Glucose Metabolism Disorders, Metabolic Diseases, Type II Diabetes Mellitus
Conditions
Keywords
Whey Protein, Postprandial Glycaemia, Appetite Response
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.
Interventions
DIETARY_SUPPLEMENTWhey Protein
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
DIETARY_SUPPLEMENTHydrolysed Protein
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
DIETARY_SUPPLEMENTPlacebo
Placebo intervention administered immediately prior to breakfast and lunch meals.
Sponsors
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial capillary glucose | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Gastric Inhibitory Polypeptide (GIP) | 3 weeks | GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. |
| Plasma Leptin | 3 weeks | Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. |
| Plasma Peptide YY (PYY3-36) | 3 weeks | PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. |
| Plasma Insulin | 3 weeks | Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. |
| Plasma Glucagon-like Peptide-1 (GLP-1) | 3 weeks | GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor. |
| Serum Glycerol | 3 weeks | Glycerol will be measured from Serum Separating Tubes (SST). |
| Self-Report Questionnaire for Appetite | 3 weeks | Visual Analogue Scales (VAS) will be used to assess self reported feelings of appetite sensations (i.e. hunger, satiety, prospective food intake). |
| 24 h Interstitial Glucose | 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. |
| Serum Triglycerides | 3 weeks | Triglycerides will be measured from Serum Separating Tubes (SST). |
Countries
United Kingdom
Outcome results
None listed