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

NCT ID: NCT00128804

Last Updated: 2005-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2004-10-31

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.

Conditions

Healthy; Ileostomy

Keywords

vitamin A; beta Carotene; diet; nutrition; nutritional requirements

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dutch Dairy Organization (NZO)

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Ton HJ Naber, MD PhD

Role: STUDY_DIRECTOR

Radboud University Medical Center

Clive E West, PhD DSc

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Carolien A Bouwman, MSc

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 11333850 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12499318 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20132586 (View on PubMed)

Other Identifiers

NZO-2002-07

Identifier Type: -

Identifier Source: secondary_id

STOVITA-2004-03-19-NZO

Identifier Type: -

Identifier Source: org_study_id