In vitro determination of the protein quality of maize varieties cultivated in Malawi using the INFOGEST digestion method.

There is an urgent need to alleviate protein deficiencies in low-income countries where cereal-based diets dominate. The objective of this study was to use the INFOGEST static digestion method and a recently established analytical workflow to determine the in vitro amino acid digestibility and protein quality of seven maize varieties grown in Malawi. Protein quality was measured using the in vitro digestible indispensable amino acid score (DIAAS). Amino acid digestibility was higher for the dehulled, low fibre, provitamin A maize flour (66%), compared to whole grain maize flours (51-61%), suggesting that the presence of fibre reduced digestibility (p < 0.05). Lysine was the limiting amino acid in all varieties, with the following DIAAS values for each variety; Provitamin A maize - 24, SC 719 - 32, Mtsikinya - 37, SC 167 - 39, Quality protein maize (QPM) - 40, Bantum - 40, SC 403 - 44. In addition to the variety of maize, protein quality was dependent on the level of processing and the agronomic practice applied with higher protein quality for the SC 403 variety in which zinc enriched fertilizer was applied. Comparing protein quality data with published in vivo data showed that DIAAS data were in closer agreement than amino acid digestibility data, which was slightly lower than published values, with mean in vitro amino acid digestibilities of 56-70% compared to a mean in vivo value of 77%. Overall, the in vitro method was able to correctly predict both the direction and magnitude of response. The INFOGEST digestion method coupled with the new analytical workflow will therefore be useful in the screening of high protein cereal crops and subsequent development of cereal-based foods with high protein quality.

Hydrothermally-treated soybean-fortified maize-based nsima (stiff porridge) could contribute towards alleviating seasonal body weight loss in farming communities in sub-Saharan Africa.

Objective: This study explored the use of hydrothermally-treated soybean-fortified maize-based stiff porridge (nsima) in managing body weight losses among the farming family community in Malawi during the labour-intensive cropping (growing) season. We hypothesized that soybean-fortified maize-based nsima could prevent seasonal body weight losses in farming communities during labour-intensive seasons better than conventional 100% maize nsima. Research methods & procedures: A single-blind parallel dietary intervention 90-day study. During energy stress months, 42 farming households in Malawi were supplied with 15 kg of blind formulation of soybean-fortified maize flour (soybean: maize, 1:4, wt/wt) per person per month except for under-fives who were allotted half the quantity. Forty households were provided with equivalent quantities of 100% maize flour and served as control. Body weights of participants were taken at baseline and endpoint. Results: After 3 months, the experimental group registered 3.7, 4.2, 2.9, and 5.2% statistically higher body weight compared to the controls for the under-five, the 5-9-year-olds, the 10-19-year-olds, and the >20-year-olds, respectively. Conclusion: Soybean-fortified stiff porridge could feasibly be used to alleviate wasting among the resource-constraint populace in Malawi and many other parts of sub-Saharan Africa that rely on maize as a major staple.

Reduction of aflatoxins during brewing of a Malawian maize-based non-alcoholic beverage, thobwa.

This study reports onthe effect of various production steps on levels of aflatoxins during preparation of thobwa, a traditional maize-based fermented non-alcoholic beverage, brewed across Malawi. The effect of boiling, fermentation and their interaction on the level of aflatoxins, the trends of aflatoxin reduction during brewing, and the distribution of aflatoxins between the solid and liquid phases of the beverage were studied using VICAM AflaTest immunoaffinity fluorometric assay. Fermenting and boiling thobwa pre-mix-, with initial aflatoxin content of 45-183 µg/kg, resulted in aflatoxin reduction of 47% (13-61 µg/kg) on average. Fermentation and boiling contributed about 20 and 33% aflatoxin reduction, respectively, but without interactive effect between the two factors. Fermenting the thobwa for 24 h led to further reduction of aflatoxins to about 37% of the initial content, and remainedconstant for up to 8 days. Thobwa is a popular beverage in Malawi which is consumed in large quantities by all gender categories including infants, therefore the presence of aflatoxins may constitute a significant health risk factor. This study highlights the need to use raw materials with low levels of aflatoxins for production of maize-based non-alcoholic beverages to ensure consumer safety.

Examining study participants' decision-making and ethics-related experiences in a dietary community randomized controlled trial in Malawi.

BACKGROUND: The participant recruitment process is a key ethical pivot point when conducting robust research. There is a need to continuously review and improve recruitment processes in research trials and to build fair and effective partnerships between researchers and participants as an important core element in ensuring the ethical delivery of high-quality research. When participants make a fair, informed, and voluntary decision to enroll in a study, they agree to fulfill their roles. However, supporting study participants to fulfill study requirements is an important ethical obligation for researchers, yet evidenced as challenging to achieve. This paper reports on participants' motivations to volunteer and remain part of a dietary study conducted in Kasungu District, Malawi. METHODS: We conducted twenty in-depth interviews (with chiefs, religious leaders, trial participants, and health surveillance assistants), five systematic ethnographic observations, and fourteen focus group discussions with trial participants and their partners. Interviews were audio-recorded and transcribed verbatim. We used a grounded theory methodology to analyse data that included coding, detailed memo writing, and data interpretation. FINDINGS: The findings reveal that many participants had concerns during the trial. Thematically, experiences included anxieties, mistrust of researchers, rumours, fears of exploitation, and misconceptions. Anonymous concerns collected from the participants were reported to the trial team which enabled the researchers to appropriately support participants. Despite initial concerns, participants described being supported and expressed motivation to take up their role. CONCLUSION: These findings highlight a diverse map of multiple notions of what is ethically relevant and what can impact participation and retention within a study. The study has revealed how embedding a responsive approach to address participants' concerns and ethical issues can support trust relationships. We argue for the need to employ embedded ethics strategies that enhance informed consent, focus on participants' needs and positive experiences, and support researchers to fulfill their roles. This work highlights the need for research ethics committees to focus on the risks of undue influence and prevent exploitation especially in settings with a high asymmetry in resources and power between researcher and participant groups. TRIAL REGISTRATION: The Addressing Hidden Hunger with Agronomy (Malawi) trial was registered on 5th March 2019 (ISCRTN85899451).

Preparing for a community-based agriculture-to-nutrition trial in rural Malawi: formative research to assess feasibility and inform design and implementation decisions.

BACKGROUND: This study reports findings from formative research conducted to assess the feasibility and inform the design and implementation of the Addressing Hidden Hunger with Agronomy (AHHA) trial. The AHHA trial was a randomised, controlled trial conducted in rural Malawi, in which participants were given maize flour biofortified with selenium or control flour not biofortified with selenium for a period of 10 weeks, after which blood samples were taken to measure selenium status. METHODS: Formative research was conducted in villages near to the AHHA trial study site 1 year before the planned intervention. A short questionnaire with adult women (n = 50), focus group discussions with male (n groups = 3) and female (n groups = 3) community members, and in-depth key informant interviews (n = 7) were conducted to understand community practices and perceptions. FINDINGS: Meals were typically cooked and eaten at home in this community, while participants reported that maize flour would be less readily sold than maize grain - important considerations for the design of the trial. Regarding intervention delivery, we identified potential concerns around effects on fertility, links between blood sampling and witchcraft, and the potential for social stigma if community members considered participants lazy for receiving free flour. Participants reported that involvement of the Malawi government partners including health extension workers would increase trust. INTERPRETATION: Following the formative research, the AHHA trial appeared feasible. However, community sensitisation would be essential to address potential fears and concerns; effective sensitisation would support recruitment and treatment adherence, and would protect the safety and wellbeing of participants and researchers. People in positions of authority and trust including village headmen, religious leaders, health and agriculture extension workers, and community care groups should be involved in community sensitisation.

Biofortified Maize Improves Selenium Status of Women and Children in a Rural Community in Malawi: Results of the Addressing Hidden Hunger With Agronomy Randomized Controlled Trial.

Background: Selenium deficiency is widespread in the Malawi population. The selenium concentration in maize, the staple food crop of Malawi, can be increased by applying selenium-enriched fertilizers. It is unknown whether this strategy, called agronomic biofortification, is effective at alleviating selenium deficiency. Objectives: The aim of the Addressing Hidden Hunger with Agronomy (AHHA) trial was to determine whether consumption of maize flour, agronomically-biofortified with selenium, affected the serum selenium concentrations of women, and children in a rural community setting. Design: An individually-randomized, double-blind placebo-controlled trial was conducted in rural Malawi. Participants were randomly allocated in a 1:1 ratio to receive either intervention maize flour biofortified with selenium through application of selenium fertilizer, or control maize flour not biofortified with selenium. Participant households received enough flour to meet the typical consumption of all household members (330 g capita -1 day-1) for a period of 8 weeks. Baseline and endline serum selenium concentration (the primary outcome) was measured by inductively coupled plasma mass spectrometry (ICP-MS). Results: One woman of reproductive age (WRA) and one school-aged child (SAC) from each of 180 households were recruited and households were randomized to each group. The baseline demographic and socioeconomic status of participants were well-balanced between arms. No serious adverse events were reported. In the intervention arm, mean (standard deviation) serum selenium concentration increased over the intervention period from 57.6 (17.0) µg L-1 (n = 88) to 107.9 (16.4) µg L-1 (n = 88) among WRA and from 46.4 (14.8) µg L-1 (n = 86) to 97.1 (16.0) µg L-1 (n = 88) among SAC. There was no evidence of change in serum selenium concentration in the control groups. Conclusion: Consumption of maize flour biofortified through application of selenium-enriched fertilizer increased selenium status in this community providing strong proof of principle that agronomic biofortification could be an effective approach to address selenium deficiency in Malawi and similar settings. Clinical Trial Registration: http://www.isrctn.com/ISRCTN85899451, identifier: ISRCTN85899451.

Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial.

BACKGROUND: Micronutrient deficiencies including selenium (Se) are widespread in Malawi and potentially underlie a substantial disease burden, particularly among poorer and marginalised populations. Concentrations of Se in staple cereal crops can be increased through application of Se fertilisers - a process known as agronomic biofortification (agro-biofortification) - and this may contribute to alleviating deficiencies. The Addressing Hidden Hunger with Agronomy (AHHA) trial aims to establish the efficacy of this approach for improving Se status in rural Malawi. METHODS: A double-blind, randomised, controlled trial will be conducted in a rural community in Kasungu District, Central Region, Malawi. The hypothesis is that consumption of maize flour agro-biofortified with Se will increase serum Se concentration. We will recruit 180 women of reproductive age (WRA) (20-45 years) and 180 school-age children (SAC) (5-10 years) randomly assigned in a 1:1 ratio to receive either maize flour enriched through agro-biofortification with Se or a control flour not enriched with Se. Households will receive flour (330 g per capita per day) for 12 weeks. The primary outcome is Se concentration in serum (µg/L). Serum will be extracted from venous blood samples drawn at baseline (prior to flour distribution) and end-line. Selenium concentration will be measured by using inductively coupled plasma mass spectrometry. DISCUSSION: Findings will be communicated to policy stakeholders and participating communities and reported in peer-reviewed journals. TRIAL REGISTRATION: The Addressing Hidden Hunger with Agronomy (Malawi) trial is registered (5th March 2019; ISCRTN85899451).

Reduced Morbidity Motivated Adoption of Infant and Young Child Feeding Practices after Nutrition Education Intervention in Rural Malawi.

This study assessed caregivers' knowledge and practices and factors that influence the adoption of improved infant and young child feeding (IYCF) practices after nutrition education in Kasungu and Mzimba districts among 198 caregivers. Mixed-methods convergent-parallel design, including knowledge tests, focus group discussions, and in-depth interviews in the intervention areas, was used to collect quantitative and qualitative data. Data were analyzed using count regression and content analysis, which showed that knowledge increased among caregivers after nutrition education. The knowledge about diet diversification for young children as well as about hygienic practices when preparing food and during feeding improved in addition. Enhanced health among children motivated caregivers to apply improved IYCF practices. The study was based on the caregivers' reports. Long-term effects of exposure to nutrition education are unknown. However, the nutrition education that focused on the child's health benefits motivated mothers to adopt improved IYCF practices.