Acceptability of Fortified Bouillon Cubes in Northern Ghana

NCT05177614 | Completed

• 2 other identifiers: 1687671017/12/20
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Food, Fortified; Dietary Habits; Child Development

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (6)

• Household-level consumption of salt

  Study day 0

• Household-level consumption of bouillon

  Study day 0

• Change in willingness to pay for multiple micronutrient-fortified bouillon cubes

  Study day 1 and 17

• Themes from focus group discussions

  Study day 2 and 17

• Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes

  Study day 17

Study Arms (3)

Upper-level multiple micronutrient-fortified bouillon cube

EXPERIMENTAL

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

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

Lower-level multiple micronutrient-fortified bouillon cube

EXPERIMENTAL

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

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

Control (iodine-fortified bouillon cube)

PLACEBO COMPARATOR

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

Dietary Supplement: Iodine-fortified bouillon cube

Interventions

Upper-level multiple micronutrient-fortified bouillon cube DIETARY_SUPPLEMENT

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)

Upper-level multiple micronutrient-fortified bouillon cube

Lower-level multiple micronutrient-fortified bouillon cube DIETARY_SUPPLEMENT

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)

Lower-level multiple micronutrient-fortified bouillon cube

Iodine-fortified bouillon cube DIETARY_SUPPLEMENT

30 µg/g Iodine (KIO3)

Control (iodine-fortified bouillon cube)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• years of age (24-71 months)
• residing in the same household as an enrolled woman
• child's primary caregiver signs the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• University of Ghana: collaborator
• Helen Keller International: collaborator

Study Sites (1)

University of Ghana

Accra, Ghana

Location

Related Publications (1)

• Wessells KR, Kumordzie SM, Becher E, Davis JN, Nyaaba KW, Zyba SJ, Arnold CD, Tan X, Vosti SA, Adams KP, Haskell M, Adu-Afarwuah S, Engle-Stone R. Acceptability of Multiple Micronutrient-Fortified Bouillon Cubes among Women and Their Households in 2 Districts in The Northern Region of Ghana. Curr Dev Nutr. 2023 Dec 8;8(1):102056. doi: 10.1016/j.cdnut.2023.102056. eCollection 2024 Jan.

  PMID: 38304733 DERIVED

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Reina Engle-Stone, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Seth Adu-Afarwuah, PhD

  University of Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: January 4, 2022
• Study Start: November 23, 2021
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

GH (1)