- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00128804
The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients
August 26, 2005 updated by: Radboud University Medical Center
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6500HB
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Ton HJ Naber, MD PhD, Radboud University Medical Center
- Principal Investigator: Clive E West, PhD DSc, Radboud University Medical Center
- Study Chair: Carolien A Bouwman, MSc, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1093/ajcn/73.5.949.
- 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. doi: 10.1093/ajcn/77.1.12.
- Van Loo-Bouwman CA, Naber TH, van Breemen RB, Zhu D, Dicke H, Siebelink E, Hulshof PJ, Russel FG, Schaafsma G, West CE. Vitamin A equivalency and apparent absorption of beta-carotene in ileostomy subjects using a dual-isotope dilution technique. Br J Nutr. 2010 Jun;103(12):1836-43. doi: 10.1017/S0007114509993849. Epub 2010 Feb 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Study Completion
October 1, 2004
Study Registration Dates
First Submitted
August 9, 2005
First Submitted That Met QC Criteria
August 9, 2005
First Posted (Estimate)
August 10, 2005
Study Record Updates
Last Update Posted (Estimate)
August 29, 2005
Last Update Submitted That Met QC Criteria
August 26, 2005
Last Verified
August 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STOVITA-2004-03-19-NZO
- NZO-2002-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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