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

NCT04092517 | Completed

• 1 other identifier: UAberdeen
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnourishment

Keywords

phytochemicals; systemic circulation

Outcome Measures

Primary Outcomes (1)

• Change in concentration of phytochemical metabolites in the systemic circulation

  Difference in concentration of phytochemical metabolites between baseline and postprandial states

  up to 24 hours

Study Arms (2)

Control Corn Soya Diet

ACTIVE COMPARATOR

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.

Other: Control Corn Soya Diet

Test Corn Moringa Diet

EXPERIMENTAL

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.

Other: Test Corn Moringa Diet

Interventions

Control Corn Soya Diet OTHER

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)

Control Corn Soya Diet

Test Corn Moringa Diet OTHER

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

Test Corn Moringa Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Wendy Russell, PhD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: September 17, 2019
• Study Start: September 13, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 31, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)