NCT03157336

Cassava Intervention Project

Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Ministry of Public Health, Democratic Republic of the Congo · Other Government
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurotoxicity Syndrome, Cassava
• Neurotoxicity Syndrome, Cyanate
• Neurotoxicity Syndrome, Cyanide
• Neurotoxicity Syndrome, Thiocyanate

Interventions

Type	Name	Description
OTHER	Non Inferiority WTM Interventional Trial	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.

Timeline

• Start date: 2017-07-30
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2017-05-17
• Last updated: 2022-06-06

Locations

1 site across 1 country: Democratic Republic of the Congo