Whey Protein Effect on Glycaemic and Appetite Responses in T2D

September 12, 2016 updated by: Northumbria University

The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males

The current study will investigate the effect if whey protein on postprandial glycaemia and appetite in type II diabetics, assessing incretin (GLP-1, GIP), insulin, and appetite control (leptin, PYY3-36) hormone responses.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Whey protein accounts of ~20% of whole milk protein. Ingestion of whey protein at meal times generates insulinotrophic/β-cell stimulation via amino acid absorption and the bioactive peptides generated during gastrointestinal digestion, resulting in attenuation of postprandial blood glucose. The bioactive peptides stimulate the release of incretin hormone, GLP-1, and inhibit DPP-IV activity potentially decreasing the rate of GLP-1 degradation.

The current study will employ a randomised, double-blind, counter-balanced, cross-over design, whereby participants will each complete three trials; a) whey protein, b) hydrolysed protein, and c) placebo intervention. Hydrolysed protein provides amino acid content, without bioactive peptides associated with incretin release, therefore, demonstrating insulinotrophic properties, only.

Many studies within the literature are limited for practical reasons, such as investigating high dosages (30-50 g) of whey protein, or high glycaemic index meal types which would be unlikely to form part of habitual dietary activity of type II diabetics. Therefore, the current study will objectively measure postprandial glycaemic and appetite responses following the ingestion of whey/hydrolysed protein, whilst ensuring ecological validity, dosages (18 g) and test meals applicable to everyday life, and true clinical utility for managing type-II diabetes by integrating interventions into the habitual lives of type-II diabetic individuals.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Tyne & Wear
      • Newcastle-upon-Tyne, Tyne & Wear, United Kingdom, NE1 8ST
        • Northumbria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Type II diabetic males aged 18-65 years old.
  • Treated with metformin, or diet and lifestyle modification, only.
  • BMI < 40 kg/m2.
  • Stable physical activity pattern during the three months immediately preceding study.

Exclusion Criteria:

  • Not treated with insulin.
  • No metabolic disease other than diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whey Protein
Whey protein (18g) experimental supplement
Dietary supplement: Whey Protein
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
Experimental: Hydrolysed Protein
Hydrolysed whey protein (19.1g) experimental supplement
Dietary supplement: Hydrolysed Protein
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
Placebo Comparator: Placebo
Water placebo supplement
Dietary supplement: Placebo
Placebo intervention administered immediately prior to breakfast and lunch meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial capillary glucose
Time Frame: 6 hours per week, for 3 weeks.
Capillary glucose concentrations are monitored for 6 hours/wk following breakfast (09:00-12:00) and lunch (12:15-15:15).
6 hours per week, for 3 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucagon-like Peptide-1 (GLP-1)
Time Frame: 3 weeks
GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
3 weeks
Plasma Gastric Inhibitory Polypeptide (GIP)
Time Frame: 3 weeks
GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
3 weeks
Plasma Leptin
Time Frame: 3 weeks
Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
3 weeks
Plasma Peptide YY (PYY3-36)
Time Frame: 3 weeks
PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
3 weeks
Plasma Insulin
Time Frame: 3 weeks
Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
3 weeks
Serum Triglycerides
Time Frame: 3 weeks
Triglycerides will be measured from Serum Separating Tubes (SST).
3 weeks
Serum Glycerol
Time Frame: 3 weeks
Glycerol will be measured from Serum Separating Tubes (SST).
3 weeks
Self-Report Questionnaire for Appetite
Time Frame: 3 weeks
Visual Analogue Scales (VAS) will be used to assess self reported feelings of appetite sensations (i.e. hunger, satiety, prospective food intake).
3 weeks
24 h Interstitial Glucose
Time Frame: 3 days per week, for 3 weeks
Interstitial glucose is measured from 36 h prior to the trial, until 24 h following the trial, each week for three weeks.
3 days per week, for 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Investigators

  • Principal Investigator: Mark Walker, Newcastle University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorthumbriaT2D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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