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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00128804

Enrollment

Registered

2005-08-10

Start date

2004-07-31

Completion date

2004-10-31

Last updated

2005-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Ileostomy

Keywords

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

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026