A Clinical trail to see the effect of Probiotics and Docosahexaneoic Acid on learning ability, memory and behavior in Children Aged 7–13 Years
- Conditions
- Apparently Healthy children of age 7-13 years of age
- Registration Number
- CTRI/2016/12/007537
- Lead Sponsor
- Department of Health Research
- Brief Summary
Normal cognitive abilities like attention, concentration and memory are essential factors which directly or indirectly determine the scholastic and overall achievements of an individual not only in terms of schooling, but also in their earning capacity and therefore GDP and economic growth of the country. Intestinal microbiota is increasingly recognized as a complex signaling network which has critical role in cognitive functions including learning, memory and decision making processes. A novel recent study implicated the vagus nerve in the direct communication observed between the gut bacteria and the brain (Bravo J A. et al., 2011). Studies have shown that probiotics improve memory, mood and cognition (Logan and Katzman, 2005, D Benton 2007).
Docosahexaneoic Acid (DHA) is considered as “essential nutrient†both for children and adults, it is a key structural and physiologically active component of the brain, retina and neurons. Dietary intake of DHA, in most parts of the world, falls short of international recommendations (J. T. Winkler 2013). The supplementation of DHA in the diet modulates neurotransmission, gene expression and signal transduction improvements. Proposed study will address weather combination of both probiotic and DHA supplementation will improve cognition, concentration, memory and behavior in children 7-9 years of age. Supplementing DHA and probiotic will also help in other health benefits as these are known anti- inflammatory, immunomodulater and improve mineral absorption. This study will provide evidence base for the role of dietary supplements in enhancing cognition (student performance) which intern helps to earn more and improves GDP and economic growth of the country. This could lead to a more systematic approach to raising achievement and improving behavior in mainstream schools by early intervention.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 840
Healthy children, aged 7–13 years from Government/Private school who are willing to be involved in this study will be included.
- Children with specific medical disorders (e.g. visual or hearing impairment), general learning difficulties will be excluded from the study.
- Children who are eating fish > twice week and already taking Omega-3 will be excluded.
- Children who are taking medicines expected to affect behavior and learning.
- Children who’s sibling will be in study.
- Children with allergies to lactose will be excluded as probiotic capsule contains small amounts of lactose or skim milk product.
- Children with weakened or compromised immune systems will be excluded.
- Children will be excluded whose social/family circumstances would have made inclusion into the study inappropriate (e.g. serious illness in the family).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in cognition, concentration, memory and behaviour in children aged 7-13 years. Baseline to Endpoint
- Secondary Outcome Measures
Name Time Method •The study will show if effects of treatment on behaviour or cognition are mediated by change in child sleep and bowel movements? •Will DHA or related fatty acids (assess objectively in blood sample) predict their learning, behaviour or sleep
Trial Locations
- Locations (1)
Government Primary schools in and around Secunderabad and Hyderabad.
🇮🇳Hyderabad, ANDHRA PRADESH, India
Government Primary schools in and around Secunderabad and Hyderabad.🇮🇳Hyderabad, ANDHRA PRADESH, IndiaDevraj ParasannanavarPrincipal investigator8712136486devraj.jp@rediffmail.com