Effect of multiple micronutrient-fortified bouillon on micronutrient status among women and children in the Northern Region of Ghana: Protocol for the Condiment Micronutrient Innovation Trial (CoMIT), a community-based randomized controlled trial.

INTRODUCTION: Micronutrient deficiencies are prevalent in West Africa, particularly among women of reproductive age (WRA) and young children. Bouillon is a promising food fortification vehicle due to its widespread consumption. This study aims to evaluate the impact of multiple micronutrient-fortified bouillon cubes, compared to control bouillon cubes (fortified with iodine only), on micronutrient status and hemoglobin concentrations among lactating and non-lactating WRA and young children in northern Ghana. METHODS: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate multiple micronutrient deficiencies are common. Participants will be: 1) non-pregnant non-lactating WRA (15-49 y), 2) children 2-5 y, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes: 1) a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2) a control cube containing iodine only. Each participant's household will receive a ration of bouillon cubes every 2 weeks, and households will be advised to prepare meals as usual, using the study-provided cubes. The trial duration will be 9 months for non-pregnant non-lactating WRA and children, and 3 months for lactating women. The primary outcomes will be changes in biomarkers of micronutrient status and hemoglobin among WRA and children and milk micronutrient concentrations among lactating women. Secondary outcomes will include change in prevalence of micronutrient deficiency and anemia; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and child growth and development. DISCUSSION: Evidence from this study will inform discussions about bouillon fortification in Ghana and West Africa. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT05178407) and the Pan-African Clinical Trial Registry (PACTR202206868437931). This manuscript reflects protocol version 4 (August 29, 2022).

Acceptability of Multiple Micronutrient-Fortified Bouillon Cubes among Women and Their Households in 2 Districts in The Northern Region of Ghana.

Background: Bouillon is a promising large-scale food fortification vehicle, but there is uncertainty regarding the types and concentrations of micronutrients that are feasible to add without compromising consumer acceptability. Objective: The objective of this study was to evaluate the acceptability of 2 different multiple micronutrient-fortified bouillon cube formulations, compared with a bouillon cube fortified with iodine only. Methods: We conducted a double-blind, randomized, controlled acceptability study in 2 districts in northern Ghana. Two nonproprietary, noncommercialized formulations of multiple micronutrient-fortified bouillon cubes containing iron, zinc, folic acid, vitamins A and B12, and iodine at "upper-level" (45-125% CODEX NRV/2.5g) or "lower-level" (15-50% CODEX NRV/2.5g) concentrations, and a control cube that contained iodine only (50% CODEX NRV/2.5g) were evaluated. Eligible women (n = 84) were invited to participate in 1) center-based sensory evaluations designed to permit within-individual comparisons among the different study products; and 2) in-home evaluation of bouillon acceptability and use, in which participants were randomized to receive 1 of the 3 study products to use in household cooking for a 2-wk period. Acceptance test ratings were based on a 5-point Likert scale (1 = dislike very much, 5 = like very much). Results: In the center-based evaluations, overall liking of the 3 bouillon cube formulations both dry and in prepared dishes ranged from 4.3 to 4.6 on the 5-point Likert scale and did not differ among formulations (P > 0.05). After the 2-wk in-home trial, 93.8% of index participants (n = 75/80) rated their overall liking of the bouillon product formulation to which they were randomly assigned as "like" or "like very much" (4-5 on the 5-point Likert scale) and median apparent intake of study-provided bouillon over 2 wk was 3.6 g/capita/d; neither value differed by study group (P = 0.91 for both). Conclusions: All 3 formulations of bouillon cubes assessed were acceptable to women and their households in 2 districts in northern Ghana.This trial was registered at www.clinicaltrials.gov as NCT05177614.

Consumption of Discretionary Salt and Salt from Bouillon among Households, Women, and Young Children in Northern Region, Ghana: A Mixed-Methods Study with the Condiment Micronutrient Innovation Trial (CoMIT) Project.

Background: Information on salt consumption patterns is needed to inform the need for and design of salt reduction strategies. Objectives: In northern Ghana, this study aimed to estimate household consumption of salt, including salt from bouillon, and compare (estimated) women and children's salt intake to global recommendations; to estimate the proportion of salt consumed from bouillon; and to identify factors, including knowledge, attitudes, and practices, associated with household salt consumption. Methods: Employing mixed-methods methodology, we conducted a pilot survey (n = 369 households enrolled) and focus group discussions (FGDs; n = 20) in Tolon and Kumbungu districts (14 urban, 14 rural clusters) (clinicaltrials.gov registry: NCT04632771). Households reported purchases of discretionary salt (DS, "table salt") and bouillon cubes. DS and total salt (TS; DS+salt from bouillon) consumption for women (15-49 y) and children (2-5 y) were estimated using the Adult Male Equivalent method and compared with global recommendations (<5 g/d women; <3.75 g/d children). Women's salt intake was also predicted from urinary sodium excretion (INTERSALT equation). Associations between DS and TS consumption, as well as household and women's characteristics, were tested with minimally adjusted and multivariable linear mixed-effects models. Qualitative FGD themes were generated using the Framework Method. Results: From household purchase data, estimated TS consumption exceeded global recommendations for 44% of children [median: 2.9 (IQR: 1.9, 5.2) g/d] and 60% of women [6.0 (4.0, 10.2) g/d]; 35% of children and 50% of women exceeded recommendations from DS alone. Bouillon contributed <25% of households' TS consumption. Few characteristics were associated with DS or TS consumption. Salient qualitative themes that shaped salt consumption behaviors included salt's ubiquity as a seasoning, key household members' influence on food procurement and preparation, and perceptions about health. Conclusions: Purchase data suggest salt consumption among women and children exceeds recommendations, even when excluding salt from bouillon; food prepared outside the home likely further contributes. Salt reduction interventions may be warranted in this context.

The Relationship Between Ferritin and BMI is Mediated by Inflammation Among Women in Higher-Income Countries, But Not in Most Lower-Income Countries Nor Among Young Children: A Multi-Country Analysis.

Background: In the presence of inflammation, the serum or plasma ferritin concentration ("ferritin" hereafter) transiently increases, confounding its interpretation as an iron status marker. The extent to which adiposity-related inflammation may influence ferritin interpretation is uncertain. Objectives: We describe relationships between weight status, inflammation, and ferritin among nonpregnant women of reproductive age (WRA; 15-49 years) and preschool-age children (PSC; 6-59 months) with normal weight to overweight or obesity (OWOB) in differing geographic settings. Methods: Cross-sectional data were separately analyzed from 18 surveys (WRA) and 25 surveys (PSC) from the Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) project, excluding observations with underweight, wasting, pregnancy, or malaria. Relationships were assessed between BMI (in WRA) or BMI-for-age z-score (BAZ; in PSC), inflammatory biomarkers of C-reactive protein (CRP) and/or α-1-acid glycoprotein (AGP), ferritin by linear regression, and potential mediation by CRP and/or AGP in relationships between BMI or BAZ and ferritin with structural equation modeling. Regression and mediation models accounted for complex survey designs. Results were grouped by World Bank income classifications. Results: In 5 of 6 surveys among WRA from upper-middle and high-income countries, ferritin was significantly positively associated with BMI, and this relationship was partially (or fully, in the United States) mediated by CRP and/or AGP. Mediation was present in 4 of 12 surveys for WRA in low- and lower-middle income countries. Among PSC, ferritin was positively associated with CRP and/or AGP in all surveys, but there were no significant CRP- or AGP-mediated relationships between ferritin and BAZ, except a negative relationship in the Philippines. Conclusions: Where having OWOB is common among WRA, measurements of inflammatory biomarkers and their uses in interpreting ferritin may improve iron status assessments. While these relationships were inconsistent among PSC, inflammation was common and should be measured to interpret iron status. Included Kenyan trial data are registered at clinicaltrials.gov as NCT01088958.

The Double Burden of Malnutrition: A Systematic Review of Operational Definitions.

BACKGROUND: Despite increasing research on the double burden of malnutrition (DBM; i.e., coexisting over- and undernutrition), there is no global consensus on DBM definitions. OBJECTIVES: To identify published operational DBM definitions, measure their frequency of use, and discuss implications for future assessment. METHODS: Following a structured search of peer-reviewed articles with terms describing "overnutrition" [e.g., overweight/obesity (OW/OB)] and "undernutrition" (e.g., stunting, micronutrient deficiency), we screened 1920 abstracts, reviewed 500 full texts, and extracted 623 operational definitions from 239 eligible articles. RESULTS: We organized three identified DBM dimensions (level of assessment, target population, and forms of malnutrition) into a framework for building operational DBM definitions. Frequently occurring definitions included coexisting: 1) OW/OB and thinness, wasting, or underweight (n = 289 occurrences); 2) OW/OB and stunting (n = 161); 3) OW/OB and anemia (n = 74); and 4) OW/OB and micronutrient deficiency (n = 73). CONCLUSIONS: Existing DBM definitions vary widely. Putting structure to possible definitions may facilitate selection of fit-for-purpose indicators to meet public health priorities.

Gaps in international nutrition and child feeding guidelines: a look at the nutrition and young child feeding education of Ghanaian nurses.

OBJECTIVE: To examine the nutrition and young child feeding (YCF) education and training of nurses in public health clinics of Ghana's Komenda-Edina-Eguafo-Abrem region (KEEA) in relation to global health guidelines, and how nurses served as educators for caregivers with children aged 0-5 years. DESIGN: A qualitative study of semi-structured one-on-one and group interviews (n 21) following a questionnaire of closed- and open-ended questions addressing child feeding, nutrition and global health recommendations. Interviews were conducted in English, audio-recorded, transcribed and coded. Descriptive data were tabulated. Content analysis identified themes from open-ended questions. SETTING: KEEA public health clinics (n 12). SUBJECTS: Nurses (n 41) purposefully recruited from KEEA clinics. RESULTS: A model capturing nurses' nutrition and YCF education emerged with five major themes: (i) adequacy of nurses' basic knowledge in breast-feeding, complementary feeding, iron-deficiency anaemia, YCF and hygiene; (ii) nurses' delivery of nutrition and YCF information; (iii) nurses' evaluation of children's health status to measure education effectiveness; (iv) nurses' perceived barriers of caregivers' ability to implement nutrition and YCF education; and (v) a gap in global health recommendations on YCF practices for children aged 2-5 years. CONCLUSIONS: Nurses demonstrated adequate nutrition and YCF knowledge, but reported a lack of in-depth nutrition knowledge and YCF education for children 2-5 years of age, specifically education and knowledge of YCF beyond complementary feeding. To optimize child health outcomes, a greater depth of nutrition and YCF education is needed in international health guidelines.