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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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