To determine the efficacy of a local vitamin-C rich fruits in improving iron absorption from multiple mungbean based meals in Dutch women aged between 18-40 years.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
mineralen absorptie aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the incorporation of 57Fe related to 58Fe into erythrocytes 14 d
after administration and calculated based on isotope-dilution.
Secondary outcome
Whole blood will be collected at recruitment for the analysis of Hb, Hb type,
serum ferritin (SF), transferrin receptor (TfR), C-reactive protein (CRP),
erythropoietin (Epo), serum iron (SI), total iron binding capacity (TIBC), and
transferrin saturation (TfSat). Anemia will be defined as a hemoglobin
concentration < 120 g/L, and iron deficiency will be defined as an SF
concentration < 12 µg/L.
Background summary
Iron deficiency (ID) and iron deficiency anemia (IDA) are the most prevalent
micronutrient deficiencies among women and children in India. Anemia is
associated with unfavourable birth outcomes in pregnant women and delayed or
retarded cognitive and psychomotor development in children younger than 2 years
of age. Non-heme iron constitute 91% of the total iron present in the Indian
diet, and pulses are a significant dietary protein source. Fruits, green leafy
vegetables, and animal products are infrequently consumed resulting in low
iron, zinc and vitamin A intake. Mungbean (Vigna radiata L.) is the third most
important pulse crop of India; it is a fairly good source of carbohydrates,
proteins, minerals e.g. calcium, iron and zinc. Several inhibitors in plant
based diets limit iron bioavailability; these include phytic acid and
polyphenols. Ascorbic acid is an important enhancer of iron absorption and has
been shown to enhance non-heme iron absorption in humans.
Study objective
To determine the efficacy of a local vitamin-C rich fruits in improving iron
absorption from multiple mungbean based meals in Dutch women aged between 18-40
years.
Study design
A stable-isotope study involving the incorporation of 57Fe and 58Fe iron
isotopes into erythrocytes following consumption of labelled test meals and
the determination of the isotopes concentrations 14 days post administration.
Intervention
Mungbean based test meals with labelled stable isotope solution, with or
without a guava meal.
Study burden and risks
Participants will be invited for 3 blood samples will be collected from each
subject within 31 days. The first sample will be taken on the first day of the
intervention, the second after 14 days and the last sample on day 31 of the
intervention. Subjects will consume 6 test meals within the first three days of
the intervention. Consumption of mungbean meals and consumption of guava may
prove unfamiliar because they have different flavours and textures than the
subjects may be used to. Written informed consent will be obtained from all
subjects. Participants will also have a medical questionnaire administered
during the screening period. Venapuncture could cause local inflammation and
little blood loss, however, this will be prevented by working with a qualified
and experienced research nurse. .
Postbus 8129
6700 EV Wageningen
Nederland
Postbus 8129
6700 EV Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
Age 18-40 years
Body weight < 65 kg;
Non pregnant, non lactating and not planning to become pregnant
Apparetly healthy, free of chronic illnesses and not taking chronic medication.
No medication nor supplemental iron at time of entry into the study.
No intake of vitamin and mineral supplements in the last 2 weeks prior the study, or willigness to discontinue.
Subject has not made blood donation in the last 6 months
Subjects that in the past did not participate in studies with administration of stable isotope labels in the past (iron).
Exclusion criteria
Younger than 18 years of age and older than 40 years of age
Post menopausal
Using medicinal iron or related preparations
Body weight > 65kg
Pregnant or lactating
People consuming chronic medication
Use of vitamin and mineral supplements
Blood donation in the last 6 months
Subjects that in the past participated in studies with administration of stable isotope labels (iron).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28661.081.09 |