Main
|
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: |
|
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)
|
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:
|
|
|
|