A Study of Perturbation of Human Small Intestinal Colonic Permeability

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Mayo Clinic

Status and phase

Enrolling
Early Phase 1

Conditions

Healthy

Treatments

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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