Acceptability of Fortified Bouillon Cubes in Northern Ghana

Child Development Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05177614
• Other study ID #: 1687671
• Secondary ID: 017/12/20
• Status: Completed
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: April 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Dietary Habits
• Food, Fortified

Intervention

Dietary Supplement:
• Upper-level multiple micronutrient-fortified bouillon cube
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)
• Lower-level multiple micronutrient-fortified bouillon cube
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)
• Iodine-fortified bouillon cube
30 µg/g Iodine (KIO3)

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Davis	Helen Keller International, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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	Household-level consumption of salt	patterns of salt use prior to the study (pre-intervention); assessed at the initial study visit	Study day 0
Secondary	Household-level consumption of bouillon	patterns of bouillon use prior to the study (pre-intervention); assessed at the initial study visit	Study day 0
Secondary	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
Secondary	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
Secondary	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
Secondary	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