Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/02/2017
Date assigned
16/03/2017
Last edited
14/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Kenya children aged from six months to five years are usually given porridge in between meals and this usually continues when the children join nursery school. Protein and mineral deficiency is common in Kenyan children and insects have been shown to contain sufficient proteins and minerals when supplemented in complementary food. Cricket rearing is new in Kenya and farmed crickets could be used to improve the nutritional status and gut health of schoolchildren in Kenya. The aim of this study is to assess the acceptance and impact on nutrition of a daily school meal of a cricket-based porridge, to provide information on cricket as an alternative animal protein source which may be cheaper and affordable to many Kenyans and therefore help curb child malnutrition.

Who can participate?
Children aged 3-7 attending Cheptigit nursery school

What does the study involve?
Participating children are given a daily portion of porridge from Monday to Friday for 6 months. The children are randomly allocated to receive either cricket-based porridge, milk-based porridge, or plant-based porridge. The children are assessed for their acceptance of the food with questionnaires. Their height, weight, skinfolds, and mid upper arm circumference are measured. They also provide finger prick blood samples and stool samples.

What are the possible benefits and risks of participating?
Children participating in this study may benefit from the daily porridge and the monthly health checks. They may feel a little pain during the finger prick. There are no other anticipated risks in this study.

Where is the study run from?
Cheptigit nursery school (Kenya)

When is the study starting and how long is it expected to run for?
February 2017 to August 2017

Who is funding the study?
The Consultative Research Committee for Development Research (FFU), Danida, Ministry of Foreign Affairs (Denmark)

Who is the main contact?
1. Dr Nanna Roos (scientific)
nro@nexs.ku.dk
2. Dr John Kinyuru (scientific)
jkinyuru@agr.jkuat.ac.ke
3. Miss Carolyne Kipkoech (public)
kipkoechcarolyne@gmail.com

Trial website

www.greeinsect.ku.dk

Contact information

Type

Scientific

Primary contact

Dr Nanna Roos

ORCID ID

http://orcid.org/0000-0002-9733-9523

Contact details

University of Copenhagen
Department of Nutrition
Exercise and Sports (NEXS)
Rolighedsvej 26
Frederiksberg
1958
Denmark
+45 (0)3532 2497
nro@nexs.ku.dk

Type

Scientific

Additional contact

Dr John Kinyuru

ORCID ID

Contact details

Jomo Kenyatta University of Agriculture and Technology
Department of Food Science and Technology
PO Box 62000
Nairobi
00200
Kenya
+254 (0)723 667 432
jkinyuru@agr.jkuat.ac.ke

Type

Public

Additional contact

Miss Carolyne Kipkoech

ORCID ID

Contact details

Jomo Kenyatta University of Agriculture and Technology
Department of Food Science and Technology
PO Box 62000-002000
Nairobi
00200
Kenya
+254 (0)721 481 324
kipkoechcarolyne@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MKU/ERC/0274

Study information

Scientific title

The impact of edible cricket in a school meal programme on nutritional status, gut microbiota and health in pre-school children (age 3-4 years): an individually randomized, single-blinded controlled trial in Uasin Gishu County, Kenya

Acronym

CRICKFOOD

Study hypothesis

School meal serving with a fortified porridge made with edible insect (cricket) supports growth (linear and weight) at least equal to a positive control group receiving a fortified porridge with milk powder, and better than a negative control of a fully plant based fortified porridge.

Ethics approval

Mount Kenya University Ethical Review Committee, 09/01/2017, ref: MKU/ERC/0274

Study design

Individually randomized single-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

No participant information sheet available. Parents received oral information and signed a consent form

Condition

Nutrition

Intervention

The intervention will involve feeding children in a school setup. The children in the pre primary section will be given porridge every five days in a week. Treatment is a daily food supplement served as a school meal. Children will be randomly allocated (simple randomization) to be given 65 grams of either milk based, cricket based or cereal based flour in form of porridge:
1. Intervention: a fortified porridge with edible insects (cricket)
2. Positive control: a similarly fortified porridge with milk powder
3. Negative control: a fortified plant-based porridge
The food groups are blinded for investigators, while food group cannot be blinded to participants due to different appearance and taste. Children will be served porridge every day from Monday to Friday while at school for a period of six months. The children will line up for porridge depending on their trial arm and then they will be served and observed as they take the porridge and any remaining volume recorded.

There will be baseline measures and dietary intake questionnaires at the beginning and at the end of the trial, with baseline and end line measures of stool, hemoglobin through finger prick, fatty acid analysis, weight, height, and mid upper arm circumference. Every month the children will undergo morbidity checks, weight, height, and mid upper arm circumference measures.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

Weight for Height (Z score), measured using Seca digital weight measuring scale at 1,2, 3, 4, 5 and 6 months

Secondary outcome measures

1. Porridge acceptability, measured daily using amount of porridge consumed assessed by weighing any remaining quantity of the porridge at the end of the meal
2. School attendance, measured daily using school registration of each child
3. Stool microbiota, analysed using a stool sample at baseline and endline (6 months)
4. EED (Environmental Enteric Dysfunction) prevalence, measured using a stool sample (indicators to be assessed: myeloperoxidase and neopterin) at baseline and endline (6 months)

Overall trial start date

14/02/2017

Overall trial end date

14/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children attending Cheptigit nursery school
2. Weight for Height (WHZ) – ≥-3 Z scores
3. Caregivers who will accept that their children participate in the study and sign the consent form
4. Children who are willing to take porridge and follow the study procedure and therefore assent to the study procedure
5. Age 3-7 years

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

135

Participant exclusion criteria

1. Weight for Height (WHZ) ≤ 3 Z scores
2. Children allergic to any ingredients in the porridge
3. Children whose parents do not consent to the study
4. Children with obvious signs of disease

Recruitment start date

10/03/2017

Recruitment end date

30/03/2017

Locations

Countries of recruitment

Kenya

Trial participating centre

Cheptigit nursery school
00200
Kenya

Sponsor information

Organisation

University of Copenhagen

Sponsor details

Department of Nutrition
Exercise and Sports
Rolighedsvej 26
Frederiksberg
1958
Denmark
+45 (0)3532 2497
nro@nexs.ku.dk

Sponsor type

University/education

Website

http://nexs.ku.dk/english/

Organisation

Jomo Kenyatta University of Agriculture and Technology

Sponsor details

Department of Food Science and Technology
PO Box 62000
Nairobi
00200
Kenya
+254 (0)67 587 0001
info@jkuat.ac.ke

Sponsor type

University/education

Website

http://www.jkuat.ac.ke/contacts/

Funders

Funder type

Government

Funder name

The Consultative Research Committee for Development Research (FFU), Danida, Ministry of Foreign Affairs, Denmark. Funded under the grant for the project 'GREEiNSECT - insects for green economy' (www.greeinsect.ku.dk)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal, to be submitted November 2017

IPD sharing plans
This study is collaborative research between John Kinyuru, Jomo Kenyetta University of Agriculture and Tecnology (JKUAT), Nairobi, Kenya (jkinyuru@agr.jkuat.ac.ke) and Nanna Roos, University of Copenhagen, Denmark (nro@nexs.ku.dk). Request for access to dataset should be sent jointly to these collaborating partners.

Intention to publish date

01/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes