Whey Protein Effect on Glycaemic and Appetite Responses in T2D

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Type II Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Whey Protein
* Dietary Supplement: Hydrolysed Protein
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial capillary glucose | 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) | GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. | 3 weeks | 
| Plasma Gastric Inhibitory Polypeptide (GIP) | GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. | 3 weeks | 
| Plasma Leptin | Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. | 3 weeks | 
| Plasma Peptide YY (PYY3-36) | PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. | 3 weeks | 
| Plasma Insulin | Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. | 3 weeks | 
| Serum Triglycerides | Triglycerides will be measured from Serum Separating Tubes (SST). | 3 weeks | 
| Serum Glycerol | Glycerol will be measured from Serum Separating Tubes (SST). | 3 weeks | 
| Self-Report Questionnaire for Appetite | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Whey Protein, Postprandial Glycaemia, Appetite Response