A Study of Perturbation of Human Small Intestinal Colonic Permeability

Early Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Dietary Supplement: Ricinoleic Acid 1500 mg; Drug: Placebo; Dietary Supplement: Ricinoleic Acid 750 mg; Dietary Supplement: Ricinoleic Acid 3000 mg

• Registration Number: NCT06033222
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this study is to evaluate the effect of castor oil versus placebo on intestinal permeability in healthy individuals.

Detailed Description

Randomized, parallel-group, placebo-controlled, blinded, dose-response study using Castor oil and see the effects it has on small bowel and colonic permeability measured in healthy female and male adults.

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Study Start: 2024-01-08
• Primary Completion: 2024-05-23
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-12
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy, non-obese, non-pregnant volunteers.
• 1:1 Male/Female Ratio.
• BMI < 30 kg/m^2.

Exclusion Criteria

• Diabetes.
• Uncontrolled hypertension (with BP measured > 140/90mmHg in the CRTU)
• BMI ≥ 30 kg/m^2.
• Chronic NSAID use (> 1 day/week).
• Use of oral antibiotics for 2 weeks prior to and during the entire 5 day study period.
• Known intolerance of castor oil.
• Diagnosis of gastrointestinal diseases that are associated with abnormal intestinal or colonic permeability such as inflammatory bowel diseases, irritable bowel syndrome and celiac disease.
• Prior intestinal or colonic resection.
• Participation in highly vigorous exercise such as running > 5 miles per day in week prior to the permeability test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1500 mg castor oil treatment group	Ricinoleic Acid 1500 mg	Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
Placebo group	Placebo	Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
750 mg castor oil treatment group	Ricinoleic Acid 750 mg	Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days
3000 mg castor oil treatment group	Ricinoleic Acid 3000 mg	Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days

Primary Outcome Measures

Name	Time	Method
Change in urinary excretion of 13^C-mannitol	0-2 hours, 2-8 hours and 8-24 hours	Percent urinary excretion of 13\^C-mannitol

Secondary Outcome Measures

Name	Time	Method
Change in urinary excretion of lactulose	0-2 hours, 2-8 hours and 8-24 hours	Percent urinary excretion of lactulose

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States