Whey Protein Effect on Glycaemic and Appetite Responses in T2D

Not Applicable

• Conditions: Metabolic Diseases; Type II Diabetes Mellitus; Glucose Metabolism Disorders
• Interventions: Dietary Supplement: Hydrolysed Protein; Dietary Supplement: Placebo; Dietary Supplement: Whey Protein

• Registration Number: NCT02903199
• Lead Sponsor: Northumbria University

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.

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2016-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-09-12
• Last Update Submitted: 2016-09-12
• Study First Posted: 2016-09-16
• Last Update Posted: 2016-09-16
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hydrolysed Protein	Hydrolysed Protein	Hydrolysed whey protein (19.1g) experimental supplement
Placebo	Placebo	Water placebo supplement
Whey Protein	Whey Protein	Whey protein (18g) experimental supplement

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Plasma Gastric Inhibitory Polypeptide (GIP)	3 weeks	GIP 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.
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.
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).
Plasma Insulin	3 weeks	Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.
Serum Triglycerides	3 weeks	Triglycerides will be measured from Serum Separating Tubes (SST).
Serum Glycerol	3 weeks	Glycerol will be measured from Serum Separating Tubes (SST).
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.

Trial Locations

Locations (1)

Northumbria University; 🇬🇧 Newcastle-upon-Tyne, Tyne & Wear, United Kingdom