Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Diabetes mellitus is rapidly becoming one of the leading causes of morbidity and mortality worldwide. Preventive measures have become important, especially in the South Asian region and other parts of the world where diabetes is becoming increasingly prevalent. We postulate that a product containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects on glycemic control and disease progression in patients with pre-diabetes and we aim to evaluate this hypothesis using a phase II/III randomized double-blind controlled clinical trial design.

Methods/design

The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 6 months. The study has been approved by the Ethics Review Committee of Facu

SUBMITTER: Ranasinghe P 

PROVIDER: S-EPMC6421713 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature