HealthyNCT00128804
The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients
A study testing absorption and conversion of beta-carotene in human gastrointestinal (GI) tract in people with Healthy and Ileostomy, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- What is being tested?
- absorption and conversion of beta-carotene in human gastrointestinal (GI) tract
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2004to Oct 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500HB
About this 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
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.
- Being tested
- absorption and conversion of beta-carotene in human gastrointestinal (GI) tract
- Keywords
- vitamin A, beta Carotene, diet, nutrition, nutritional requirements
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
absorption and conversion of beta-carotene in human gastrointestinal (GI) tractBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startJul 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Dairy Organization (NZO)
- Investigators
- Ton HJ Naber, MD PhD, Study director, Radboud University Medical CenterClive E West, PhD DSc, Principal investigator, Radboud University Medical CenterCarolien A Bouwman, MSc, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128804
- Sponsor's protocol ID
- STOVITA-2004-03-19-NZO
- Other IDs
- NZO-2002-07
- Status last verified
- Aug 2005
- First submitted
- 9 Aug 2005
- Last updated
- 29 Aug 2005
- Results posted
- No
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.
PubMed 11333850van 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.
PubMed 12499318Van 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.
PubMed 20132586
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00128804
- Acronym / sponsor ID
- STOVITA-2004-03-19-NZO
- Keywords
- vitamin A, beta Carotene, diet, nutrition, nutritional requirements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Dairy Organization (NZO)
- Study start
- Jul 2004
- Study completion
- Oct 2004
- First posted
- 10 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| absorption and conversion of beta-carotene in human gastrointestinal (GI) tract | Behavioural | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2005.
- Background: PubMed 11333850van 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.
- Background: PubMed 12499318van 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.
- Derived from this study: PubMed 20132586Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ton HJ Naber, MD PhD study director
Radboud University Medical Center
Clive E West, PhD DSc principal investigator
Radboud University Medical Center
Carolien A Bouwman, MSc study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing absorption and conversion of beta-carotene in human gastrointestinal (GI) tract in people with Healthy and Ileostomy, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00128804, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2005.