A preliminary placebo controlled randomized clinical trial to evaluate the effect of the consumption of Sri Lankan black tea on blood lipid levels in patients with dyslipidemia

Effect of the consumption of Sri Lankan black tea on blood lipids: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2025/041

Enrollment

Unknown

Registered

2025-10-10

Start date

2025-10-15

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

Dyslipidemia

Interventions

Study Setting National Institute of Fundamental Studies (NIFS), Kandy Sri Lanka, in collaboration with the Tea Research Institute of Sri Lanka who will be involved in the selection of tea samples, pre

Base Hospital Wathupitiwala and physician-led private clinics in Galle, Gampaha and Kandy districts. A total of 70 patients with marginally high blood lipid levels will be recruited. All eligible par

Eligibility

Inclusion criteria

Inclusion criteria: 1. Individuals aged 20 to 75 years both male and female 2. Dyslipidemia diagnosed through a fasting lipid profile (defined as LDL-C 130–189 mg/dL, TG 150-499 mg/dL, total cholesterol >200 (LDL <190 or TG <500) without additional comorbidities or cardiovascular risk factors ( <20%WHO CVS risk score) (This category do not warrant pharmacological interventions but only lifestyle modification as the management).

Exclusion criteria

Exclusion criteria: 1. Present and past history of diabetes mellitus, cardiovascular disease, chronic kidney disease, hypothyroidism, or chronic inflammatory conditions. 2. Primary hypercholesterolemia falling into a category that requires pharmacological treatment to reduce cholesterol levels (LDL-C >190 mg/dL; increased 10-year risk of atherosclerotic cardiovascular disease). 3. Currently on pharmacological treatment for dyslipidemia management. 4. Pregnant and breast feeding mothers

Design outcomes

Primary

Measure	Time frame
Total cholesterol, triglyceride, HDL, LDL, VLDL, Total cholesterol /HDL ratio and LDL/HDL ratio) HDL- High-Density Lipoprotein LDL- Low-density lipoprotein VLDL- Very-low-density lipoprotein Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Liver function -ALT- Alanine aminotransferase AST- Aspartate Aminotransferase Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Renal function -serum creatinine Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Fasting plasma glucose concentration Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Blood pressure Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ]	—

Measure

Time frame

Total cholesterol, triglyceride, HDL, LDL, VLDL, Total cholesterol /HDL ratio and LDL/HDL ratio) HDL- High-Density Lipoprotein LDL- Low-density lipoprotein VLDL- Very-low-density lipoprotein Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Liver function -ALT- Alanine aminotransferase AST- Aspartate Aminotransferase Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Renal function -serum creatinine Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Fasting plasma glucose concentration Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ] Blood pressure Mean change - The change in absolute value from baseline Percentage change from baseline [ At baseline, 3rd month and 6th month ]

—

Secondary

Measure	Time frame
Change in anthropometric variables (Height, weight, BMI) [Baseline and at the end of 6 months ]	—

Countries

Sri Lanka

Contacts

Public ContactK. G. Nelum P. Piyasena (PhD)

Research Fellow

nelum.pi@nifs.ac.lk081 223 2002

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 10, 2026