Effect of a Plant-based Hydrolysates Daily Consumption on the HbA1c of Pre-diabetic Subjects

Pre-diabetes Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Exploratory Study to Assess the Effect of a Once Daily Administration of a Plant-based Hydrolysates in the Reduction of Hb1A) Levels in Pre-diabetic Volunteers.

Status Completed

Clinical Trial Summary

This study evaluates the effect in HbA1c levels of a once daily administration of plant-based hydrolysates in pre-diabetic, but otherwise healthy volunteers. Among the 63 subjects enrolled, 21 will receive a plant-based hydrolysates from one cereal, 21 will receive a plant-based hydrolysates from another cereal and 21 will receive a placebo.

Clinical Trial Description

Pre-clinical data on human skeletal muscle cells and mouse Type 2 diabetes model have shown a blood glucose lowering effect of the plant-based hydrolysates.

The first objective of the study is to evaluate the effect of a once daily administration of 2 different cereal protein hydrolysates versus placebo, when consumed over a 12-week period, at reducing the preferred outcome measure identified by the European Food Safety Authority i.e. glycated haemoglobin (HbA1c) levels in pre-diabetic volunteers who are otherwise healthy subjects.

The second objective of the study is to evaluate the effect of a fixed daily administration of 2 different cereal protein hydrolysates versus placebo, when consumed over a 12-week period on further supportive measures like Post-prandial glucose/insulin levels, fructosamine level, fasting plasma glucose level, vital signs and blood pressure, weight and BMI. ;

Related Conditions & MeSH terms

• Pre-diabetes
• Prediabetic State

• NCT number: NCT03851666
• Study type: Interventional
• Source: Onorach Clinical Ltd
• Status: Completed
• Phase: N/A
• Start date: August 9, 2018
• Completion date: October 31, 2019