NCT03851666

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Onorach Clinical Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pre-diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	12 weeks daily administration Cereal 1	The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product. Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation. The daily dose administrated is 15 grams.
DIETARY_SUPPLEMENT	12 weeks daily administration Cereal 2	The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product. Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation. The daily dose administrated is 15 grams.
OTHER	12 weeks daily administration Placebo	The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of placebo. Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.

Timeline

• Start date: 2018-08-09
• Primary completion: 2019-07-09
• Completion: 2019-10-31
• First posted: 2019-02-22
• Last updated: 2019-11-04

Locations

2 sites across 1 country: Latvia