Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial.
Level 2 - randomized trial
Individual randomized crossover trial
PubMed 31485804 · doi:10.1007/s11095-019-2693-5
What was done
An open-label, 4-period crossover trial in 9 subjects randomly assigned to one of 16 sequences. The study assessed the effect of food on gastric pH and evaluated whether oral betaine hydrochloride (BHCl) at doses of 1500 mg, 3000 mg, and 4500 mg could accelerate gastric reacidification following food-induced pH elevation.
What was found
Mean maximum gastric pH following food ingestion was 3.20 ± 0.55. Without acid supplementation, the time required to return to baseline gastric pH after eating was 49.7 ± 14.0 minutes. Administration of 4500 mg BHCl capsules shortened the time to return to baseline pH to 17.3 ± 5.9 minutes. Area under the curve (AUC) for pH across treatments was similar and not statistically significantly different. Specific numeric values for the 1500 mg and 3000 mg doses were not reported in the abstract.
Why it matters
Food exerts a strong buffering effect on gastric pH that requires a high dose of supplemental acid (4500 mg BHCl) to overcome rapidly. This highlights the complexity of optimizing gastric pH for poorly soluble, weakly basic drugs when taken with food.
Limits
The study had an extremely small sample size (n = 9) and an open-label design. Drug absorption and clinical pharmacokinetic endpoints were not directly evaluated in the reported data, and the abstract omitted specific quantitative results for the intermediate BHCl doses.
Cited by
- partial Betaine hydrochloride acts as an effective remedy for intestinal gas, indigestion, and acid reflux by acidifying the stomach.