Enrichment of Blood Clinical Trial
Official title:
A Multiple Meal Study to Evaluate the Role of Phytic Acid From Beans on Human Iron Absorption
| Verified date | November 2012 |
| Source | Swiss Federal Institute of Technology |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Ethikkommission |
| Study type | Interventional |
Iron deficiency and iron deficiency anemia are among the major health problems in the
developing world. Women of childbearing age as well as children are the most vulnerable
population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A
promising approach to combat iron deficiency in Rwanda is biofortification of beans. The
average consumption of beans is about 150 g per person per day in Rwanda and beans are a
major staple food. Traditional plant breeding has increased the iron content of certain bean
varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3%
low because of high phytate and high polyphenol contents. A recently conducted study in
Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was
similar to the amount of iron absorbed from a control bean, which had a 50% lower iron
concentration. This was surprising since the subjects had a low iron status and where
therefore expected to maximize iron absorption. However, it was concluded that the
additional iron bred into the bean was not bioavailable most likely due to the strong
inhibitory nature of phytate in the high iron bean. To clarify that, a multiple meal study
(iron absorption study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and
the Medical Faculty of the National University of Rwanda is planned. Subjects will receive
two different bean varieties (normal iron vs. high iron) in combination with other food
ingredients typical for that region. The bean varieties will be served with native phytate
concentration, partially dephytinized (50%) or totally dephytinized.
Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption
will be determined by stable isotope techniques.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | September 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 35 Years |
| Eligibility |
Inclusion Criteria: - Non-pregnant, non-lactating women - Between 18 and 40 years - Below 65kg Exclusion Criteria: - Metabolic, chronic and gastro-intestinal disease - Long-term medication - Blood donation within 6 month before the study |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Rwanda | National University of Rwanda (NUR) | Butare |
| Lead Sponsor | Collaborator |
|---|---|
| Swiss Federal Institute of Technology |
Rwanda,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The impact of different bean phytic acid concentrations on iron absorption measured by stable iron isotope techniques | 3 month | No |