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| ID | Type | Description | Link |
|---|---|---|---|
| 017/12/20 | Other Identifier | GHS-ERC |
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| Name | Class |
|---|---|
| University of Ghana | OTHER |
| Helen Keller International | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper-level multiple micronutrient-fortified bouillon cube | Experimental | 10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients |
|
| Lower-level multiple micronutrient-fortified bouillon cube | Experimental | 10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients |
|
| Control (iodine-fortified bouillon cube) | Placebo Comparator | 10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with one micronutrient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked) |
| Study day 1 |
| Sensory perceptions of a soup dish cooked with multiple micronutrient-fortified bouillon cubes |
| Study day 1 or 2 |
| Sensory perceptions of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes |
| Study day 1 or 2 |
| Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked) |
| Study day 1 |
| Preference test of multiple micronutrient-fortified bouillon cubes (uncooked) |
| Study day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Household-level consumption of salt |
| Study day 0 |
| Household-level consumption of bouillon |
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Inclusion Criteria:
Acceptability study:
Child development assessment pilot sub-study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reina Engle-Stone, PhD | University of California, Davis | Principal Investigator |
| Seth Adu-Afarwuah, PhD | University of Ghana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ghana | Accra | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38304733 | Derived | 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. |
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The investigators will commit to Global Access. The investigators intend to 1) publish journal articles describing the study results with an Open Access license, 2) make available information about study methods, such as protocols or standard operating procedures, on the study website, and 3) make available de-identified datasets upon request by the study sponsor or other investigators. Material/DataTransfer Agreements will be developed between study collaborators, sponsor, and any organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis Institutional Review Board (IRB) and Ghana Health Services Ethical Review Committee (GHS-ERC). Organizations that may request the data; terms of the agreement will be subject to the data handling and storage procedures approved by the University of California, Davis IRB and GHS-ERC
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| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
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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.
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| 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) |
|
| Iodine-fortified bouillon cube | Dietary Supplement | 30 µg/g Iodine (KIO3) |
|
| Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes |
|
| Study day 1 or 2 |
| Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes |
| Study day 1 or 2 |
| Consumption of a soup dish 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 |
| Study day 1 or 2 |
| Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes |
| Study day 17 |
| Quantity of study-provided bouillon cubes used |
| Study day 17 |
| Study-provided bouillon cube use as a proportion of total bouillon use |
| Study day 17 |
| Change in child development scores on the Malawi Developmental Assessment Tool (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 |
| From study day 3 to study day 17 (2 weeks) |
| 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 |
| Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes |
| Study day 9 |