NCT02758015

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

April 28, 2016

Last Update Submit

January 21, 2020

Conditions

Healthy

Keywords

betainebetaine hydrochloridehealthy volunteergastric pH

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 hours

Study Arms (4)

Standardized Meal

ACTIVE COMPARATOR

Standardized meal given to patients.

Other: Standardized Meal

Beatine PO (by mouth) 1500mg

EXPERIMENTAL

Betaine (natural supplement)

Other: Standardized MealDietary Supplement: Betaine Hydrochloride 1500mg

Betaine PO (by mouth) 3000mg

EXPERIMENTAL

Betaine (natural supplement)

Other: Standardized MealDietary Supplement: Betaine Hydrochloride 3000mg

Betaine PO (by mouth) 4500mg

EXPERIMENTAL

Betaine (natural supplement)

Other: Standardized MealDietary Supplement: Betaine Hydrochloride 4500mg

Interventions

Standardized MealOTHER
Beatine PO (by mouth) 1500mgBetaine PO (by mouth) 3000mgBetaine PO (by mouth) 4500mgStandardized Meal
Betaine Hydrochloride 1500mgDIETARY_SUPPLEMENT

Betaine hydrochloride (natural supplement) administered after standardized meal.

Beatine PO (by mouth) 1500mg
Betaine Hydrochloride 3000mgDIETARY_SUPPLEMENT

Betaine hydrochloride (natural supplement) administered after standardized meal.

Betaine PO (by mouth) 3000mg
Betaine Hydrochloride 4500mgDIETARY_SUPPLEMENT

Betaine hydrochloride (natural supplement) administered after standardized meal.

Betaine PO (by mouth) 4500mg

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, UCSF

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • 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.

    PMID: 31485804DERIVED

MeSH Terms

Interventions

Betaine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium Compounds

Study Officials

  • Leslie Z Benet, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Lynda A Frassetto, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 2, 2016

Study Start

June 1, 2016

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

US(1)