The CARO Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Healthy Subjects - Full Text View

Sponsors and Collaborators:	Radboud University Dutch Dairy Association
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00128752

Purpose

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 6 weeks the participants will consume 2 capsules/day, 7 days/week with each capsule containing 50-mg [13C10] beta-carotene and 50-mg [13C10] retinyl palmitate. For three weeks they will consume a diet with high levels of beta-carotene in vegetables and fruits and for the other 3 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 healthy humans on a western diet.

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

Drug Information available for: Vitamin A Retinol Carotenoids beta Carotene

U.S. FDA Resources

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 Healthy Subjects Measured Using Specifically 13C-Labelled Beta-Carotene and Retinol

Further study details as provided by Radboud University:

Primary Outcome Measures:

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 3-week periods

Estimated Enrollment:	24
Study Start Date:	March 2003
Estimated Study Completion Date:	October 2003

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Men and women between 18 and 50 years old
Body mass index (BMI) between 18 and 25 kg/m2
Willing to consume the controlled diet and not consume other food items
Willing to consume the cooked meal at the research facility and the bread meals and snacks at home (distributed to the participants)
Willing to consume the capsules every day

Exclusion Criteria:

Hematological diseases and chronic diseases including cancer, renal insufficiency, liver disease, diagnosed gastrointestinal disorders, or surgery of the gastrointestinal tract
Use of (oral) drugs suspected of interfering with fat-soluble-vitamin absorption
Smoking
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128752

Locations

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

Sponsors and Collaborators

Radboud University

Dutch Dairy Association

Investigators

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

West CE, Eilander A, van Lieshout M. Consequences of revised estimates of carotenoid bioefficacy for dietary control of vitamin A deficiency in developing countries. J Nutr. 2002 Sep;132(9 Suppl):2920S-2926S.

Study ID Numbers:	CARO-2002-12-12-NZO, NZO-2002-07
Study First Received:	August 9, 2005
Last Updated:	August 26, 2005
ClinicalTrials.gov Identifier:	NCT00128752
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

vitamin A
beta Carotene
diet
nutrition
nutritional requirements

Study placed in the following topic categories:

Beta Carotene
Retinol palmitate
Vitamin A
Healthy
Carotenoids

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins

Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009