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Effect of Betaine and Food on Gastric pH

NCT02758015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-01-23

No results posted yet for this study

Summary

Food will decrease stomach acidity due to its buffering effect.This has implications when providing drugs that are dosed with food but require higher levels of stomach acid, such as some medications commonly used for HIV patients. This study will attempt to determine the dose of betaine hydrochloride (over the counter acid supplement) at which the effect of food on stomach acid could be countered. Additionally, this study will evaluate the ability of a natural supplement (betaine hydrochloride) to affect the gastric pH following a standardized meal in healthy volunteers. The investigators predict that 4500mg of betaine hydrochloride will have the greatest effect on gastric pH.

Conditions

  • Healthy

Interventions

OTHER

Standardized Meal

DIETARY_SUPPLEMENT

Betaine Hydrochloride 1500mg

Betaine hydrochloride (natural supplement) administered after standardized meal.

DIETARY_SUPPLEMENT

Betaine Hydrochloride 3000mg

Betaine hydrochloride (natural supplement) administered after standardized meal.

DIETARY_SUPPLEMENT

Betaine Hydrochloride 4500mg

Betaine hydrochloride (natural supplement) administered after standardized meal.

Sponsors & Collaborators

Principal Investigators

  • Leslie Z Benet, PhD · University of California, San Francisco

  • Lynda A Frassetto, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-03-26
Completion
2018-03-26

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758015 on ClinicalTrials.gov