Home » Trials » SLCTR/2018/022

Effects of the LysulinTM supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial


SLCTR Registration Number


Date of Registration

13 Jul 2018

The date of last modification

Jan 28, 2019

Application Summary

Scientific Title of Trial

Effects of the LysulinTM supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial

Public Title of Trial

Effect of LysulinTM supplementation on blood glucose control in pre-diabetes

Disease or Health Condition(s) Studied


Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

What is the research question being addressed?

Does LysulinTM supplementation improve glycaemic control in patients with pre-diabetes?

Type of study


Study design


Randomized controlled trial


Double blinded







Study Phase

Phase 4

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 tablet containing LysulinTM supplementation (1130mg), to be taken orally three times daily for a period of 6 months. Each Lysulin tablet contains, Lysine (Amino acid) 1000mg, Zinc 10mg, Vitamin C 100mg and Magnesium stearate 20mg.

Arm 2 (control arm) will receive an identical matching placebo at the same frequency for the same duration. The placebo will be manufactured to have a similar appearance, shape, weight, and color as the LysulinTM tablet. The placebo tablet will contain rice flour (500mg), magnesium stearate (175mg), microcrystalline cellulose (425mg) and silicone (30mg).

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 18-60 years

b) Both male and female

c) Screening test confirming presence of pre-diabetes as defined by Fasting Plasma Glucose (FPG) between 100-125mg/dl (Impaired Fasting Glucose [IFG]) or 2-hr Post Oral Glucose Tolerance Test (OGTT) Plasma Glucose between 140-199mg/dl (Impaired Glucose Tolerance [IGT]) or both IFG and IGT or a HbA1c value between 6.0-6.4%.

Exclusion criteria

  1. On any other vitamin or mineral supplementation

  2. The current use of a weight loss medicine or dietary modification

  3. History of diabetes mellitus

  4. Presently having acute diseases requiring treatment (too numerous and diverse to be named individually)

  5. Impaired hepatic or renal functions

6.Patients with any malignancy or any other unrelated chronic illness, such as chronic kidney disease, ischaemic heart disease. Etc (again too numerous and diverse to be named individually)

7.Patients with cardiac, liver or respiratory failure

8.Any condition in the opinion of the primary investigator that would contraindicate the patient's participation

9.Allergy to any of the constituents of the investigational tablets.



12.Unwillingness to use an effective form of birth control for women of child bearing years.

Primary outcome(s)

  1. Change in HbA1c from baseline in treatment and placebo arms


    At baseline

  2. Change in Fasting Plasma Glucose (FPG) from baseline in treatment and placebo arms


    End of three months from starting therapy

  3. Change in 2-hour OGTT plasma glucose from baseline in treatment and placebo arms


    End of study (6 months).


Secondary outcome(s)

  1. Percentage of patients developing diabetes during follow-up, as indicated by either FPG >125mg/dL and/or 2-hour OGTT plasma glucose of >199mg/dL and/or HbA1C>6.5%, confirmed during follow-up visits


    At baseline

  2. Change in BMI and other anthropometric parameters (weight, waist circumference, hip circumference, waist:hip ratio) from baseline


    End of three months from starting therapy

  3. Change in blood pressure (systolic and diastolic) from baseline 4) Change in the Lipid Profile (Total cholesterol, LDL, HDL and TAG) from baseline


    End of study (6 months).


Target number/sample size

110 (55 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

Lysulin Inc, USA

Regulatory approvals

Not applicable

State of Ethics Review Approval



Date of Approval


Approval number


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 & Sponsor Information

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


Contact Person for Public Queries

Dr. Priyanga Ranasinghe
Department of Pharmacology, Faculty of Medicine, University of Colombo, No 25, Kynsey Road, Colombo 08, Sri Lanka


Primary study sponsor/organization

Dr. Jhon Burd
Chief Executive Officer
4940, Bradshaw Court, San Diego, California, USA


Secondary study sponsor (If any)


Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Not Available

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results