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The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients

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ClinicalTrials.gov Identifier: NCT00128804
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : August 29, 2005
Dutch Dairy Organization (NZO)
Information provided by:
Radboud University

Brief Summary:
A controlled dietary intervention study will be carried out based on the stable isotope method the investigators have developed to quantify both the absorption of beta-carotene and its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will consume 2 capsules/day, 7 days/week with each capsule containing 100-mg [13C10] beta-carotene and 100-mg [13C10] retinyl palmitate. For two weeks they will consume a diet with high levels of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is that the absorption of beta-carotene in oil in comparison with the absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to measure the influence of the food matrix of vegetables and fruits on the absorption of beta-carotene in ileostomy patients on a western diet.

Condition or disease Intervention/treatment
Healthy Ileostomy Behavioral: absorption and conversion of beta-carotene in human gastrointestinal (GI) tract

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bioefficacy and Bioavailability of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients Measuring Using Specifically 13C-Labelled Beta-Carotene and Retinol
Study Start Date : July 2004
Estimated Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Primary Outcome Measures :
  1. levels of retinol and carotenoids and the degree of isotopic enrichment in serum (fasting blood sample) and in faeces (72 hour collection) at the start and at the end of each of the 2-week periods

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women between 18 and 75 years old
  • Body mass index (BMI) between 18 and 30 kg/m2
  • Willing to consume the controlled diet and not consume other food items
  • Willing to consume the capsules every day
  • Having a functional ileostomy (output <2 L/d)
  • Relatively good medical, nutritional and health status

Exclusion Criteria:

  • Diseases which disturb normal digestion and absorption
  • Use of (oral) drugs suspected of interfering with fat-soluble vitamin absorption
  • Excessive alcohol consumption (>30 g/d)
  • Consumption of vitamin or carotenoid supplements 6 weeks before and during the study
  • Not too low or high levels of serum beta-carotene and retinol
  • Normal hemoglobin, hemocytometry, creatinine, ALAT, alkaline phosphatase, and cholesterol blood values (compared with laboratory references)
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128804

Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Dutch Dairy Organization (NZO)
Study Director: Ton HJ Naber, MD PhD Radboud University
Principal Investigator: Clive E West, PhD DSc Radboud University
Study Chair: Carolien A Bouwman, MSc Radboud University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00128804     History of Changes
Other Study ID Numbers: STOVITA-2004-03-19-NZO
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: August 29, 2005
Last Verified: August 2005

Keywords provided by Radboud University:
vitamin A
beta Carotene
nutritional requirements

Additional relevant MeSH terms:
Beta Carotene
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances