A Study of Perturbation of Human Small Intestinal Colonic Permeability

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

Official Title
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Developing an Approach to Perturbation of Human Small Intestinal and Colonic Permeability in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Ricinoleic Acid 750 mg
* Dietary Supplement: Ricinoleic Acid 1500 mg
* Dietary Supplement: Ricinoleic Acid 3000 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 750 mg castor oil treatment group<br>Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days | Dietary Supplement: Ricinoleic Acid 750 mg<br>* 750 mg administered orally<br>|
| Experimental: 1500 mg castor oil treatment group<br>Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days | Dietary Supplement: Ricinoleic Acid 1500 mg<br>* 1500 mg administered orally<br>|
| Experimental: 3000 mg castor oil treatment group<br>Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days | Dietary Supplement: Ricinoleic Acid 3000 mg<br>* 3000 mg administered orally<br>|
| Placebo Comparator: Placebo group<br>Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days | Drug: Placebo<br>* Contains no active ingredient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary excretion of 13^C-mannitol | Percent urinary excretion of 13^C-mannitol | 0-2 hours, 2-8 hours and 8-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary excretion of lactulose | Percent urinary excretion of lactulose | 0-2 hours, 2-8 hours and 8-24 hours |