NCT05872061

Brief Summary

The overall hypotheses is that a product designed with optimized nutritional characteristics, based on consumer preferences and leveraging local nutrient dense ingredients, can successfully deliver nutrition through sustainable market-driven approaches. The objectives of this study were 1) to assess the nutritional adequacy of urban Senegalese households with children and 2) to determine the market potential of a locally sourced and manufactured, blended fortified, cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months. This study simulates a market study, the investigators will conduct a product launch, determine market potential based on sales, evaluate marketing strategy to increase market share, and model the nutritional contribution of FtFF/traditionally fortified product for iron, zinc, and vitamin A. The investigators expect to provide a thorough evaluation of a business-driven strategy (for profit, social enterprise) as a sustainable tool to decrease micronutrient deficiencies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

March 13, 2023

Last Update Submit

May 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assessment of staple intake in urban Senegalese households and children

    A quantitative, modified food frequency questionnaire (FFQ) will be used to assess consumption of various starch rich staples (rice, corn, sorghum, millet, potatoes, cassava) and starch-rich processed foods (bread) for the whole household and children. The caregiver will provide information about the child's amount and frequency of consumption. This will be measured in g/day\*child. The investigators will ask #times/week each staple was consumed as well as the average portion size consumed each time (g).

    10 weeks

  • Assessment of the nutritional adequacy of urban Senegalese households and children

    Nutritional status of children in the household will be assessed using the Food Consumption Score Nutritional Quality Analysis (FCS-N) which was based on country-specific food groups. Food groups are orange fruits, orange vegetables, other fruits, eggs, dairy, organ meats, meat, fish, grains and legumes. Example of food items in the FCS-N assessment will be corroborated by a Senegalese maternal and child health expert. This will be measured in #times/week each food group was consumed.

    10 weeks

Secondary Outcomes (1)

  • Nutritional impact of a fortified cereal-based product for the improvement of micronutrient deficiencies among children aged 24-60 months.

    10 weeks

Interventions

This study will evaluate the market potential of a food-to-food fortified (FtFF) flour.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will collect data about dietary habits for children and the household they lived. Adult caregivers will be approached and provided the relevant information.

You may qualify if:

  • Adults (\>18 years of age), with child(ren) 5 years of age living in the household.

You may not qualify if:

  • No children under 5 y of age living in the household.
  • Not a caregiver for the children in the household.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ITA

Dakar, Senegal

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyVitamin A Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Bruce R Hamaker, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / Distinguished professor

Study Record Dates

First Submitted

March 13, 2023

First Posted

May 24, 2023

Study Start

January 27, 2022

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

No PI was collected. There is not a plan to share participant information.

Locations