Effect of Betaine and Food on Gastric pH

January 21, 2020 updated by: University of California, San Francisco

Countering the Gastric ph Effect of a Standardized Meal in Healthy Volunteers Using Clinical Doses of Betaine Hydrochloride

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Clinical Research Center, UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standardized Meal
Standardized meal given to patients.
Other: Standardized Meal
Experimental: Beatine PO (by mouth) 1500mg
Betaine (natural supplement)
Other: Standardized Meal
Dietary supplement: Betaine Hydrochloride 1500mg
Betaine hydrochloride (natural supplement) administered after standardized meal.
Experimental: Betaine PO (by mouth) 3000mg
Betaine (natural supplement)
Other: Standardized Meal
Dietary supplement: Betaine Hydrochloride 3000mg
Betaine hydrochloride (natural supplement) administered after standardized meal.
Experimental: Betaine PO (by mouth) 4500mg
Betaine (natural supplement)
Other: Standardized Meal
Dietary supplement: Betaine Hydrochloride 4500mg
Betaine hydrochloride (natural supplement) administered after standardized meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Gastric pH After Administration of Standardized Meal
Time Frame: 15 minutes
After Heidelberg capsule is placed and baseline gastric levels have been recorded using the Heidelberg Capsule (HC), which sends real-time signals to a computer system that visually plots intestinal pH on a minute-by-minute basis, a standardized meal is given. Gastric pH is measured for 15 minutes after the administration of the meal.
15 minutes
Change in Gastric pH After Administration of Standardized Meal and Betaine hydrochloride
Time Frame: 3 hours
After 15 minutes of gastric pH monitoring following the standardized meal, betaine hydrochloride will be administered and its effect on the ability to mitigate that rise in gastric pH will be determined using the Heidelberg capsule over the span of approximately 3 hours. This will be done three separate times with 3 doses (1500mg, 3000mg, and 4500mg) dosed orally with 90ml of water.
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Leslie Z Benet, PhD, University of California, San Francisco
  • Principal Investigator: Lynda A Frassetto, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

March 26, 2018

Study Completion (Actual)

March 26, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-18635

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Standardized Meal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe