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van CCT (UK)

van CCT (UK)

Bioavailability of zinc from milk and rice using a stable isotope method

- candidate number15712
- NTR NumberNTR4267
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2013
- Secondary IDsNL45256.081.13 
- Public TitleBioavailability of zinc from milk and rice using a stable isotope method
- Scientific TitleBioavailability of zinc from milk and rice using a stable isotope method
- hypothesisStudy I: To assess the bioavailability of Zinc from milk (1), fortified milk (2), a supplement (3), and from raw milk (4).
Study II: To assess the effect of milk on Zn absorption from intrinsically labelled rice
- Healt Condition(s) or Problem(s) studiedBioavailability, Absorption
- Inclusion criteria Female
Age between 18-30 years of age (boundaries included)
Body Mass Index (BMI) between 19-25 kg/m2 (boundaries included)
Body weight between 60-70 kg (boundaries included)
No mineral and vitamin supplements two weeks prior to the 1st test meal and during the whole duration of the study
Willing to abstain from blood donation during the study
Voluntary participation
Signed informed consent
Willing to comply with the study procedures
- Exclusion criteria Any metabolic, gastrointestinal, inflammatory or chronic disease or disorder (such as diabetes, anaemia, hepatitis, hypertension, cancer or cardiovascular diseases; according to the subjects own statement)
Continuous/long-term medication during the whole study (except for contraceptives)
Mineral or vitamin supplements during the 2 weeks prior to 1st test meal
Lactose intolerance
Alcohol consumption > 21 glasses per week
Bad venous access
Reported weight loss or gain of > 2 kg in the last month before screening
Reported strictly prescribed diet, vegetarian, vegan or macrobiotic
Pregnant or lactating or the wish to become pregnant in the study period (a pregnancy test will be done at screening)
Lack of safe contraception
Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-jan-2014
- planned closingdate1-mei-2014
- Target number of participants38
- InterventionsStudy I:
Intake of
1. milk
2. Zn-fortified milk
3. water + Zn supplement
4. raw milk
All test meals are extrinsically labelled with 67Zn.

Study II:
Intake of
1. intrinsically 67Zn labelled rice + milk
2. intrinsically 67Zn labelled rice + Zn fortified water

Each meal will contain ~ 4 mg Zn. In between meals, subjects will receive an intravenous dose of 0.2 mg 70Zn, dissolved in 10 mL saline.
- Primary outcomeFractional absorption of Zn, as measured from isotope ratios in urine samples.
- Secondary outcome Zn status in blood
Inflammation markers(C-reactive protein (CRP) and -glycoprotein (AGP)) in blood.
- TimepointsAt all test days urine samples will be collected at baseline and at at 96 3 h after test meal administration.

At all test days blood samples will be collected at baseline.
- Trial web siteN/A
- statusplanned
- CONTACT for SCIENTIFIC QUERIESDr. Alida Melse-Boonstra
- Sponsor/Initiator Wageningen University, Division of Human Nutrition
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryZinc deficiency is widespread globally. Some estimates indicate that 20% of the total world population has some degree of zinc deficiency. Zinc is one of the many essential nutrients found in milk. With a concentration of ~0.4 mg Zn per 100 g of milk, it forms an important source of Zn in dairy consuming populations such as in the Netherlands. To our knowledge, information on zinc absorption from regular dairy products and dairy containing meals in human subjects is scarce.
- Main changes (audit trail)
- RECORD18-nov-2013 - 13-jan-2014

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