High Fe OFSP meal labelled with Fe-58
Other400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
NCT Number: NCT03840031
To combat iron deficiency in Low and Middle-Income Countries, sustainable food-based solutions have to be implemented to serve populations, not only individuals. One solution is the introduction of iron biofortified staple crops on market level. Before market level introduction, the bioavailability of iron in the new biofortified Orange Fleshed Sweet Potato (OFSP) breed needs to be assessed. In this study the investigator compares the fractional and total iron absorption after extrinsic stable isotope labelling of the new biofortified high iron OFSP variety and a normal market level OFSP variety. The study is conducted in Malawian women of reproductive age with marginal iron status.
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Notify Me18 year–35 year
Female
Interventional
Not applicable
Training and Research Unit of Excellence, University of Malawi, Zomba, Malawi
The 25 women enrolled will consume test meals consisting of 400g steamed and mashed high iron sweet potatoes labelled with Fe-58 daily for a period of 10 days and will then switch to the test meals consisting of 400g steamed and mashed control sweet potatoes labelled with Fe-57 for a period of 10 days. The order of test meal type is random. A baseline blood sample will be taken on the first meal feeding day prior to consumption of any test meals, on study day 26 (14 days after completion of the first test meal period) and on Day 40 (14 days after completion of the second test meal period). Erythrocyte incorporation of the stable isotope labels will be measured in these blood samples using an ICPMS and will be used to calculate fractional and total iron absorption from the two different type of test meals.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
Time frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
Proportion of stable isotope administered with test meals that has been incorporate into erythrocytes 14 days after completion of specific test meal feeding period
Time frame: Measured 2 weeks after completion of feeding day sequence. Sequence consist of 2 times 10 feeding days.
Amount of iron absorbed (mg) from the labelled test meals
Time frame: screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
Iron status marker
Time frame: screening (-1), baseline (day 1), last test meal consumption (day 26) and 14 days after last test meal consumption (day 40)
Inflammation status marker
Swiss Federal Institute of Technology
Other
SASHA-II Iron Bioavailability From Iron-biofortified Orange Fleshed Sweet Potato in Malawian Women Between 18-35 Years
Acronym: SASHA-II
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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