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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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2024/032
Enrollment
40
Registered
2024-10-09
Start date
2024-10-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, health and immune parameters of women of reproductive age

Interventions

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

Sponsors

Faculty of Medicine, University of Colombo,
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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) ] •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) ] 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

MeasureTime frame
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) ] 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) ]

Countries

Sri Lanka

Contacts

Public ContactProf Pujitha Wickramasinghe

Senior Professor in Paediatrics/Hony. Consultant Paediatrician

pujitha@pdt.cmb.ac.lk+94 11 2688748

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026