Project: Smart Children’s Nutritional Supplements Development
Project Funding Period: May 2017-April 2018
- 3 Global and Regional Specific Supplements Formulation Development and Formulations Testing: $753,000, including Lab work, prototypes and final product formulation.
- 3 Formulations Pilot Test Batch and GRAS Registration: $560,000, including ninety-day toxicology report, FDA filing fee and stability study
- 3 Formulation Clinical Trials [25 Children Studied in Africa and Caribbean for each Formulation]: $1,250,000
The Problem: Severe acute malnutrition (SAM) affects 17 million children under 5 annually and 10-30% of them die. Survivors suffer higher risks of obesity, diabetes and cardiovascular disease and most have poorer cognition, abnormal behavior, underachieve in school and have lower employment status and income. Severe chronic malnutrition affects 161 million annually: these stunted children suffer similar disadvantage. Together severe acute plus severe chronic malnutrition affect one third of children globally. Most live in lower and middle income countries. Malnutrition therefore impairs human development and degrades human capital.
Research has informed rehabilitation strategies for children with SAM by combining special feeds with psychosocial stimulation for best outcomes of body and brain. Yet these feeds provide insufficient specialized lipids to supply the increased demand to rapidly rebuild the shrunken and damaged brains. Hence, while mortality has fallen and brain outcomes improved, neuro-cognition remains significantly impaired. This research project tests the hypothesis that supplementing SAM children with these specialized lipids, which are essential nutrients for the repair of brain, plus psychosocial stimulation will further improve brain outcomes.
SAM children 12-24 months old were tested and treated on a research ward in the main pediatric hospital in Kingston. SAM children are supplemented with long chain polyunsaturated fatty acids found in fish oils or receive usual best care. Supplementation for the roughly 3 months of in-hospital rehabilitation continues after discharge until age 4 years. Both supplemented and un-supplemented children receive psycho-social stimulation. Impact of the supplement is measured at day 14 after patients are stabilized, near discharge at ideal weight for height, 6 months after discharge and at ages 3 and 4 years. Brain function will be tested using well established batteries of developmental, behavioral, and cognitive function. Non-malnourished children in hospital with curable infections that almost always accompany SAM serve as controls and will be followed in the community after discharge and share the same measurements. Cheek cells and white blood cells will be examined to provide further insights into mechanisms underlying the effects of the supplement, and the control systems for genes by measuring DNA methylation differences. Other countries will build local capacity to conduct large scale trials of this supplement in years 1-2 of the grant; and will conduct the supplementation trial in years 3-5.
The Nutritional Requirements Science for a Child’s Brain Function:
A Child’s Brain structural composition is made up of many cells, including neurons and glial cells. The cells support the development of memory, cognition, mental energy, focus, and concentration. Maintaining structural integrity includes keeping Brain cells healthy: ensuring cell walls remain fluid so that they can effectively regulate nutrients coming in and waste going out, and supporting signal-transmitting chemicals in the Children Nutritional Supplement called neurotransmitters. To facilitate these nutrients into the human body, the actives must survive the GI tract and be absorbed from the GI tract as they must reach the Children Nutritional Supplement by crossing the blood-brain barrier.
Phosphatidylcholine is a ubiquitous, naturally occurring phospholipid molecule that incorporate choline as a major part of their structure. It is the major lipid, or fat, of cell membranes and blood proteins. Also, known as PC, phosphatidylcholine serves as the body’s main source of choline, an essential nutrient and precursor to the neurotransmitter, acetylcholine. It makes up a large part of the volume of your brain cells and is incorporated into all your neuron cell membranes. Unfortunately, humans do not get enough of this vital nutrient in their diet which is why using supplements like Phosphatidylcholine is important. Our formulation seeks to stimulate brain growth and replenish brain density through a series of stimulant and nutrient technologies including use of Cytidine 5-diphosphocholine (also known as citicoline or CDP-choline) is an intermediate compound that occurs when choline converts to Phosphatidylcholine.
Contributors Background for Tax Credit Purposes: Individuals and Groups are asked to contribute via the Health Information and Technology Institute (HIT-Institute) with EIN 20-3087510 which was founded in 2006 and continues to be a 501(c)(3) Non-Profit Institute with contributions denoted to be for the “Smart Children’s Fund”.