Method development to study the bioequivalence of provitamin A: a pilot study in Dutch adults aged 18-35 years.

Completed

Conditions: vitamine A deficientie
Vitamin A deficiency

Registration Number: NL-OMON49957

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Female
Dutch spoken
Age: 18-35 years
BMI: 18.5-25 kg/m2
Non-smoking

Exclusion Criteria

Pregnant or lactating
Metabolic disease (e.g. Diabetes Mellitus, hypercholesterolemia)
Disorder or use of drugs that interferes with fat-soluble vitamin absorption
History of chronic diseases (e.g. cancer, renal disease, liver disease,
gastrointestinal disorders)
Food allergies related to food that will be provided during the study
Recent (past 6 months) surgery, blood transfusion and blood donation
Dieting or having irregular dietary habits
Use of (multi)vitamin preparations with vitamin A or beta-carotene (< 3 months
before the study)
Participation in another clinical trial
Being an MSc student or employed at the Divsion of Human Nutrition and Health,
WUR

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of 13C10-labelled retinol in plasma with intakes of varying doses of<br /><br>unlabelled retinol over time (4 weeks), and the shape of the dose response<br /><br>curve. In addition, we will measure the area under the curve (AUC) of<br /><br>13C10-labelled *-carotene and 13C5-labelled retinol in blood plasma over a 24h<br /><br>period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Serum retinol concentration (µmol / L)<br /><br>- *-carotene bioconversion (%)<br /><br>- Inflammatory markers (C-reactive protein (CRP), alpha-glycoprotein (AGP)<br /><br>- Dietary energy and vitamin A intake<br /><br>- Genetic variants in the bco1 gene</p><br>