Acceptability of Fortified Bouillon Cubes in Northern Ghana

University of California (UC) Davis

Status: Completed

Conditions: Dietary Habits; Food, Fortified; Child Development

Treatments: Dietary Supplement: Upper-level multiple micronutrient-fortified bouillon cube; Dietary Supplement: Iodine-fortified bouillon cube; Dietary Supplement: Lower-level multiple micronutrient-fortified bouillon cube

Study type: Interventional

Funder types: Other

Identifiers

NCT05177614

017/12/20 (Other Identifier)

1687671

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 3 patient groups, including a placebo group

Upper-level multiple micronutrient-fortified bouillon cube

Experimental group

Description:

10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients

Treatment:

Dietary Supplement: Upper-level multiple micronutrient-fortified bouillon cube

Lower-level multiple micronutrient-fortified bouillon cube

Experimental group

Description:

10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients

Treatment:

Dietary Supplement: Lower-level multiple micronutrient-fortified bouillon cube

Control (iodine-fortified bouillon cube)

Placebo Comparator group

Description:

10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with one micronutrient

Treatment:

Dietary Supplement: Iodine-fortified bouillon cube