AzTrials
AzTrials

Nutrition StatusHEALTHYNSECTNCT06002620

Healthynsect Child Growth and Health Intervention Study

A study testing CSB+, Enriched nutrition food (CEF) and Nutrition education in people with Nutrition Status, run by University of Copenhagen at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Malnutrition in all its forms is still a problem in resource limited settings including Kenya driven by low diet quality, food preparation and feeding practices including hygiene. Read more about this study

Who is it for?
Ages 6 to 7 monthsHealthy volunteers can take part
Conditions the study is for
Nutrition Status
What is being tested?
CSB+, Enriched nutrition food (CEF) and Nutrition education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteKenya
Study dates
9 Mar 2023to 16 Jan 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 7 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged 6 months at the time of enrolment,
  • Hemoglobin (Hb) of ≥7 g/dl (not severely anemic) and
  • Height for Age (HAZ) ≥-3 Z scores (not severely stunted).

Who cannot join

  • Those obviously ill and need medical attention who are referred for care as per ministry of health protocol
  • Children strictly fed on formula feed with no breast feeding
  • Infants whose caregivers do not consent or don't commit to adhere to the feeding regimen prescribed

Trial locations and contacts

1 site in 1 country.

Kenya1 site

  • Rwambwa Sub County Hospital

    Siaya, Western, 40600

Other trials in Kenya

About this study

Official title: Effect of Cricket Enriched Porridge and Nutrition Education on Stunting, Gut Health and Breastmilk Intake of Infants and Young Children in Western Kenya

Malnutrition in all its forms is still a problem in resource limited settings including Kenya driven by low diet quality, food preparation and feeding practices including hygiene. Edible insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Among the insects of preference are the crickets which have been shown to encourage the growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Despite the nutritional value of insects and the contribution of cricket to improved gut health, there is limited evidence on the benefit of cricket based complementary food in the reduction of stunting amongst infants and young children. This study aim to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting) and gut health in Alego Usonga Sub-County in Siaya County of rural western part of Kenya.

Read the detailed description

Malnutrition in all its forms is still prevalent in resource limited settings driven by low diet quality, food preparation and feeding practices including hygiene. Untreated early childhood malnutrition deprives the child from living to full potential, by increasing susceptibility to childhood infections and is life threatening. Insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Crickets positively support growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Single nutrition interventions are confirmed to be less effective in reducing malnutrition and stunting in particular, with a combination of nutrition-specific and nutrition-sensitive interventions yielding better outcome. In spite of recognizing nutritional value of insects and the contribution of cricket to improved gut health, there is limited evidence on the benefit of cricket based complementary food in reducing stunting amongst infants and young children. This study aims to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting status) and gut health in rural Kenya; Alego Usonga Sub-County in Siaya County. The study is based on a 2x2 factorial design among infants aged 6 months and target to assess the main and combined effect of the two interventions (nutrition education and cricket enriched porridge) on the infant and young child's stunting and gut health. The study has four arms namely: Control arm (CA) where the study participants receive the standard care comprising of the supercereal Corn Soy Blend Plus (CSB+) in amounts adjusted for age, Enriched nutrition arm (ENA) where they receive the improved complementary food enriched with cricket and optimized for all the benefits of the cricket in amounts adjusted for age, Nutrition education arm (NEdA) where they receive nutrition education and a Combined Nutrition Education and enriched nutrition (CEdNA). The required sample size (based on the following parameters: Number of groups: = 4, effect size = 0.2, significance level = 0.05, power of test = 80%) is 70 study participants per study arm yielding a total of 280.

Being tested
CSB+, Enriched nutrition food (CEF), Nutrition education, Combined nutrition and education
Keywords
cricket, insect, complementary feeding, gut health, breastmilk intake, 13C sucrose breath test, deuterium oxide, stable isotopes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSB+Dietary supplement

    Also called Standard care

    standard care

  • Enriched nutrition food (CEF)Dietary supplement

    enriched cricket flour at 20%

  • Nutrition educationBehavioural

    regular videos, sms reminders and face to face interaction

  • Combined nutrition and educationCombination product

    combined enriched cricket flour and nutrition education

Study groups in NCT06002620
Study groupRoleWhat they receive
Control arm (CA)ExperimentalA positive control group using an existing nutritional intervention with the known effect will be adopted, so as to meet ethical practice and be able to determine the effect of our new intervention response on the experimental group. The study will use double blinded approach with the control group receiving standard known flour of the supercereal CSB+ adjusted for ages as follows:6-8 months infants receiving 31g daily,9-11 months receiving 47g and 12-24 months receiving 86g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.
Receives: Dietary Supplement: CSB+
Enriched nutrition arm (ENA)ExperimentalThe study will use a Cricket Enriched flour(CEF) - with 20% cricket (, maize, millet, mineral and vitamin premix with amounts served adjusted to ages as:6-8 months infants receiving 29g daily,9-11 months receiving 44g and 12-24 months receiving 80g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.
Receives: Dietary Supplement: Enriched nutrition food (CEF)
Nutrition education arm (NEdA)ExperimentalCombines the control and nutrition education where nutrition education comprises of a video, face to face session and SMS reminder in predetermined regular sessions
Receives: Dietary Supplement: CSB+; Behavioral: Nutrition education
Combined Nutrition Education and enriched nutrition (CEdNA)ExperimentalCombines the Cricket Enriched flour(CEF) and Nutrition education
Receives: Dietary Supplement: Enriched nutrition food (CEF); Combination Product: Combined nutrition and education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stunting (Height/Length for age Z scores)

    Children who are too short for their age according to WHO 2005 growth standards. Length/Height in cm and age in months will be converted to Z scores using WHO Anthro and the values used to categorize growth as per the WHO 2005 standards

    Measured: 8 months

Secondary outcomes (2)

  1. Gut health

    the integrity of the gut measured from stool illustrated by the gut microbiota(microbiome),Myeloperoxidase enzyme levels(MPO) as indicator of tissue inflammation plus butyrate concentration, alpha-1-anti trypsin (ATT) and Neopterin (NEO) \& and 13C stable isotope breath test measured by the time it takes to recover 50% of the stable isotope and also the amount of carbon dioxide produced in the first 90 minutes after the dose with the 13Carbon stable isotope

    Measured: Baseline

  2. Dietary intake

    Total dietary intake including breast milk intake measured by deuterium oxide technique

    Measured: Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start9 Mar 2023
  3. Primary completion16 Jan 2024
  4. Study completion16 Jan 2024

Resources

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
Prevention
Allocation
Randomised
Intervention model
Factorial
Model description
The study has four arms namely: Control arm (CA), Enriched nutrition arm (ENA), Nutrition education arm (NEdA) and a Combined Nutrition Education and enriched nutrition (CEdNA). Cricket Enriched flour(CEF) - with cricket, maize, millet, mineral and vitamin premix Corn-Soy Blend plus(CSB+) - with mineral and vitamin premix Nutrition Education- with video, face to face session and SMS reminder
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002620
Sponsor's protocol ID
WP2 HEALTHYNSECT
Acronym
HEALTHYNSECT
Status last verified
Aug 2023
First submitted
10 Jul 2023
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Okeyo NO, Wille CE, Kiiru SM, Sigot AJ, Ng'ang'a J, Kinyuru J, Roos N, Konyole SO. Effect of Edible Cricket Enriched Complementary Porridge and Nutrition Education on Linear Growth of Children 6-14 Months in Siaya County, Kenya: A Randomized 2 x 2 Factorial Trial. Matern Child Nutr. 2026 Mar;22(1):e70156. doi: 10.1111/mcn.70156.

    PubMed 41503750

Questions about this trial

What is this clinical trial studying?

A study testing CSB+, Enriched nutrition food (CEF) and Nutrition education in people with Nutrition Status, run by University of Copenhagen at 1 site in Kenya.

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 3 inclusion and 3 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 26 Nov 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 Kenya. 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?

Stunting (Height/Length for age Z scores) (time frame: 8 months). 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 NCT06002620, 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 26 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in