Home » Trials » SLCTR/2020/020
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
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SLCTR Registration Number
SLCTR/2020/020
Date of Registration
The date of last modification
Oct 08, 2020
Scientific Title of 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
Public Title of 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
Disease or Health Condition(s) Studied
Diabetes
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1257-8350
Any other number(s) assigned to the trial and issuing authority
EC-20-035: ERC Colombo
What is the research question being addressed?
Does a combination supplement with Lysine, Vitamin C and Zinc improve oxidative stress, glycaemic control and formation of Advanced Glycosylation End Products (AGEs) in patients with type 2 diabetes mellitus?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers, Outcome assessors
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 2-3
Intervention(s) planned
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 will be randomized into 2 arms using stratified block randomization.
Arm 1 (intervention arm) will receive a capsule containing Lysine (Amino acid) 500mg, Zinc 5mg and Vitamin C 50mg as active ingredients, to be taken two capsules at a time, three times daily for six months
Arm 2 (control arm) will receive an identical matching placebo at the same frequency for the same duration of six months. The placebo will be manufactured to have a similar appearance, shape, weight, and color as the intervention capsule. Placebo capsule will contain magnesium stearate, microcrystalline cellulose and silicone.
The investigators, health care providers, patients and data collectors would be blinded to the treatment allocations.
Participants in both groups will receive uniform advice about diet and physical activity.
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
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.
Primary outcome(s)
|
1.
Change in HbA1c from baseline in treatment and placebo arms |
[ At baseline End of 3 months End of study (at 6 months) ] |
|
2.
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) ] |
|
3.
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) ] |
|
4.
Change in Oxidative Stress from baseline in treatment and placebo arms |
[ At baseline End of 3 months End of study (at 6 months) ] |
Secondary outcome(s)
|
1.
Percentage of patients with HbA1c <7.0% in treatment and placebo arms |
[ At baseline End of study (at 6 months) ] |
|
2.
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) ] |
|
3.
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) ] |
|
4.
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) ] |
|
5.
Change in Blood Pressure (systolic and diastolic) in treatment and placebo arms |
[ At baseline End of study (at 6 months) ] |
|
6.
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) ] |
Target number/sample size
40 (20 in one arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-10-15
Anticipated end date
2021-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Lysulin Inc, USA
Regulatory approvals
Applied
Status
Approved
Date of Approval
2020-08-20
Approval number
EC-20-035
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Ranil Jayawardena
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka
0112695300
0718323332
ranil7@gmail.com
http://med.cmb.ac.lk/index.php/department-of-physiology-staff?id=234
Contact Person for Public Queries
Priyanga Ranasinghe
Senior Lecturer
Department of Pharmacology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka
0112695300
0772770202
priyanga.ranasinghe@gmail.com
http://med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=269
Primary study sponsor/organization
Dr. Jhon Burd
Chief Executive Officer
4940, Bradshaw Court, San Diego, California, USA
619-992-2871
info@lysulin.com
https://lysulin.com/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
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
