Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202104533831364 Date of Approval: 13/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ZAZA study
Official scientific title Zinc isotope study: Assessing Zinc Absorption from edible insects in young children
Brief summary describing the background and objectives of the trial Zinc deficiency is estimated to attribute to over 800,000 child deaths per year. Zinc deficiency especially affects children in developing countries where the diet is mainly cereal based. The high prevalence of deficiencies in this group can be related to increased needs during growth and development and a low dietary intake. Strategies to increase the intake of zinc include increasing dietary diversity and home fortification amongst others. Increasing dietary diversity can be achieved by adding locally available and culturally acceptable foods to the diet. Insects are of high nutritional value and a sustainable source of minerals, and therefore an ideal candidate for enriching the diet of these young children. This study will be the first to determine zinc absorption from insects in humans. The main objective is to assess the total absorbed zinc (TAZ) from freeze-dried house crickets added to non-refined maize porridge in comparison with a plain porridge in young children (24-36 months). Secondary objectives consist of: the comparison of the TAZ from freeze-dried house crickets added to non-refined maize porridge to the TAZ from protein powder extracted from crickets and added to non-refined maize porridge. In addition, the TAZ from freeze-dried house crickets added to non-refined maize porridge is compared to the TAZ from ZnSO4 (the best available form) added to non-refined maize porridge.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Nutrition
Anticipated trial start date 31/05/2021
Actual trial start date
Anticipated date of last follow up 09/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Test meal Zn1 1 meal ( consumed within 15-30 minutes) on 1 test day. Test meal 1 will consist of 200 grams of porridge (6% maize flour) prepared with non-refined maize flour mixed with 15-20 g of freeze-dried 67Zn intrinsically labelled crickets (Acheta domesticus). Each test meal will contain ~3 mg of zinc (isotopic enrichment 25%). 32
Experimental Group Test meal Zn3 1 meal ( consumed between 15-30 minutes) on 1 test day. Test meal 3 will consist of 200 grams of porridge (7-8% maize flour) prepared with non-refined maize flour mixed with protein powder extracted from crickets (Acheta domesticus) (15-20 gram of 67Zn intrinsically labelled cricket protein). Each test meal will contain ~3 mg of zinc (isotopic enrichment 25%). 32
Control Group Test meal ZN2 1 meal ( consumed between 15-30 minutes) on 1 test day Test meal 2 will consist of 200 grams of porridge (7-8% maize flour) prepared with non-refined maize flour mixed with ZnSO4 labelled with 0.75 mg of 68Zn and 2.25 mg of unlabeled Zn which will be added as dissolved ZnSO4. Since Zn absorption decreases with a higher amount of Zn in the meal, the amount of ZnSO4 used as an optimal reference in this meal will be closely matched with the measured amount of Zn in Test meal Zn-1 to determine the relative fractional absorption of zinc from the insects. 32 Uncontrolled
Control Group Test meal Zn4 1 meal ( consumed within 15-30 minutes) on 1 test day Test meal 4 will consist of 200 grams of porridge (7-8% maize flour) prepared with non-refined maize flour. To be able to trace the fractional absorbed Zinc from this meal, 0.75 mg of labelled 68Zn will be added as dissolved ZnSO4. This test meal contains the least amount of Zn of the four test meals, and represents the common meal fed to children in this age range. 32 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Apparently healthy young children Age between 24-36 months Willing to consume edible house crickets Not be wasted (weight-for-height z-score >-2) or severely stunted (height-for-age z-score >-3) (WHO 2006 growth standards) Signed informed consent by guardian Having consumed vitamin and mineral supplements <2 weeks before start of the study (including milk formula, MNPs or other nutrient fortified products) Current metabolic, gastrointestinal or chronic diseases (reported by guardians) Taking any long-term medication P. falciparum malaria infection Elevated concentration of C-reactive protein (defined as CRP >5 mg/L) Anaemia (defined as Hb <7g/dl) Known food allergies related to the intervention meals: Allergic to crustaceans; meaning no allergies for amongst others: crabs, lobsters, crayfish, shrimps and prawns. Reported medically prescribed diet Breastfed children (≥1 time per day) Preschool Child: 2 Year-5 Year 24 Month(s) 36 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/02/2021 Kenyatta National Hospital University of Nairobi Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
Nairobi Nairobi 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total absorbed zinc (TAZ) from freeze-dried house crickets added to non-refined maize porridge compared to the TAZ of plain porridge. Endpoint
Secondary Outcome The Total Absorbed Zinc from protein powder extracted from crickets added to a non-refined maize porridge and from a porridge where ZnSO4, the best bioavailable form of Zn, is added. Endpoint
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ober Kamoth Sub County Hospital Kisumu East Kisumu Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust 215 Euston road, Gibbs Building, London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maseno University Kondele Kisumu- Busia road Kisumu Kenya University
COLLABORATORS
Name Street address City Postal code Country
Wageningen University and Research 6708 PB Wageningen Netherlands
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alida Melse Boonstra alida.melse@wur.nl +3137484317 6708 WE
City Postal code Country Position/Affiliation
Wageningen Netherlands Wageningen University
Role Name Email Phone Street address
Public Enquiries Tele Boit tele.boit@wur.nl +31649237602 6708 WE
City Postal code Country Position/Affiliation
Wageningen Netherlands Wageningen University
Role Name Email Phone Street address
Scientific Enquiries Pauline Andango aandango@maseno.ac.ke +254728485729 Kondele Kisumu Busia Road, Maseno
City Postal code Country Position/Affiliation
Kisumu Kenya Maseno University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underline the results reported in this article, after deidentification( text, tables, figures and appendices) Analytic Code,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication. Researchers who provide a methodologically sound proposal. For analysis that achieve aims in the approved proposal. Proposal should be directed to alida.melse@wur.nl. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information