Cassava Intervention Project

Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration

Sponsors

Lead Sponsor: Ministry of Public Health, Democratic Republic of the Congo

Collaborator: National Institutes of Health (NIH)
Oregon Health and Science University
Michigan State University
University of Kinshasa
National Institute of Environmental Health Sciences (NIEHS)

Source Ministry of Public Health, Democratic Republic of the Congo
Brief Summary

Investigators will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists.

Detailed Description

The proposed project seeks methods to prevent and elucidate biomarkers of neurocognition and motor deficits associated with chronic dietary reliance on cyanogenic cassava, a staple food crop for more than 600 millions of people living in the tropics. Aim 1 will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists (2 intervention training arms). Aim 2 will determine whether post-intervention reductions in cassava cyanogenic content and child U-SCN are associated with changes in biomarkers of cassava neurotoxicity particularly 8,12-iso-iPF2α-VI isoprostane (oxidant marker), carbamoylated albumin fragments KVPQVSTPTLVEVSR (residues 438-452) and LDELRDEGKASSAK (residues 206-219), or homocitrulline (carbamoylating markers), and scores at the KABC-II cognition and BOT-2 motor testing.

Overall Status Active, not recruiting
Start Date July 30, 2017
Completion Date August 31, 2021
Primary Completion Date June 30, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in food cyanogenic exposure From baseline to 6-month time points
Change in internal cyanogenic exposure From baseline to 6-month time points
Change in oxidation damage From baseline to 6-month time points
Change in carbamoylation From baseline to 6-month time points
Change in carbamoylation surrogate From baseline to 6-month time points
Secondary Outcome
Measure Time Frame
Change in cognition performance From baseline to 6-month time points
Change in motor proficiency From baseline to 6-month time points
Enrollment 1200
Condition
Intervention

Intervention Type: Other

Intervention Name: Non Inferiority WTM Interventional Trial

Description: The intervention will implement the WTM cassava processing technique in participating households. Twenty women (in leading roles) will be our principal candidates to serve as peer trainers. Together with a 20 community health worker specialists, these women will be trained in the WTM technique by the Kinshasa team of community health workers who are experts in the WTM method. Those who master the technique will then be certified as trainers to train and support other small groups of other mothers throughout a two-year period in the implementation of the WTM for the safer processing of food for their families. Both the community health worker specialists and trained women (prospective trainers) would have to be able to bring the cassava cyanogenic content to the lowest achievable level, which must be < 10 ppm as per the recommendations of the World Health Organization.

Eligibility

Criteria:

Inclusion Criteria:

- Households with a konzo child and non-konzo sibling between 5 and 12 years

- Presence of a biological mother primarily responsible for the household food preparation and caring for the children

- Mother consenting to participate in this study

Exclusion Criteria:

- History of seizures

- History of cerebral malaria

- History of retroviral (HIV-HTLV) infections

Gender: All

Minimum Age: 5 Years

Maximum Age: 12 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mumba Ngoyi Study Director Netherlands: Ministry of Health, Welfare and Sports
Location
Facility: INRB
Location Countries

Congo, The Democratic Republic of the

Verification Date

March 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ministry of Public Health, Democratic Republic of the Congo

Investigator Full Name: Desire Tshala-Katumbay

Investigator Title: Head Complex Morbidity Unit

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Peer-led Intervention

Type: Experimental

Description: Peers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.

Label: Specialist-led Intervention

Type: Experimental

Description: Specialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial..

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: We will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (Arm 1 = women training other women in the WTM) with that by community-health worker specialists (Arm 2= specialist led intervention arm)

Primary Purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov