MedTrace Logo

Effect of Protein Hydrolysates on HbA1c Levels in Pre-diabetics

NCT03083600 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-01-11

No results posted yet for this study

Summary

To evaluate the effectiveness of three different daily doses of plant protein hydrolysates versus placebo, when consumed over a 12-week period, at reducing and maintaining glycated haemoglobin (HbA1c) levels in a pre-diabetic population (otherwise healthy subjects with impaired glucose metabolism).

To evaluate the effectiveness of three different daily doses of pea or rice protein hydrolysates versus placebo, when consumed over a 12-week period on: post-prandial glucose/insulin levels (oral glucose tolerance test, fructosamine levels, fasting plasma glucose levels, vital signs, physical examinations, weight and blood pressure.

Conditions

Interventions

DIETARY_SUPPLEMENT

Plant-based Protein Hydrolysate 1

Plant-based Protein Hydrolysate 2 for 12-weeks

DIETARY_SUPPLEMENT

Plant-based Protein Hydrolysate 2

Plant-based Protein Hydrolysate 2 for 12-weeks

DIETARY_SUPPLEMENT

Placebo

Cellulose Placebo for 12-weeks

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    lead INDUSTRY

Principal Investigators

  • Fergus Shanahan, MD · Cork University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083600 on ClinicalTrials.gov