Clinical trial NCT05177614: Acceptability of Fortified Bouillon Cubes in Northern Ghana
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food, Fortified
Dietary Habits
Child Development
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: Helen Keller International
First posted: 2022-01-04
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked)
timeFrame: Study day 1
measure: Sensory perceptions of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 or 2
measure: Sensory perceptions of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 or 2
measure: Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked)
timeFrame: Study day 1
measure: Preference test of multiple micronutrient-fortified bouillon cubes (uncooked)
timeFrame: Study day 1
measure: Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 or 2
measure: Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 or 2
measure: Consumption of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 or 2
measure: Consumption of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 or 2
measure: Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 17
measure: Quantity of study-provided bouillon cubes used
timeFrame: Study day 17
measure: Study-provided bouillon cube use as a proportion of total bouillon use
timeFrame: Study day 17
measure: Change in child development scores on the Malawi Developmental Assessment Tool (MDAT)
timeFrame: From study day 3 to study day 17 (2 weeks)
measure: Change in Responsive care and learning opportunities in the home environment: Home Observation for the Measurement of the Environment (HOME) Inventory score
timeFrame: From study day 3 to study day 17 (2 weeks)
Secondary outcomes:
measure: Household-level consumption of salt
timeFrame: Study day 0
measure: Household-level consumption of bouillon
timeFrame: Study day 0
measure: Change in willingness to pay for multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 1 and 17
measure: Themes from focus group discussions
timeFrame: Study day 2 and 17
measure: Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 17
measure: Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
timeFrame: Study day 9
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
affiliation: University of California, Davis
name: Reina Engle-Stone, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ghana
name: Seth Adu-Afarwuah, PhD
role: PRINCIPAL_INVESTIGATOR
References: