This study aims to evaluate the acceptability of bouillon cubes fortified with six micronutrients for which deficiency is common among women and children in Ghana and to assess the feasibility and reliability of data collection methods to be used in a planned, more detailed study to evaluate the effect of multiple micronutrient (MN)-fortified bouillon cube on biomarkers of nutrient status, health and development of women and children.
Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by many households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible, acceptable and effective for preventing micronutrient deficiencies in communities where such deficiencies are common. Objectives: This study aims (1) to evaluate the acceptability of bouillon cubes formulated with 6 micronutrients for which deficiency is common among women and children in Ghana and (2) to access the feasibility and reliability of data collection methods to be used in a later study of the effects of fortified bouillon, compared to control, on micronutrient status, health, and development. Methods: This acceptability study will be conducted in the Kumbungu and Tolon districts in the Northern Region, where a recent survey showed that micronutrient deficiencies were common. The investigators will recruit non-pregnant adult women (15+ years old) (n = 84) who are responsible for household meal preparation, to participate in sensory testing of an uncooked fortified bouillon as well as a cooked food containing the fortified bouillon. Subsequently, participants will receive a 14-day supply of fortified bouillon cubes to use at home, after which they will be asked their opinions about the bouillon. Three fortified bouillon formulations will be tested: 1) upper-level bouillon, fortified with iron, zinc, iodine, vitamin A, folic acid, and vitamin B-12, 2) lower-level bouillon, containing the same 6 micronutrients but with lower concentrations of some micronutrients, and 3) a control bouillon, fortified with iodine only. Participants will be in the study for approximately 18 days (study day 0 to study day 17). In addition, children 2-6 years of age in households of enrolled women will be eligible to participate in a pilot study to evaluate the feasibility and test-retest reliability of several methods to assess child development. For these children, child development will be assessed at two home visits during the 14-day period of fortified bouillon use at home.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
84
80 µg/g Folic acid 1.2 µg/g Vitamin B12 3 mg/g Zinc (ZnO) 4 mg/g Iron (FePP/citric acid/trisodium citrate) 200 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)
28.8 µg/g Folic acid 0.288 µg/g Vitamin B12 1.68 mg/g Zinc (ZnO) 1.3 mg/g Iron (FePP/citric acid/trisodium citrate) 96 µg/g Vitamin A (retinyl palmitate) 30 µg/g Iodine (KIO3)
30 µg/g Iodine (KIO3)
University of Ghana
Accra, Ghana
Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked)
* centre-based * ratings of sensory attributes (appearance, feel, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics ("just-about-right" and "check-all-that-apply)
Time frame: Study day 1
Sensory perceptions of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
* centre-based, soup dish randomly assigned to be consumed on study day 1 or 2 * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics ("just-about-right" and "check-all-that-apply")
Time frame: Study day 1 or 2
Sensory perceptions of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
* centre-based, rice-based dish randomly assigned to be consumed on study day 1 or 2 * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics ("just-about-right" and "check-all-that-apply")
Time frame: Study day 1 or 2
Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked)
* centre-based * triangle test (ability to identify the odd sample correctly)
Time frame: Study day 1
Preference test of multiple micronutrient-fortified bouillon cubes (uncooked)
* centre-based * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste)
Time frame: Study day 1
Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes
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* centre-based, soup dish randomly assigned to be consumed on study day 1 or 2 * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste) when prepared in commonly consumed dishes
Time frame: Study day 1 or 2
Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes
* centre-based, rice-based dish randomly assigned to be consumed on study day 1 or 2 * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste) when prepared in commonly consumed dishes
Time frame: Study day 1 or 2
Consumption of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
* centre-based, soup dish randomly assigned to be consumed on study day 1 or 2 * acceptability of multiple micronutrient-fortified bouillon cubes based on percent of test portions consumed (of commonly consumed dishes cooked with multiple micronutrient-fortified bouillon cubes)
Time frame: Study day 1 or 2
Consumption of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
* centre-based, rice-based dish randomly assigned to be consumed on study day 1 or 2 * acceptability of multiple micronutrient-fortified bouillon cubes based on percent of test portions consumed (of commonly consumed dishes cooked with multiple micronutrient-fortified bouillon cubes)
Time frame: Study day 1 or 2
Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
* in-home acceptability trial (2 weeks), study-provided bouillon cubes used in all household cooking * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics ("just-about-right" and "check-all-that-apply")
Time frame: Study day 17
Quantity of study-provided bouillon cubes used
* in-home acceptability trial (2 weeks) * number of study-provided bouillon cubes used in household over two week trial period
Time frame: Study day 17
Study-provided bouillon cube use as a proportion of total bouillon use
* in-home acceptability trial (2 weeks) * number of study-provided bouillon cubes used in household over two week trial period, as a proportion of all household bouillon use (study-provided plus non-study provided)
Time frame: Study day 17
Change in child development scores on the Malawi Developmental Assessment Tool (MDAT)
* gross motor, fine motor, language, and personal-social scores * measured twice during study to assess test-retest reliability * intraclass correlation coefficient of MDAT
Time frame: From study day 3 to study day 17 (2 weeks)
Change in Responsive care and learning opportunities in the home environment: Home Observation for the Measurement of the Environment (HOME) Inventory score
* measured twice during study to assess test-retest reliability * intraclass correlation coefficient of HOME inventory
Time frame: From study day 3 to study day 17 (2 weeks)
Household-level consumption of salt
* patterns of salt use prior to the study (pre-intervention) * assessed at the initial study visit
Time frame: Study day 0
Household-level consumption of bouillon
* patterns of bouillon use prior to the study (pre-intervention) * assessed at the initial study visit
Time frame: Study day 0
Change in willingness to pay for multiple micronutrient-fortified bouillon cubes
* assessed pre- and post-intervention * hypothetical willingness-to-pay for multiple micronutrient-fortified bouillon cubes before and after exposure to the study-provided bouillon cubes
Time frame: Study day 1 and 17
Themes from focus group discussions
* acceptability of the multiple micronutrient-fortified bouillon cubes, experiences of using the multiple micronutrient-fortified bouillon cubes in daily cooking and willingness to use multiple micronutrient-fortified bouillon cubes in the future * pre- and post-intervention * conducted using a structured focus group discussion guide
Time frame: Study day 2 and 17
Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes
* post-intervention * questionnaire to assess perceived positive and negative health effects
Time frame: Study day 17
Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
* mid-point of in-home acceptability trial (1 week), study-provided bouillon cubes used in all household cooking * ratings of sensory attributes (appearance, smell, taste and overall) on 5 point hedonic scales * ratings of presence of specific organoleptic characteristics ("just-about-right" and "check-all-that-apply")
Time frame: Study day 9