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Effects of a combination supplement containing Lysine, Vitamin C and Zinc on oxidative stress, glycaemic control and formation of Advanced Glycosylation End Products (AGEs) in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial

Effects of a combination supplement containing Lysine, Vitamin C and Zinc on oxidative stress, glycaemic control and formation of Advanced Glycosylation End Products (AGEs) in patients with type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2020/020
Enrollment
Unknown
Registered
2020-10-08
Start date
2020-10-15
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

Diabetes

Interventions

The study will be carried out at Nawaloka Hospital Research and Education Foundation (NHHEF), Nawaloka Hospitals PLC, Colombo, Sri Lanka. Consenting participants meeting inclusion/exclusion criteria

Sponsors

Dr. Jhon Burd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Age between 20-70 years b) Both male and female c) Currently on metformin or sulphonyluria or both (less than or equal to two oral hypoglcaemic agents) for the last 3 months d) HbA1c > 7.5%

Exclusion criteria

Exclusion criteria: a) Patients with allergy to any ingredients of the supplement. b) Alcohol consumption >20g/day. c) Patients with diagnosed Alcoholic Liver Disease, cirrhosis or abnormal baseline liver function tests. d) Patients on insulin therapy. e) Patients with raised baseline serum creatinine level (>1.5mg/dl in males or >1.2 mg/dl in females). f) Lactation, pregnancy or unwillingness to use an effective form of birth control for women of childbearing years. g) Patients with any malignancy. h) Patients with any other unrelated chronic illness. i) Patients with cardiac, liver or respiratory failure. j) Patients on any other vitamin/mineral supplementations or any other weight loss medication. k) Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.

Design outcomes

Primary

MeasureTime frame
Change in HbA1c from baseline in treatment and placebo arms [At baseline End of 3 months End of study (at 6 months)] Change in Fasting Blood Glucose (FBG) from baseline in treatment and placebo arms [At baseline End of 3 months End of study (at 6 months)] Change in formation of Advanced Glycosylation End Products (AGEs) from baseline in treatment and placebo arms [At baseline End of 3 months End of study (at 6 months) ] Change in Oxidative Stress from baseline in treatment and placebo arms [At baseline End of 3 months End of study (at 6 months) ]—

Secondary

MeasureTime frame
Percentage of patients with HbA1c <7.0% in treatment and placebo arms [At baseline End of study (at 6 months)] Percentage of patients with Fasting Blood Glucose (FBG) level < 126 mg/dl in treatment and placebo arms [At baseline End of study (at 6 months)] Change in insulin resistance and Beta-cell function in treatment and placebo arms measured by Homeostatic model assessment [At baseline End of study (at 6 months)] Change in Body Mass Index and other anthropometric parameters (waist circumference, hip circumference, waist-to-hip ratio) in treatment and placebo arms [At baseline End of study (at 6 months)] Change in Blood Pressure (systolic and diastolic) in treatment and placebo arms [At baseline End of study (at 6 months)] Change in the Lipid Profile (Total cholesterol, LDL cholesterol, HDL cholesterol and Triglycerides) in treatment and placebo arms [At baseline End of study (at 6 months)]—

Countries

Sri Lanka

Contacts

Public ContactDr. Ranil Jayawardena

Senior Lecturer

ranil7@gmail.com0112695300

Outcome results

None listed

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