A Study of Perturbation of Human Small Intestinal Colonic Permeability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-08

Study Completion Date

2024-07-31

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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized, placebo-control study of effect of castor oil on intestinal and colonic permeability

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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750 mg castor oil treatment group

Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days

Group Type EXPERIMENTAL

Ricinoleic Acid 750 mg

Intervention Type DIETARY_SUPPLEMENT

750 mg administered orally

1500 mg castor oil treatment group

Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days

Group Type EXPERIMENTAL

Ricinoleic Acid 1500 mg

Intervention Type DIETARY_SUPPLEMENT

1500 mg administered orally

3000 mg castor oil treatment group

Subjects will take ricinoleic acid daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days

Group Type EXPERIMENTAL

Ricinoleic Acid 3000 mg

Intervention Type DIETARY_SUPPLEMENT

3000 mg administered orally

Placebo group

Subjects will take placebo daily on an empty stomach in the morning 30 minutes before breakfast for a total of 4 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Contains no active ingredient.

Interventions

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Ricinoleic Acid 750 mg

750 mg administered orally

Intervention Type DIETARY_SUPPLEMENT

Ricinoleic Acid 1500 mg

1500 mg administered orally

Intervention Type DIETARY_SUPPLEMENT

Ricinoleic Acid 3000 mg

3000 mg administered orally

Intervention Type DIETARY_SUPPLEMENT

Placebo

Contains no active ingredient.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes