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

Primary Purpose

Malnourishment

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Control Corn Soya Diet
Test Corn Moringa Diet
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnourishment focused on measuring phytochemicals, systemic circulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Aberdeen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Corn Soya Diet

Test Corn Moringa Diet

Arm Description

Control 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.

Test 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.

Outcomes

Primary Outcome Measures

Change in concentration of phytochemical metabolites in the systemic circulation
Difference in concentration of phytochemical metabolites between baseline and postprandial states

Secondary Outcome Measures

Full Information

First Posted
October 15, 2018
Last Updated
September 16, 2019
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT04092517
Brief Title
MORINGA; Delivering Nutrition and Economic Value to the People of Malawi
Official Title
MORINGA; Delivering Nutrition and Economic Value to the People of Malawi
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnourishment
Keywords
phytochemicals, systemic circulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Corn Soya Diet
Arm Type
Active Comparator
Arm Description
Control 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.
Arm Title
Test Corn Moringa Diet
Arm Type
Experimental
Arm Description
Test 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.
Intervention Type
Other
Intervention Name(s)
Control Corn Soya Diet
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Test Corn Moringa Diet
Intervention Description
Ingredients (% by weight): Maize (78.30); Moringa (20.0)
Primary Outcome Measure Information:
Title
Change in concentration of phytochemical metabolites in the systemic circulation
Description
Difference in concentration of phytochemical metabolites between baseline and postprandial states
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy males or females; BMI 18-35; Age 18+ Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Russell, PhD
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aberdeen
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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