A Study of Perturbation of Human Small Intestinal Colonic Permeability

Mayo Clinic

Status and phase: Enrolling; Early Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Dietary Supplement: Ricinoleic Acid 3000 mg; Dietary Supplement: Ricinoleic Acid 750 mg; Dietary Supplement: Ricinoleic Acid 1500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06033222

23-003520

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

750 mg castor oil treatment group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ricinoleic Acid 750 mg

1500 mg castor oil treatment group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ricinoleic Acid 1500 mg

3000 mg castor oil treatment group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Ricinoleic Acid 3000 mg

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo