Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04092517 |
| Other study ID # |
UAberdeen |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 13, 2018 |
| Est. completion date |
March 31, 2019 |
Study information
| Verified date |
September 2019 |
| Source |
University of Aberdeen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Lack of adequate nutrition is the single biggest contributor to child mortality. Malawi is
amongst the countries most affected.
In global feeding programmes several variations of fortified blended foods are used and
imported into the country of need as supplementary foods. However, the accessibility and
efficacy of supplementary feeding is variable and can be a limiting factor for success in
preventing and treating malnutrition. Therefore, in countries with widespread hunger, an
increasing demand exists for innovative strategies offering alternative solutions for
year-round access to commonly consumed home-grown products with good nutritional value.
Moringa Oleifera - described as 'a nutritional and medicinal cornucopia' is common throughout
in Malawi. Moringa leaves can be repeatedly cropped and are rich source of nutrients and
non-nutrient bioactive compounds. These nutritional characteristics give Moringa the
potential to significantly contribute in Malawi's battle against malnutrition and mineral
element deficiencies.
The aim of this study is to compare Moringa as a substitute in specially formulated
supplementary foods in order to evaluate the in vivo bioavailability of key nutrients and
bioactives and biological activities of the plant. This would assess the potential for
establishing Moringa oleifera as an economically viable crop which could contribute towards
establishing a resilient food supply chain in Malawi that will deliver essential nutrients
across the population.
Description:
Lack of adequate nutrition remains the world's most prevalent health problem and the single
biggest contributor to child mortality. It is a direct or indirect cause of 43% deaths
worldwide among children under 5 years of age. The two separate forms of malnutrition -
wasting (a deficit in weight relative to length) and stunting (a deficit in length relative
to age) are closely related and often occur together in the same children, leading to an
increased risk of mortality. Although the prevalence of stunting is decreasing worldwide,
Africa faces a rise in the absolute number of stunted children. Malawi is amongst the
countries most affected in sub-Saharan Africa with 42% of the children being stunted and 4%
wasted.
Maize is the principal food crop and dietary staple in many parts of the developing world
including Malawi. This reliance on maize and the lack of dietary diversity is a significant
contributing factor to micronutrient deficiencies (present in over 30 percent of the
population).
Supplementary feeding by provision of extra nutrient‐dense food beyond the home diet is an
intervention aimed at improving the nutritional status or preventing the nutritional
deterioration of the target population. Multiple socioeconomic and cultural factors play a
role in determining the type and content of supplementary foods provided in different
countries. The acceptability and efficacy of the nutrition support is variable (depending on
sensory perception of the food, price, convenience of preparation, etc.) and can be a
limiting factor for success in preventing and treating moderate and severe acute
malnutrition. In this context there is an increasing demand for innovative strategies
offering alternative solutions for year-round access to commonly consumed home-grown products
with good nutritional value in countries with widespread hunger.
Moringa Oleifera - widely regarded as the 'miracle tree' has been described as 'a nutritional
and medicinal cornucopia'. The Moringa plant is native to Northern India but has become
naturalized in Malawi where it is common throughout. All parts of the plant are usable for
different purposes, but for human and animal nutrition the leaves are the most widely
utilised. Moringa leaves can be repeatedly and sustainably cropped and are rich in macro- and
micronutrients, as well as bioactive compounds. These nutritional characteristics give
Moringa the potential to significantly contribute in Malawi's battle against protein-energy
malnutrition and mineral element deficiencies, providing home-grown feed and food products to
replace/partly replace, with economic advantage, imported nutrient premixes.
Research devoted to nutritional characterisation of Moringa oleifera shows that it is a rich
source of affordable, readily available, essential nutrients and phytoconstituents. The
Moringa foliage is a good source of minerals, carotenoids and tocopherols, polyunsaturated
fatty acids, ascorbic acid, folate and phenolics. Studies in animal models report
significantly higher bioavailability for iron from Moringa foliage when compared to ferric
citrate. Additionally, some major forms of folates were found to be highly bioavailable
compared to other folate-rich foods, such as green leafy vegetables. However, different
factors such as environmental, genetic, postharvest handling, stage of leaf development -
significantly influence nutrient contents of Moringa leaves.
In human studies conducted with Moringa Oleifera to date, no adverse effects are reported and
in many parts of the world its use as a food fortificant is on the increase. However,
although many studies report improvement in the nutritional value of foods fortified with
Moringa Oleifera, none of them show the digestibility (in-vivo or in-vitro) and nutrient
bioavailability and high-quality research on its proposed nutritional and health benefits is
currently scarce.
There are several variations (continuously refined to better meet the nutritional needs of
beneficiaries) of currently endorsed fortified blended foods (FBF) used in global feeding
programmes and imported into the country of need. Corn Soya Blend (CSB) fortified with a
vitamin and mineral premix (SUPER CEREAL) is one such combination provided by the World Food
Programme (WFP). The premix formula used may meet the minimum international standards, but is
manufactured using inorganic compounds, which may not be fully bioavailable.
To the investigators' knowledge no human intervention trials have attempted to compare
Moringa as modification substitute in specially formulated supplementary foods in order to
evaluate in vivo bioavailability of key nutrients and bioactives and biological activities of
the plant. This would give the potential for development for alternative formulations for
locally produced supplementary foods.
Therefore, in this study the investigators aim to assess the nutritional composition of
Moringa leaves (grown in three different sites in Malawi) in terms of macro-, micro- and
non-nutrient composition. The sample with the most favourable profile will be used in a
subsequent human intervention study. With this randomised, controlled, crossover-design study
the investigators aim to evaluate the bioavailability potential of Moringa oleifera in terms
of key nutrients and bioactives when compared with the current nutrient supplement SUPER
CEREAL.
This human study is part of a wider collaborative study "MORINGA; delivering nutrition and
economic value to the people of Malawi", investigating the possibility of establishing
Moringa oleifera as an economically viable crop which will contribute towards launching a
resilient food supply chain in Malawi that will deliver essential nutrients across the
population.
Scientifically proven nutritive benefits of locally grown in Malawi Moringa oleifera could
help to replace currently imported nutrients and products and develop sustainable production
of a high-protein, micronutrient rich crop.
Two types of diets will be prepared:
Control meal: Corn Soya Blend Test meal: Corn Moringa Blend
In an acute intervention, these two test meals will allow us to evaluate the bioavailability
of key nutrients and bioactives provided by Corn Moringa Blend when compared with Corn Soya
Blend fortified with by an addition of a Micronutrient Premix.
In a cross-over fashion subjects will be randomly allocated to consume the Corn Moringa Blend
or the Corn Soya/Micronutrient Premix Blend test meal. The volunteers will be invited to
return to the Human Nutrition Unit (HNU) of the Rowett Institute for two intervention
sessions. Both intervention sessions will be identical in all aspects except for the
composition of the experimental meals.
For the duration of the intervention session (over 24 hour period), the volunteers will be
asked to continue the low phytochemical diet and only consume water for the first five hours
following consumption of the test meal. Each treatment session will be followed by at least
one week wash-out period before crossing over to the second treatment.
