- Subjects with ongoing alcohol or illegal drug use;
- Subjects who are pregnant, lactating or attempting to conceive;
- Subjects unable to maintain adequate birth control during the study;
- Subjects unable to follow protocol instructions or protocol criteria.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01237353
Start Date
March 1 2011
End Date
July 1 2011
Last Update
July 2 2013
Active Locations (1)
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1
University of California San Francisco
San Francisco, California, United States, 94143