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

R

Radboud University Medical Center

Status

Completed

Conditions

Healthy
Ileostomy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00128804
NZO-2002-07
STOVITA-2004-03-19-NZO

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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