Effect of Betaine and Food on Gastric pH

Inclusion criteria

• Male or female 18-64 years of age;
• 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 - 32 kg/m2;
• Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
• 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 3pm 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 criteria

• 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 liver failure or LFTs >2x upper limit of normal;
• Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician;
• Subjects with Hct < 30 mg/dL, WBC < 2000/μL, ANC < 1000/μL, or platelet count < 150,000/μL;
• Subjects with a history or presence of an abnormal ECG, including demonstration of a baseline corrected Fridericia's QT interval (QTcF) >450ms, which in the opinion of the study physician, is clinically significant;
• Subjects who smoke tobacco;
• Subjects with ongoing alcohol or illegal drug use;
• Subjects who are pregnant, lactating or attempting to conceive;
• Subjects unable to follow protocol instructions or protocol criteria.
• Anyone who in the opinion of the study investigators is unable to participate in the study.