Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standardized Meal | Active Comparator | Standardized meal given to patients. |
|
| Beatine PO (by mouth) 1500mg | Experimental | Betaine (natural supplement) |
|
| Betaine PO (by mouth) 3000mg | Experimental | Betaine (natural supplement) |
|
| Betaine PO (by mouth) 4500mg | Experimental | Betaine (natural supplement) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardized Meal | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leslie Z Benet, PhD | University of California, San Francisco | Principal Investigator |
| Lynda A Frassetto, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, UCSF | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31485804 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001622 | Betaine |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Betaine Hydrochloride 1500mg | Dietary Supplement | Betaine hydrochloride (natural supplement) administered after standardized meal. |
|
| Betaine Hydrochloride 3000mg | Dietary Supplement | Betaine hydrochloride (natural supplement) administered after standardized meal. |
|
| Betaine Hydrochloride 4500mg | Dietary Supplement | Betaine hydrochloride (natural supplement) administered after standardized meal. |
|
| D009861 |
| Onium Compounds |