Tier 2 — strong

Food, Acid Supplementation and Drug Absorption - a Complicated Gastric Mix: a Randomized Control Trial

Dalga D Surofchy, Lynda A Frassetto, Leslie Z Benet
Pharmaceutical research 2019 36(11):155

Bibliography

PubMed
PMID 31485804
PubMed Central
PMC7484952
DOI
10.1007/s11095-019-2693-5
Funding
Indexed grant support: UL1 TR000004 — NCATS NIH HHS — United States. The indexed list may not contain the complete funding declaration.
Competing interests
Reported disclosure: s: None

Study snapshot

DesignRandomized open-label crossover RCT
ModelHuman participants
Sample9 healthy adults
InterventionBetaine HCl 1.5, 3 or 4.5 g after food
DurationFour acute treatment periods
EndpointsGastric pH; Meal effects; Dose response

What the study showed, in plain terms

Published in 2019, this source examined betaine hcl and topical formulations. Design: Randomized open-label crossover RCT. Sample/model: 9 healthy adults. The exposure or intervention was Betaine HCl 1.5, 3 or 4.5 g after food. Follow-up or treatment period: Four acute treatment periods.

The 4.5 g dose shortened the return to baseline stomach pH after food; overall pH exposure did not clearly differ across treatments.

Small acute pH study; it does not establish better digestion, symptom relief or long-term safety.

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Key findings

  • The 4.5 g dose shortened the return to baseline stomach pH after food; overall pH exposure did not clearly differ across treatments.
  • The recorded outcome domains were Gastric pH; Meal effects; Dose response.
  • The result applies to the tested exposure: Betaine HCl 1.5, 3 or 4.5 g after food; Four acute treatment periods.

What this study can and cannot tell us

  • Small acute pH study; it does not establish better digestion, symptom relief or long-term safety.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Accessible full-text extract plus indexed bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology