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Effect of the consumption of Sri Lankan traditional fermented cooked rice (Diyabath) as an additional meal compared to its non-consumption; on the nutritional, health and immune parameters of women of reproductive age in Sri Lanka.
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SLCTR Registration Number
SLCTR/2024/032
Date of Registration
The date of last modification
Oct 09, 2024
Scientific Title of Trial
Effect of the consumption of Sri Lankan traditional fermented cooked rice (Diyabath) as an additional meal compared to its non-consumption; on the nutritional, health and immune parameters of women of reproductive age in Sri Lanka.
Public Title of Trial
Effect of consumption of Sri Lankan traditional fermented cooked rice ‘diyabath’ compared to its non-consumption; on the gut microbiome, health biomarkers and immune markers of women in Sri Lanka
Disease or Health Condition(s) Studied
Nutrition, health and immune parameters of women of reproductive age
Scientific Acronym
NA
Public Acronym
NA
Brief title
Effect of the 'Diyabath' on the nutritional, health and immune parameters of women of reproductive age in Sri Lanka.
Universal Trial Number
U1111-1311-5382
Any other number(s) assigned to the trial and issuing authority
Protocol 23-121-2.1 issued by Ethics review committee-Faculty of Medicine, University of Colombo
What is the research question being addressed?
What is the effect of consuming ‘diyabath’ (fermented rice) on the improvement on nutritional, health and immune parameters vs non consumption in women of reproductive age in Sri Lanka
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Single blinded : Data analysts
Control
Standard therapy/practice
Assignment
Sequential
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
Study setting: Participants for the study will be obtained from a women’s hostel located in Colombo District. This hostel is located in Malabe (Western province of Sri Lanka), in close proximity to 4 private universities. The hostel managements confirmed that the residents are university students, students who are doing their internship or postgraduate studies, and also graduates who are currently working. Therefore, the selected community is composed of working women and students who are in the age group 20-35years (reproductive age). Since the individuals of the study reside in the same hostel where all three meals are being provided, all of them have similar food intake.
Participation selection: According to the ‘hostel register’ (sampling frame) candidates will be invited and an appointed medical officer will conduct the clinical assessments and a trained person will take the BMI measurements of the candidates. An interviewer administered food frequency and amount questionnaire (FFQ) will be also used at the recruitment stage to get a clear understanding about the usual dietary intake patterns of the eligible participants. This has been developed and validated for a similar study population in Sri Lanka with some modifications to assess frequency of a particular food consumption over one week.
Intervention: The study will be a non-randomized, single-arm, controlled trial, in which the same group of participants will serve as both the control and test groups.
The participant will be evaluated across two phases: An initial non-interventional phase of 10 weeks (control group) followed by an intervention phase of another 10 weeks (test group). During the non-interventional (control) phase, the study participants will be on their usual diet. During the interventional phase (test) the study participants will be given diyabath as a pre-breakfast meal and they will continue their usual diet.
Intervention duration for each participant will be 10 weeks (every other day/3 days per week). 1 cup of prepared 'diyabath' (230g) will be given to the participants as an additional meal, before breakfast, on three alternative days per week for 10 weeks.
Inclusion criteria
• Apparently healthy females • Age of 20-35yrs • They should be residing in the selected study setting (the private women’ hostel-Malabe) • The participants should possess BMI of normal range (18.5 to 24.9kg/m2).
Exclusion criteria
• Pregnant women and lactating mothers • Women with any chronic illness requiring long term medication, severe concurrent infections • Women who are on any nutritional supplementation or those who had any nutritional supplementation within the past two weeks to the commencement of the study. • Individuals with a history of bowel disorders or intolerance to cereal based foods, coconut milk, red onion and dried chili • The individuals who generally consume diyabath or any other fermented rice-based food three times or more per week (based on the FFQ) • Individuals with BMI outside the range of 18.5 to 24.9kg/m2
Primary outcome(s)
|
1.
1.Gut microbiome changes parameters (increase in alpha-diversity, increase in the relative abundance of probiotic strains, and decrease in Firmicutes/bacteriodetes ratio) |
[ *At the commencement of the study-base line of non-intervention (control) period (week 0) *at the end of non-intervention (control) period (week 10) = baseline of the intervention * at the end of intervention (week 10) ] |
|
2.
• Health biomarkers (% changes in hsCRP, FBS, Serum insulin, Serum ferritin, ALT, AST ) |
[ *At the commencement of the study-base line of non-intervention (control) period (week 0) *at the end of non-intervention (control) period (week 10) = baseline of the intervention * at the end of intervention (week 10) ] |
|
3.
Immune markers (Changes in immune markers: evaluated by analysing interleukin-6 (IL-6), IL-10 and cytokines) |
[ *At the commencement of the study-base line of non-intervention (control) period (week 0) *at the end of non-intervention (control) period (week 10) = baseline of the intervention * at the end of intervention (week 10) ] |
Secondary outcome(s)
|
1.
Changes in antioxidant capacity in serum |
[ *At the commencement of the study-base line of non-intervention (control) period (week 0) *at the end of non-intervention (control) period (week 10) = baseline of the intervention * at the end of intervention (week 10) ] |
|
2.
Waist circumference, Hip circumference and BMI |
[ *At the commencement of the study-base line of non-intervention (control) period (week 0) *at the end of non-intervention (control) period (week 10) = baseline of the intervention * at the end of intervention (week 10) ] |
Target number/sample size
40
Countries of recruitment
Sri Lanka
Anticipated start date
2024-10-15
Anticipated end date
2025-03-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Investigator-funded
Regulatory approvals
N/A
Status
Approved
Date of Approval
2024-03-21
Approval number
EC-23-121
Details of Ethics Review Committee
| Name: | Ethics Review Committee Faculty of Medicine University of Colombo |
| Institutional Address: | Faculty of Medicine University of Colombo P O Box 271, Kynsey Road, Colombo 8, Sri Lanka |
| Telephone: | +94-11-2695300 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof Pujitha Wickramasinghe
Senior Professor in Paediatrics/Hony. Consultant Paediatrician
Department of Paediatrics,
Faculty of Medicine,
University of Colombo,
Kynsey Road, Colombo 08.
+94 11 2688748
+94 77 7766595
pujitha@pdt.cmb.ac.lk
Contact Person for Public Queries
Prof Pujitha Wickramasinghe
Senior Professor in Paediatrics/Hony. Consultant Paediatrician
Department of Paediatrics,
Faculty of Medicine,
University of Colombo,
Kynsey Road, Colombo 08.
+94 11 2688748
+94 77 7766595
pujitha@pdt.cmb.ac.lk
Primary study sponsor/organization
Faculty of Medicine, University of Colombo,
No 25 Kynsey Road, Colombo 08
+94112 695 300
info@med.cmb.ac.lk
https://med.cmb.ac.lk/contacts/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
Individual participant data will be available including data dictionaries. All of the individual participant data collected during the trial, after deidentification. Study protocol will be available as a document. Data will be available immediately after being selected to published in an indexed journal, no end date. IPD will be shared with anyone who wishes to access the data for any purpose. Data will be available indefinitely at (link will be provided).
Study protocol available
Yes
Protocol version and date
Version 2.1 (Ref. No: EC-23-121)
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
