Study I: To assess the bioavailability of Zinc from full cream UHT milk, fortified full cream UHT milk, a supplement, and raw milk.Study II: To assess the potential enhancing effect of milk on Zn absorption from intrinsically labelled rice (as a…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
opname van micronutrienten in de darm
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fractional absorption of Zn, as measured from isotope ratios in urine samples.
Secondary outcome
Secondary parameters:
- Inflammation markers: C-reactive protein (CRP), α-glycoprotein (AGP) in blood
- Zn status in blood
- Food Frequency Questionnaire
Only at baseline:
- Body weight and height
Background summary
Zinc 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. There are indications in the literature
that milk could enhance Zn absorption from plant-based foods, but this needs to
be confirmed. To our knowledge, information on zinc absorption from regular
dairy products in human subjects is scarce, as well as information on the
effect of enhancing factors (proteins) in milk.
Study objective
Study I: To assess the bioavailability of Zinc from full cream UHT milk,
fortified full cream UHT milk, a supplement, and raw milk.
Study II: To assess the potential enhancing effect of milk on Zn absorption
from intrinsically labelled rice (as a model for a phytate containing staple
food)
Study design
Open, partially randomized, cross-over study.
Intervention
Study I: Intake of
1) Two times 400 ml full cream *Langlekker* milk, extrinsically labelled with 1
mg of 67Zn, consumed with a 1-hr interval;
2) Two times 200 ml Zn-fortified full cream *Langlekker* milk + 200 mL water
(to keep volume the same), extrinsically labeled with 1 mg of 67Zn , consumed
with a 1-hr interval;
3) Two times 400 ml water + Zn supplement, extrinsically labelled with 1 mg of
67Zn, consumed with a 1-hr interval.
4) Two times 400 ml raw milk
Study II: Intake of
1) Two times 45 g intrinsically 67Zn labelled rice + 300 mL of full cream
*Langlekker* milk , consumed with a 1-hr interval;
2) Two times 45 g intrinsically 67Zn labelled rice + 300 mL of Zn fortified
water, consumed with a 1-hr interval.
Each meal will contain ~ 4 mg of Zn. In between meals, subjects will receive an
intravenous dose of 0.2 mg 70Zn, dissolved in 10 mL saline.
Study burden and risks
The risks associated with participation can be considered minimal. The
intervention products and stable isotopes are safe for human use; apart from
possible gastrointestinal discomfort from consuming 800 mL of milk, and no side
effects are expected for the subjects (except rare complications of
venepuncture and intravenous injection such as bleeding and bruising). The
burden consists of 4 (study I) or 2 (study II) test days; on each test day the
subjects consume one of the test products, undergo a venepuncture and an
intravenous injection. Four days later subjects will collect a urine sample.
The subjects will not experience any health benefit from participation. Similar
studies on Zn bioavailability from intrinsically labelled rice and millet have
been performed in the past four years in a collaborative project between WU and
ETH Zürich at study sites in China, Switzerland and Burkina Faso. Therefore,
ample experience with these stable isotope studies is at hand.
Bronland 20
Wageningen 6708 WH
NL
Bronland 20
Wageningen 6708 WH
NL
Listed location countries
Age
Inclusion criteria
- Female
- Age: 18- 30 years of age
- Body Mass Index (BMI): 19-25 kg/m2 and body weight: 60-70 kg
- No mineral and vitamin supplements two weeks prior to the 1st test day 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/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/week
- Bad venous access
- Reported weight loss or gain of > 2kg in the last month before screening
- Reported strictly prescribed diet, vegan or macrobiotic
- Smoking
- Pregnant or lactating or the wish to become pregnant in the study period (a pregnancy test will be done before the last test day of Study I)
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL45256.081.13 |
OMON | NL-OMON21804 |