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Randomized Controlled Trial
. 2025 May 28;16(7):e00865.
doi: 10.14309/ctg.0000000000000865. eCollection 2025 Jul 1.

Effects of Ricinoleic Acid (Castor Oil) on Gut Permeability in Healthy Participants: Provocative Test for Treatments Aimed at Restoring Barrier Function

David Yi Yang  1 , Camille Lupianez-Merly  1 , Kara J Jencks  1 , Saam Dilmaghani  1 , Irene Busciglio  1 , Deborah Eckert  1 , Michael Ryks  1 , Roy Dyer  2 , Brady A Vizenor  2 , Yuxi Zhao  3 , Anna Sapone  3 , Michelle G Rooks  3 , Jeremy D Gale  3 , Michael Camilleri  1
Affiliations
Randomized Controlled Trial

Effects of Ricinoleic Acid (Castor Oil) on Gut Permeability in Healthy Participants: Provocative Test for Treatments Aimed at Restoring Barrier Function

David Yi Yang et al. Clin Transl Gastroenterol. .

Abstract

Introduction: Altered intestinal permeability (IP) is implicated in multiple gastrointestinal and systemic disease conditions; an experimental model of perturbed IP in healthy subjects is needed. Traditional approaches to perturbing IP include use of nonsteroidal anti-inflammatory drugs.

Methods: We conducted a single-center, randomized, placebo-controlled pilot study of dose-related effects of castor oil (CO) (and its ingredient ricinoleic acid) at 750, 1,500, or 3,000 mg daily doses on IP. Permeability was assessed using validated 13 C-mannitol and lactulose urine excretion at 0-2, 8-24, and 0-24 hours after oral administration.

Results: Permeability analysis across all groups demonstrated significant difference among the groups for 0-2 hours 13 C-mannitol, 0-24 hours 13 C-mannitol, and borderline significant difference for 2-8 hours 13 C-mannitol ( P = 0.060) and 0-24 hours lactulose ( P = 0.056). Direct comparison of 3,000 mg CO vs placebo ( t test) demonstrated higher excretion of 13 C-mannitol and lactulose at 0-2, and 0-24 hours, and lactulose at 2-8 hours.

Discussion: CO may perturb small intestinal and colonic permeability in healthy adults.

Keywords: castor oil; intestinal permeability; leaky gut.

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Conflict of interest statement

Guarantor of the article: Michael Camilleri accepts full responsibility for the conduct of the study. He had access to the data and has control of the decision to publish.

Specific author contributions: D.Y.Y.: patient recruitment, statistical analysis, drafting and editing manuscript. C.L.-M.: patient recruitment. K.J.: patient recruitment. S.D.: protocol creation. I.B.: research study coordinator. D.E.: research study coordinator. M.R.: research study coordinator. R.D.: laboratory sample analysis. B.A.V.: laboratory sample analysis. Y.Z.: statistical analysis, editing manuscript. A.S.: data interpretation, editing manuscript. M.R.: data interpretation, editing manuscript. J.G.: protocol creation, data interpretation, editing manuscript. M.C.: conceptualization and protocol creation, principal investigator, authorship.

Financial support: This research study was funded by Pfizer, Inc.

Potential competing interests: Y.Z., A.S., M.G.R., and J.D.G. are employees of Pfizer.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Urine excretion of 13C-mannitol at 0–2 and 0–24 hours showing significant increase in 13C-mannitol excretion in 3,000 mg castor oil group compared with placebo (unpaired t test).
See this image and copyright information in PMC

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