Acceptability of Fortified Bouillon Cubes in Northern Ghana

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study to Evaluate the Acceptability of a Multiple Micronutrient-fortified Bouillon Cube in Women and Their Households in Two Districts in the Northern Region of Ghana

Conditions
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Food, Fortified, Dietary Habits, Child Development

Intervention / Treatment
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* Dietary Supplement: Upper-level multiple micronutrient-fortified bouillon cube
* Dietary Supplement: Lower-level multiple micronutrient-fortified bouillon cube
* Dietary Supplement: Iodine-fortified bouillon cube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acceptability study: self-reported non-pregnant adult women (15+ years) responsible for meal preparation in the household signed the informed consent form Child development assessment pilot sub-study: 2-6 years of age (24-71 months) residing in the same household as an enrolled woman child's primary caregiver signs the informed consent form Exclusion Criteria: severe illness warranting immediate hospital referral COVID-19 exposure, positive test, or current symptoms (including fever, cough, shortness of breath, loss of smell, vomiting, or diarrhea [> 3 liquid or semi-liquid stools in 24h]) of illness chronic severe medical condition (e.g. malignancy) or congenital anomalies requiring frequent medical attention or potentially interfering with nutritional status or affecting child development (children only) presence of ailments (such as toothache, or mouth pain) that may impact a participant's ability to complete study activities (women only) unable to provide informed consent due to impaired decision making abilities current participation in a clinical trial reported shrimp, wheat, milk, soy, eggs, celery, fish, or mollusc allergy, or a previous adverse reaction to bouillon by anyone in the household refusal to use provided bouillon cubes to prepare household meals while enrolled in the study

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants will participate in sensory testing (acceptability, preference and discrimination testing) of three uncooked fortified bouillon cubes (upper-level, lower-level and control), as well as cooked foods containing the three different bouillon cubes. Participants will then be randomized to one of three groups (upper-level, lower-level or control), and receive a 14 day supply of study-provided bouillon cubes to use at home.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper-level multiple micronutrient-fortified bouillon cube<br>10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients | Dietary Supplement: Upper-level multiple micronutrient-fortified bouillon cube<br>* 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)<br>|
| Experimental: Lower-level multiple micronutrient-fortified bouillon cube<br>10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients | Dietary Supplement: Lower-level multiple micronutrient-fortified bouillon cube<br>* 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)<br>|
| Placebo Comparator: Control (iodine-fortified bouillon cube)<br>10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with one micronutrient | Dietary Supplement: Iodine-fortified bouillon cube<br>* 30 µg/g Iodine (KIO3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | 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) | Study day 1 | 
| Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes | 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 | 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 | 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) | 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) | 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) | 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 | 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) | 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 | 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 | From study day 3 to study day 17 (2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Household-level consumption of salt | patterns of salt use prior to the study (pre-intervention) assessed at the initial study visit | Study day 0 | 
| Household-level consumption of bouillon | patterns of bouillon use prior to the study (pre-intervention) assessed at the initial study visit | 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 | 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 | 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 | 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) | Study day 9 |