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Completed

NCT Number: NCT06033222

A Study of Perturbation of Human Small Intestinal Colonic Permeability

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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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ricinoleic Acid 750 mg

Dietary Supplement

750 mg administered orally

Ricinoleic Acid 1500 mg

Dietary Supplement

1500 mg administered orally

Ricinoleic Acid 3000 mg

Dietary Supplement

3000 mg administered orally

Placebo

Drug

Contains no active ingredient.

Primary outcomes

  1. Change in urinary excretion of 13^C-mannitol

    Time frame: 0-2 hours, 2-8 hours and 8-24 hours

    Percent urinary excretion of 13^C-mannitol

Secondary outcomes

  1. Change in urinary excretion of lactulose

    Time frame: 0-2 hours, 2-8 hours and 8-24 hours

    Percent urinary excretion of lactulose

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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