Whey Protein Effect on Glycaemic and Appetite Responses in T2D

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02903199
• Other study ID #: NorthumbriaT2D
• Status: Active, not recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: September 12, 2016
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 11
• Est. completion date: October 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders
• Metabolic Diseases
• Type II Diabetes Mellitus

Intervention

Dietary Supplement:
• Whey Protein
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
• Hydrolysed Protein
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
• Placebo
Placebo intervention administered immediately prior to breakfast and lunch meals.

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle-upon-Tyne	Tyne & Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Plasma Glucagon-like Peptide-1 (GLP-1)	GLP-1 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.	3 weeks	No
Secondary	Plasma Gastric Inhibitory Polypeptide (GIP)	GIP will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.	3 weeks	No
Secondary	Plasma Leptin	Leptin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.	3 weeks	No
Secondary	Plasma Peptide YY (PYY3-36)	PYY3-36 will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.	3 weeks	No
Secondary	Plasma Insulin	Insulin will be measured from blood collection tubes containing EDTA, aprotinin, and DPPIV inhibitor.	3 weeks	No
Secondary	Serum Triglycerides	Triglycerides will be measured from Serum Separating Tubes (SST).	3 weeks	No
Secondary	Serum Glycerol	Glycerol will be measured from Serum Separating Tubes (SST).	3 weeks	No
Secondary	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	No
Secondary	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	No