HealthyNCT02758015

Effect of Betaine and Food on Gastric pH

A study testing Standardized Meal, Betaine Hydrochloride 1500mg and Betaine Hydrochloride 3000mg in people with Healthy, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Standardized Meal, Betaine Hydrochloride 1500mg and Betaine Hydrochloride 3000mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Jun 2016to 26 Mar 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Center, UCSF
San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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.

Conditions: Healthy
Being tested: Standardized Meal, Betaine Hydrochloride 1500mg, Betaine Hydrochloride 3000mg, Betaine Hydrochloride 4500mg
Keywords: betaine, betaine hydrochloride, healthy volunteer, gastric pH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standardized MealOther
Betaine Hydrochloride 1500mgDietary supplement
Betaine hydrochloride (natural supplement) administered after standardized meal.
Betaine Hydrochloride 3000mgDietary supplement
Betaine hydrochloride (natural supplement) administered after standardized meal.
Betaine Hydrochloride 4500mgDietary supplement
Betaine hydrochloride (natural supplement) administered after standardized meal.

Study groups in NCT02758015
Study group	Role	What they receive
Standardized Meal	Active comparator	Standardized meal given to patients. Receives: Other: Standardized Meal
Beatine PO (by mouth) 1500mg	Experimental	Betaine (natural supplement) Receives: Other: Standardized Meal; Dietary Supplement: Betaine Hydrochloride 1500mg
Betaine PO (by mouth) 3000mg	Experimental	Betaine (natural supplement) Receives: Other: Standardized Meal; Dietary Supplement: Betaine Hydrochloride 3000mg
Betaine PO (by mouth) 4500mg	Experimental	Betaine (natural supplement) Receives: Other: Standardized Meal; Dietary Supplement: Betaine Hydrochloride 4500mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Gastric pH After Administration of Standardized Meal
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.
Measured: 15 minutes
Change in Gastric pH After Administration of Standardized Meal and Betaine hydrochloride
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.
Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 201626 Mar 2018

First posted2 May 2016 (estimated)
Study startJun 2016
Primary completion26 Mar 2018
Study completion26 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02758015
Sponsor's protocol ID: 16-18635
Status last verified: Jan 2020
First submitted: 28 Apr 2016
Last updated: 23 Jan 2020
Results posted: No
Data monitoring committee: Yes

Publications

Surofchy DD, Frassetto LA, Benet LZ. Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial. Pharm Res. 2019 Sep 4;36(11):155. doi: 10.1007/s11095-019-2693-5.
PubMed 31485804

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Countering the Gastric ph Effect of a Standardized Meal in Healthy Volunteers Using Clinical Doses of Betaine Hydrochloride
ClinicalTrials.gov ID: NCT02758015
Acronym / sponsor ID: 16-18635
Conditions: Healthy
Keywords: betaine, betaine hydrochloride, healthy volunteer, gastric pH
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: Jun 2016
Primary completion: 26 Mar 2018 (actual)
Study completion: 26 Mar 2018 (actual)
First posted: 2 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Standardized Meal	Active comparator	Other: Standardized MealStandardized meal given to patients.
Beatine PO (by mouth) 1500mg	Experimental	Other: Standardized Meal, Dietary Supplement: Betaine Hydrochloride 1500mgBetaine (natural supplement)
Betaine PO (by mouth) 3000mg	Experimental	Other: Standardized Meal, Dietary Supplement: Betaine Hydrochloride 3000mgBetaine (natural supplement)
Betaine PO (by mouth) 4500mg	Experimental	Other: Standardized Meal, Dietary Supplement: Betaine Hydrochloride 4500mgBetaine (natural supplement)

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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;

Key exclusion criteria (13 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standardized Meal	Other	Beatine PO (by mouth) 1500mg, Betaine PO (by mouth) 3000mg, Betaine PO (by mouth) 4500mg, Standardized Meal
Betaine Hydrochloride 1500mgBetaine hydrochloride (natural supplement) administered after standardized meal.	Dietary supplement	Beatine PO (by mouth) 1500mg
Betaine Hydrochloride 3000mgBetaine hydrochloride (natural supplement) administered after standardized meal.	Dietary supplement	Betaine PO (by mouth) 3000mg
Betaine Hydrochloride 4500mgBetaine hydrochloride (natural supplement) administered after standardized meal.	Dietary supplement	Betaine PO (by mouth) 4500mg

Primary outcome

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.
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Derived from this study: PubMed 31485804Surofchy DD, Frassetto LA, Benet LZ. Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial. Pharm Res. 2019 Sep 4;36(11):155. doi: 10.1007/s11095-019-2693-5.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
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Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Colon-delivered Riboflavin and Gut Microbiota Composition
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie Z Benet, PhD principal investigator

University of California, San Francisco

Lynda A Frassetto, MD principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Standardized Meal, Betaine Hydrochloride 1500mg and Betaine Hydrochloride 3000mg in people with Healthy, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gastric pH After Administration of Standardized Meal (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758015, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.