Nutrition, HealthyREFIPRONCT06739629
Refugee Insect Production for Food and Feed: the School Meal Intervention
A study testing Insect porridge and Maize Porridge in people with Nutrition, Healthy, run by University of Copenhagen at 1 site in Uganda.
Trial summary
The goal of this randomized controlled trial is to assess whether edible insect-enriched school porridge has nutrition and health benefits for children aged 6-9 years in refugee communities in Uganda. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Insect porridge and Maize Porridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUganda
- Study dates
- 17 Jun 2024to 25 Oct 2024
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children in Primary 1 in Bukere and Kako primary school
- Age: 6-9 years
- Child can eat insects
- Written informed consent given by parent/caregiver
Who cannot join
- Severe acute malnutrition measured as MUAC < 13.5 cm
- Known allergies related to consuming insects
- Disability that impedes eating capacity
- Disability that makes height assessment problematic
- Family plans to move away or deregister child from Kako and Bukere primary schools within the school term.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The School Meal Intervention: the Effect of Yellow Mealworm-enriched Maize Porridge on Nutrition and Health Status of 6-9-year-old Children
The goal of this randomized controlled trial is to assess whether edible insect-enriched school porridge has nutrition and health benefits for children aged 6-9 years in refugee communities in Uganda.
The main question the research aims to answer is: Does a daily serving of maize porridge enriched with yellow mealworm flour improve the gut health, growth, and micronutrient status of children in comparison to a standard maize porridge?
Participants will:
Consume a daily serving of yellow mealworm porridge or a maize porridge for one school term (3 months). Data is collected before, during and after the intervention period.
- Conditions
- Nutrition, Healthy
- Being tested
- Insect porridge, Maize Porridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insect porridgeOther
Also called Yellow mealworm porridge, Edible insect porridge
Yellow mealworm porridge
Maize PorridgeOther
Also called porridge
Maize porridge
| Study group | Role | What they receive |
|---|---|---|
| Yellow mealworm-enriched porridge | Experimental | Participants receive a daily meal of yellow mealworm-enriched porridge, served in schools. The porridge provides 420 Kcal/serving Receives: Other: Insect porridge |
| Maize porridge | Other | Participants receive a standard maize porridge served in schools. This porridge is comparable to the porridge served in the parent-led school feeding program. Receives: Other: Maize Porridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in linear growth based on absolute height gain over 3 months intervention period
Assessing the effect of the intervention on height gain measured in cm
Measured: 3 months
Secondary outcomes (24)
Change in myeloperoxidase (MPO) over 3 months intervention period
Assessing the effect of the intervention on myeloperoxidase (ng/mL), which is a stool marker for Environmental Enteric Dysfunction (EED). A high value indicates high intestinal inflammation.
Measured: 3 months
Change in alpha-1-anti-trypsin (AAT) over 3 months intervention period
Assessing the effect of the intervention on alpha-1-anti-trypsin (mg/g) which is a stool marker for Enteric Environemtal Dysfunction ( EED). A high value indicates high intestinal protein loss.
Measured: 3 months
Change in in Neopterin (NEO) over the 3 months intervention period
Assessing the effect of the intervention on Neopterin ( nmol/L) which is a stool marker for Enteric Environemtal Dysfunction (EED). A high value indicates intestinal inflammation.
Measured: 3 months
Change in weight over the 3 months intervention period
Assessing the effect of the intervention on weight gain (kg)
Measured: 3 months
Change in BMI- for- age Z-score over 3 months intervention period
Assessing the effect of the intervention on BMI-for-age Z-score, by combining weight (Kg) and Height (m2) to report BMI (kg/m2) using the cut offs: Overweight: >+1SD, Obesity: >+2SD, Thinness: <-2SD, Severe thinness: <-3SD
Measured: 3 months
Change in Height- for-age Z-score over the 3 months intervention period
Assessing the effect of the intervention on height-for-age Z-score values using the cut offs: < -2 to -3 HAZ moderately stunted, HAZ < -3 severely stunted
Measured: 3 months
Change in Weight- for-age Z-score over the 3 months intervention period
Assessing the effect of the intervention on weight-for-age Z-score using the cut offs: -2 to-3 WAZ moderately underweight, WAZ < -3 severely underweight
Measured: 3 months
Change in Mid-Upper Arm Circumference (MUAC) over the 3 months intervention period
Assessing the effect of the intervention on the Mid-Upper Arm Circumference in cm using the cut-offs: <13.5cm severe acute malnutrition, 13.5cm -14.5cm moderate acute malnutrition.
Measured: 3 months
Change in Subscapular and Triceps skinfold thickness over 3 months intervention period
Assessing the effect of the intervention on subscapular and triceps skinfold thickness measured in mm.
Measured: 3 months
Change in waist circumference measurement over 3 months intervention period
Assessing the effect of the intervention on waist circumference measured in cm.
Measured: 3 months
Change in fat mass over the 3 months intervention period
Assessing the effect of the intervention on fat mass measured in kgs using deuterium dilution method and bioimpedance analyzer. Low fat mass indicates healthier body composition.
Measured: 3 months
Change in fat free mass over the 3 months intervention period
Assessing the effect of the intervention on fat free mass measured in kg using deuterium dilution method and bioimpedance analyzer. A high fat free mass indicates high muscle mass and healthier body composition.
Measured: 3 months
Change in fat mass index over the 3 months intervention period
Assessing the effect of the intervention on fat mass index measured in kg/m2, using deuterium dilution method and bioimpedance analyzer. Low fat mass index indicates a healthier body composition.
Measured: 3 months
Change in fat free mass index over 3 months intervention period
Assessing the effect of the intervention on fat free mass index ( FFMI) measured in kg/m2 using deuterium dilution method and bioimpedance analyzer. A high fat free mass index indicates high muscle mass and healthier body composition
Measured: 3 months
Change in C- reactive protein (CRP) over the 3 months intervention period
Assessing the effect of the intervention on C-reactive Protein(mg/L) which is a blood marker for systemic inflammation. High CRP values indicate systemic inflammation.
Measured: 3 months
Change in alpha-1-acid glycoprotein (AGP) over the 3 months intervention period
Assessing the effect of the intervention on alpha-1-acid glycoprotein (g/L) which is a blood marker for systemic inflammation. High AGP values indicate systemic inflammation.
Measured: 3 months
Change in insulin like growth factor (IGF-1) over the 3 months intervention period
Assessing the effect of the intervention on insulin like growth factor (ng/mL) which is a blood markers for growth. High IGF-1 values support growth.
Measured: 3 months
Change in hemoglobin over the 3 months intervention period
Assessing the effect of the intervention on hemoglobin measured in g/dL. Low hemoglobin levels indicate Anemia.
Measured: 3 months
Change in ferritin over the 3 months intervention period
Assessing the effect of the intervention on serum ferritin measured in μg/L. A low level of serum ferritin indicates Anemia.
Measured: 3 months
Change in soluble transferrin receptor (sTfR) over the 3 months intervention period
Assessing the effect of the intervention on soluble transferrin receptor measured in mg/L. A high level of sTfR is associated with Anemia.
Measured: 3 months
Change in cobalamin over the 3 months intervention period
Assessing the effect of the intervention on cobalamin measured in pmol/L. A low level of cobalamin is associated with Vitamin B12 deficiency.
Measured: 3 months
Change in retinol binding protein (RBP) over the 3 months intervention period
Assessing the effect of the intervention on serum retinol binding protein (RBP) measured in µmol/l. A low level of RBP is associated with Vitamin A deficiency.
Measured: 3 months
Change in methyl malonic acid (MMA) over the 3 months intervention period
Assessing the effect of the intervention on methyl malonic acid (MMA) measured in nmol/L. A high level of MMA indicates Vitamin B12 deficiency.
Measured: 3 months
Change in citrulline over the 3 months intervention period
Assessing the effect of the intervention on plasma citrulline measured in μmol/L. A low level of citrulline indicates impaired intestinal function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start17 Jun 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Two-arm randomized intervention
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, International Centre of Insect Physiology and Ecology (ICIPE), Mothers Against Malnutrition and Hunger, Child and Family Health, Uganda, Research and Action for Income Security
- Responsible party
- Sponsor
- Investigators
- Ezekiel Mupere, PhD, MD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739629
- Sponsor's protocol ID
- S400- REFIPRO STUDY
- Acronym
- REFIPRO
- Status last verified
- Dec 2024
- First submitted
- 22 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The School Meal Intervention: the Effect of Yellow Mealworm-enriched Maize Porridge on Nutrition and Health Status of 6-9-year-old Children
- ClinicalTrials.gov ID
- NCT06739629
- Acronym / sponsor ID
- REFIPRO / S400- REFIPRO STUDY
- Conditions
- Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Makerere University, International Centre of Insect Physiology and Ecology (ICIPE), Mothers Against Malnutrition and Hunger, Child and Family Health, Uganda, Research and Action for Income Security
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 18 Dec 2024 (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.
The goal of this randomized controlled trial is to assess whether edible insect-enriched school porridge has nutrition and health benefits for children aged 6-9 years in refugee communities in Uganda.
The main question the research aims to answer is: Does a daily serving of maize porridge enriched with yellow mealworm flour improve the gut health, growth, and micronutrient status of children in comparison to a standard maize porridge?
Participants will:
Consume a daily serving of yellow mealworm porridge or a maize porridge for one school term (3 months). Data is collected before, during and after the intervention period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized intervention
| Arm | Type | Receives |
|---|---|---|
| Yellow mealworm-enriched porridge | Experimental | Other: Insect porridgeParticipants receive a daily meal of yellow mealworm-enriched porridge, served in schools. The porridge provides 420 Kcal/serving |
| Maize porridge | Other | Other: Maize PorridgeParticipants receive a standard maize porridge served in schools. This porridge is comparable to the porridge served in the parent-led school feeding program. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children in Primary 1 in Bukere and Kako primary school
- Age: 6-9 years
- Child can eat insects
- Written informed consent given by parent/caregiver
Key exclusion criteria (5 listed)
- Severe acute malnutrition measured as MUAC < 13.5 cm
- Known allergies related to consuming insects
- Disability that impedes eating capacity
- Disability that makes height assessment problematic
- Family plans to move away or deregister child from Kako and Bukere primary schools within the school term.
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 |
|---|---|---|
| Insect porridgeAlso: Yellow mealworm porridge, Edible insect porridgeYellow mealworm porridge | Other | Yellow mealworm-enriched porridge |
| Maize PorridgeAlso: porridgeMaize porridge | Other | Maize porridge |
Primary outcome
Change in linear growth based on absolute height gain over 3 months intervention period
Time frame: 3 months
Assessing the effect of the intervention on height gain measured in cm
24 secondary outcomes
Change in myeloperoxidase (MPO) over 3 months intervention period
Time frame: 3 months
Change in alpha-1-anti-trypsin (AAT) over 3 months intervention period
Time frame: 3 months
Change in in Neopterin (NEO) over the 3 months intervention period
Time frame: 3 months
Change in weight over the 3 months intervention period
Time frame: 3 months
Change in BMI- for- age Z-score over 3 months intervention period
Time frame: 3 months
Change in Height- for-age Z-score over the 3 months intervention period
Time frame: 3 months
Change in Weight- for-age Z-score over the 3 months intervention period
Time frame: 3 months
Change in Mid-Upper Arm Circumference (MUAC) over the 3 months intervention period
Time frame: 3 months
Change in Subscapular and Triceps skinfold thickness over 3 months intervention period
Time frame: 3 months
Change in waist circumference measurement over 3 months intervention period
Time frame: 3 months
Change in fat mass over the 3 months intervention period
Time frame: 3 months
Change in fat free mass over the 3 months intervention period
Time frame: 3 months
Change in fat mass index over the 3 months intervention period
Time frame: 3 months
Change in fat free mass index over 3 months intervention period
Time frame: 3 months
Change in C- reactive protein (CRP) over the 3 months intervention period
Time frame: 3 months
Change in alpha-1-acid glycoprotein (AGP) over the 3 months intervention period
Time frame: 3 months
Change in insulin like growth factor (IGF-1) over the 3 months intervention period
Time frame: 3 months
Change in hemoglobin over the 3 months intervention period
Time frame: 3 months
Change in ferritin over the 3 months intervention period
Time frame: 3 months
Change in soluble transferrin receptor (sTfR) over the 3 months intervention period
Time frame: 3 months
Change in cobalamin over the 3 months intervention period
Time frame: 3 months
Change in retinol binding protein (RBP) over the 3 months intervention period
Time frame: 3 months
Change in methyl malonic acid (MMA) over the 3 months intervention period
Time frame: 3 months
Change in citrulline over the 3 months intervention period
Time frame: 3 months
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Ezekiel Mupere, PhD, MD principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insect porridge and Maize Porridge in people with Nutrition, Healthy, run by University of Copenhagen at 1 site in Uganda.
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 4 inclusion and 5 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 27 Dec 2024. 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 Uganda. 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. 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?
Change in linear growth based on absolute height gain over 3 months intervention period (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.