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AzTrials

MalnourishmentNCT04092517

MORINGA; Delivering Nutrition and Economic Value to the People of Malawi

A study testing Test Corn Moringa Diet in people with Malnourishment, run by University of Aberdeen at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Malnourishment
What is being tested?
Test Corn Moringa Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
13 Sep 2018to 31 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males or females;
  • BMI 18-35;
  • Age 18+

Who cannot join

  • Subjects are taking prescribed medication;
  • Subjects are pregnant or breastfeeding;
  • Have given a blood donation in the last three months;
  • Are unable to give written informed consent;
  • Have eating disorders such as anorexia, bulimia, binge eating or night eating syndrome;
  • Report any significant health issue;
  • Subjects are taking vitamin or mineral supplements (unless they agree to discontinue supplementation 2wk before the start of the study);
  • Food allergies/intolerances.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Aberdeen

    Aberdeen, AB25 2ZD

Other trials in United Kingdom

About this study

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.

Read more

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.

Read the detailed 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.

Conditions
Malnourishment
Being tested
Control Corn Soya Diet, Test Corn Moringa Diet
Keywords
phytochemicals, systemic circulation
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Corn Soya DietOther

    Ingredients (% by weight): Maize (78.30); Whole soya beans (20.00); Vitamin/Mineral FBF-V-13 (0.20); Dicalcium Phosphate anhydrous (1.23); Potassium chloride (0.27)

  • Test Corn Moringa DietOther

    Ingredients (% by weight): Maize (78.30); Moringa (20.0)

Study groups in NCT04092517
Study groupRoleWhat they receive
Control Corn Soya DietActive comparatorControl Corn Soya Diet will be prepared to a formulation for Corn Soya Blend (SUPER CEREAL) product adopted by the WFP as complementary food for children over than 6 months.
Receives: Other: Control Corn Soya Diet
Test Corn Moringa DietExperimentalTest Corn Moringa Diet will be prepared to the same formulation as Corn Soya Blend, but the Soya content will be replaced with Moringa and no micronutrient premix will be added.
Receives: Other: Test Corn Moringa Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in concentration of phytochemical metabolites in the systemic circulation

    Difference in concentration of phytochemical metabolites between baseline and postprandial states

    Measured: up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start13 Sep 2018
  3. Primary completion30 Mar 2019
  4. Study completion31 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04092517
Sponsor's protocol ID
UAberdeen
Status last verified
Sep 2019
First submitted
15 Oct 2018
Last updated
17 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Test Corn Moringa Diet in people with Malnourishment, run by University of Aberdeen at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in concentration of phytochemical metabolites in the systemic circulation (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.

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