Food, FortifiedNCT05177614
Acceptability of Fortified Bouillon Cubes in Northern Ghana
A study testing Upper-level multiple micronutrient-fortified bouillon cube, Lower-level multiple micronutrient-fortified bouillon cube and Iodine-fortified bouillon cube in people with Food, Fortified and Dietary Habits, run by University of California, Davis at 1 site in Ghana.
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… Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food, Fortified, Dietary Habits, Child Development
- What is being tested?
- Upper-level multiple micronutrient-fortified bouillon cube, Lower-level multiple micronutrient-fortified bouillon cube and Iodine-fortified bouillon cube
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGhana
- Study dates
- 23 Nov 2021to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Food, Fortified, Dietary Habits, Child Development
- Being tested
- Upper-level multiple micronutrient-fortified bouillon cube, Lower-level multiple micronutrient-fortified bouillon cube, Iodine-fortified bouillon cube
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper-level multiple micronutrient-fortified bouillon cubeDietary 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)
Lower-level multiple micronutrient-fortified bouillon cubeDietary 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 cubeDietary supplement
30 µg/g Iodine (KIO3)
| Study group | Role | What they receive |
|---|---|---|
| Upper-level multiple micronutrient-fortified bouillon cube | Experimental | 10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients Receives: 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 Receives: 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 Receives: Dietary Supplement: Iodine-fortified bouillon cube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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")
Measured: 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")
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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")
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: From study day 3 to study day 17 (2 weeks)
Secondary outcomes (6)
Household-level consumption of salt
- patterns of salt use prior to the study (pre-intervention)
- assessed at the initial study visit
Measured: Study day 0
Household-level consumption of bouillon
- patterns of bouillon use prior to the study (pre-intervention)
- assessed at the initial study visit
Measured: Study day 0
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
Measured: Study day 1 and 17
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
Measured: Study day 2 and 17
Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes
- post-intervention
- questionnaire to assess perceived positive and negative health effects
Measured: Study day 17
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")
Measured: Study day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start23 Nov 2021
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food, FortifiedStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, Helen Keller International
- Responsible party
- Principal investigator, Reina Engle-Stone, Ph.D, University of California, Davis
- Investigators
- Reina Engle-Stone, PhD, Principal investigator, University of California, DavisSeth Adu-Afarwuah, PhD, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177614
- Sponsor's protocol ID
- 1687671
- Other IDs
- 017/12/20
- Status last verified
- Apr 2022
- First submitted
- 6 Nov 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 38304733
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05177614
- Acronym / sponsor ID
- 1687671
- Conditions
- Food, Fortified, Dietary Habits, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of Ghana, Helen Keller International
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Upper-level multiple micronutrient-fortified bouillon cube | Experimental | Dietary Supplement: Upper-level multiple micronutrient-fortified bouillon cube10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients |
| Lower-level multiple micronutrient-fortified bouillon cube | Experimental | Dietary Supplement: Lower-level multiple micronutrient-fortified bouillon cube10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with six micronutrients |
| Control (iodine-fortified bouillon cube) | Placebo comparator | Dietary Supplement: Iodine-fortified bouillon cube10 gram shrimp-flavoured bouillon cube, consumed ad-lib, fortified with one micronutrient |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- self-reported non-pregnant adult women (15+ years)
- responsible for meal preparation in the household
- signed the informed consent form
- 2-6 years of age (24-71 months)
- residing in the same household as an enrolled woman
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper-level multiple micronutrient-fortified bouillon cube80 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) | Dietary supplement | Upper-level multiple micronutrient-fortified bouillon cube |
| Lower-level multiple micronutrient-fortified bouillon cube28.8 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) | Dietary supplement | Lower-level multiple micronutrient-fortified bouillon cube |
| Iodine-fortified bouillon cube30 µg/g Iodine (KIO3) | Dietary supplement | Control (iodine-fortified bouillon cube) |
Primary outcome
Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked)
Time frame: Study day 1
* 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)
Sensory perceptions of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 or 2
* 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")
Sensory perceptions of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 or 2
* 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")
Ability to discriminate among different multiple micronutrient-fortified bouillon cubes (uncooked)
Time frame: Study day 1
* centre-based * triangle test (ability to identify the odd sample correctly)
Preference test of multiple micronutrient-fortified bouillon cubes (uncooked)
Time frame: Study day 1
* centre-based * preference for the multiple micronutrient-fortified bouillon cubes compared to the iodine-fortified control cube (appearance, feel, smell and taste)
Preference test of a soup dish cooked multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 or 2
* 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
Preference test of a rice-based dish cooked multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 or 2
* 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
Consumption of a soup dish cooked with multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 or 2
* 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)
Consumption of a rice-based dish cooked with multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 or 2
* 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)
Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
Time frame: Study day 17
* 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")
Quantity of study-provided bouillon cubes used
Time frame: Study day 17
* in-home acceptability trial (2 weeks) * number of study-provided bouillon cubes used in household over two week trial period
Study-provided bouillon cube use as a proportion of total bouillon use
Time frame: Study day 17
* 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)
Change in child development scores on the Malawi Developmental Assessment Tool (MDAT)
Time frame: From study day 3 to study day 17 (2 weeks)
* gross motor, fine motor, language, and personal-social scores * measured twice during study to assess test-retest reliability * intraclass correlation coefficient of MDAT
Change in Responsive care and learning opportunities in the home environment: Home Observation for the Measurement of the Environment (HOME) Inventory score
Time frame: From study day 3 to study day 17 (2 weeks)
* measured twice during study to assess test-retest reliability * intraclass correlation coefficient of HOME inventory
6 secondary outcomes
Household-level consumption of salt
Time frame: Study day 0
Household-level consumption of bouillon
Time frame: Study day 0
Change in willingness to pay for multiple micronutrient-fortified bouillon cubes
Time frame: Study day 1 and 17
Themes from focus group discussions
Time frame: Study day 2 and 17
Perceived health effects of using study-provided multiple micronutrient-fortified bouillon cubes
Time frame: Study day 17
Sensory perceptions of dishes cooked with multiple micronutrient-fortified bouillon cubes
Time frame: Study day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Derived from this study: PubMed 38304733Wessells 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reina Engle-Stone, PhD principal investigator
University of California, Davis
Seth Adu-Afarwuah, PhD principal investigator
University of Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper-level multiple micronutrient-fortified bouillon cube, Lower-level multiple micronutrient-fortified bouillon cube and Iodine-fortified bouillon cube in people with Food, Fortified and Dietary Habits, run by University of California, Davis at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory perceptions of multiple micronutrient-fortified bouillon cubes (uncooked) (time frame: Study day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.