Sin Lek Rice
Research Objectives
We are conducting a pilot study using a non-randomized, crossover clinical trial of Sin Lek rice versus traditional white rice consumption in elementary school children in Chiang Rai, Thailand.
Outcomes related to diet, anthropological factors, cognitive function (e.g., short-term working memory, attention, impulsivity), and gut microbial populations are measured at baseline and over a period of 71 weeks.
Diet
Anthropological factors
Cognitive function
Gut microbial population
Our Hypothesis
Why this research is important
Thailand has struggled with malnutrition rates in young children
Rice is a key component of Southeast Asian diets
A whole grain rice varietal (Sin Lek) may support improved nutrition
Procedures
School students will be recruited by the research coordinator at their school. Prior to the beginning of the study the research coordinator will work with the school to host 2 to 3 informational sessions with parents to describe the study and verbally walk through the informed consent form. If parents agree to have their child participate in the study they will be asked to sign the written consent form prior to leaving the information session. Children whose parents do not attend one of the information sessions will be sent a written description of the study together with a consent form, and the research coordinator will attempt to visit each parent in person to discuss the study and determine if they consent for their child to participate. Parents will be queried at multiple time points during the informational sessions and the in person visits about questions they may have. The information sheet, video and consent form will be very clear in stating that participation in the trial in no way impacts a student’s ability to receive lunch, or the attention they receive at school. Recruitment and consenting will occur during the month of October in order to begin the study with all consented students in November. An additional information sheet will be sent to parents at the beginning of the cross-over phase (July) to remind them of the study and that their child will be switching treatment groups.
Measurements
At study start (November 2018), the end of treatment period 1 (week 20), the beginning of treatment period 2 (week 32) and the end of treatment period 2 (week 52) all consented students will undergo an assessment including:
• weight,
• height,
• age,
• school performance and attendance (using school report card system and number of school days missed in prior year due to illness),
• diet (using a one week Thai standardized diet recall assessment),
• two validated neuro-cognitive assessments (Psychomotor Vigilance Task (PVT) 19,24,25and the Corsi Block test 26)
completed using the online Let’s Get Healthy! platform in Thai (eIRB #3694),
• adverse event questionnaire
• provide a stool sample for microbiome analysis (DNA using a quantitative approach).
Recruitment & Privacy
Because this study involves children, the recruitment process and privacy of these children are vital to the success of the study. We are following these guidelines to ensure the privacy of the children involved in the study.
Informational Sessions
Prior to consent, researchers will work with the school to host 2 to 3 informational session to walk parents through the study.
Parental Permission Required
This permission will happen outside of the school to ensure the anonymity of the students that are participating.
Intervention
All students, regardless of consent will receive sin lek or traditional rice at no cost for their daily lunch.
Unique IDs Used
To protect student privacy, the study will not use their name, but rather a unique ID assigned to them at the beginning of the study.
All Data is Secured
All data a specimens will be stored on a secured, password-protected server behind the institutional firewall at MFLU.
Initial Findings
At baseline, females had higher short-term working memory than males. Differences in attention and impulsivity were observed based on feeding method at the time of birth. Diet and cognitive function were not related at baseline.
Eleven bacterial taxa and total bacteria were measured and revealed gut microbiota associations with dietary behavior and anthropology.
Ongoing analyses are exploring the relationship between microbial composition and cognitive outcomes.
Our study was effective at measuring diet, cognitive function, and microbiome outcomes among Thai school children.
Sin Lek rice was accepted by Thai school children.
Preliminary results highlight relationships between dietary habits and gut microbiome composition at baseline.
Further analyses are needed to examine the contribution of the rice intervention on cognitive function and gut microbial composition.
Disclosure
Because this study involves children, the recruitment process and privacy of these children are vital to the success of the study. We are following these guidelines to ensure the privacy of the children involved in the study.
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