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


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Ileostomy, Colostomy, and Ileoanal Reservoir Surgery


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

This study has been completed.

Sponsors and Collaborators: Radboud University
Dutch Dairy Association
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00128804

Purpose

A controlled dietary intervention study will be carried out based on the stable isotope method we have developed to quantify both the absorption of beta-carotene and its bioconversion to retinol in oil and in mixed diet. During 4 weeks the participants will consume 2 capsules/d, 7 d/wk with each capsule containing 100-mg [13C10]beta-carotene and 100-mg [13C10]retinyl palmitate. Two weeks they will consume a diet with high levels of beta-carotene in the vegetables and fruits and the other 2 weeks they will consume a diet with low levels of beta-carotene in the vegetables and fruits supplemented with 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 mixed diet differs a factor 3 to 6. We want to measure the influence of the food matrix of vegetables and fruits on the absorption of beta-carotene in ileostomy patients in a western diet.
Condition Intervention
Health
Ileostomy
 Behavior: absorption and conversion of beta-carotene in human GI tract

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-availability Study

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

Further Study Details: 
Primary Outcomes: levels of retinol and carotenoids and the degree of isotopic enrichment in serum (fasting blood sample) and in faeces (72 h collection) at the start and at the end of the each of the 2-week periods
Expected Total Enrollment:  18

Study start: July 2004;  Study completion: August 2005
Last follow-up: October 2004;  Data entry closure: November 2004

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

  • men and women between 18 and 75 years old
  • BMI between 18 and 30 kg/m2
  • willing to consume the controlled diet and not consuming other food items
  • willing to consume the capsules every day
  • having an functional ileostomy (output <2 L/d)
  • relative 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 wk before and during the study
  • not too low or high serum beta-carotene and retinol
  • normal hemoglobin, hemocytometry, creatinine, ALAT, alkalic phosphatase, cholesterol blood values (compared with laboratory references)
  • pregnancy

Location Information


Netherlands, Gelderland
      Radboud University Nijmegen Medical Centre, Nijmegen,  Gelderland,  6500HB,  Netherlands

Study chairs or principal investigators

Ton HJ Naber, MD PhD,  Study Director,  Radboud University   
Clive E West, PhD DSc,  Principal Investigator,  Radboud University   
Carolien A Bouwman, MSc,  Study Chair,  Radboud University   

More Information

Publications

van Lieshout M, West CE, Muhilal, Permaesih D, Wang Y, Xu X, van Breemen RB, Creemers AF, Verhoeven MA, Lugtenburg J. Bioefficacy of beta-carotene dissolved in oil studied in children in Indonesia. Am J Clin Nutr. 2001 May;73(5):949-58.

van Lieshout M, West CE, van Breemen RB. Isotopic tracer techniques for studying the bioavailability and bioefficacy of dietary carotenoids, particularly beta-carotene, in humans: a review. Am J Clin Nutr. 2003 Jan;77(1):12-28. Review.

Study ID Numbers:  STOVITA-2004-03-19-NZO; NZO-2002-07
Last Updated:  August 9, 2005
Record first received:  August 9, 2005
ClinicalTrials.gov Identifier:  NCT00128804
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-08-23


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October 6, 2008



Page Updated: September 6, 2005
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