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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 24 October 2022
Main ID:  ISRCTN10920322
Date of registration: 16/03/2017
Prospective Registration: No
Primary sponsor: University of Copenhagen
Public title: Edible insects (cricket Acheta domesticus) in school meals for improved nutrition in pre-school children in Kenya
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
Date of first enrolment: 10/03/2017
Target sample size: 135
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN10920322
Study type:  Interventional
Study design:  Individually randomized single-blinded trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Kenya
Contacts
Name: Carolyne    Kipkoech
Address:  Jomo Kenyatta University of Agriculture and Technology Department of Food Science and Technology PO Box 62000-002000 00200 Nairobi Kenya
Telephone: +254 (0)721 481 324
Email: kipkoechcarolyne@gmail.com
Affiliation: 
Name: Nanna    Roos
Address:  University of Copenhagen Department of Nutrition, Exercise and Sports (NEXS) Rolighedsvej 26 1958 Frederiksberg Denmark
Telephone: +45 (0)3532 2497
Email: nro@nexs.ku.dk
Affiliation: 
Key inclusion & exclusion criteria
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

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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Nutrition
Nutritional, Metabolic, Endocrine
Intervention(s)

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

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)
Secondary ID(s)
MKU/ERC/0274
Source(s) of Monetary Support
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)
Secondary Sponsor(s)
Jomo Kenyatta University of Agriculture and Technology
Ethics review
Status:
Approval date:
Contact:
Mount Kenya University Ethical Review Committee, 09/01/2017, ref: MKU/ERC/0274
Results
Results available: Yes
Date Posted:
Date Completed: 14/08/2017
URL:
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