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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128804
• Other study ID #: STOVITA-2004-03-19-NZO
• Secondary ID: NZO-2002-07
• Status: Completed
• Phase: N/A
• First received: August 9, 2005
• Last updated: August 26, 2005
• Start date: July 2004
• Est. completion date: October 2004

Study information

• Verified date: August 2005
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Ileostomy

Intervention

Behavioral:
• absorption and conversion of beta-carotene in human gastrointestinal (GI) tract

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Dairy Organization (NZO)

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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