This trial is active, not recruiting.

Conditions type ii diabetes mellitus, glucose metabolism disorders, metabolic diseases
Treatments whey protein, hydrolysed protein, placebo
Sponsor Northumbria University
Start date July 2015
End date February 2016
Trial size 11 participants
Trial identifier NCT02903199, NorthumbriaT2D


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Whey protein (18g) experimental supplement
whey protein
Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
Hydrolysed whey protein (19.1g) experimental supplement
hydrolysed protein
Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
(Placebo Comparator)
Water placebo supplement
Placebo intervention administered immediately prior to breakfast and lunch meals.

Primary Outcomes

Postprandial capillary glucose
time frame: 6 hours per week, for 3 weeks.

Secondary Outcomes

Plasma Glucagon-like Peptide-1 (GLP-1)
time frame: 3 weeks
Plasma Gastric Inhibitory Polypeptide (GIP)
time frame: 3 weeks
Plasma Leptin
time frame: 3 weeks
Plasma Peptide YY (PYY3-36)
time frame: 3 weeks
Plasma Insulin
time frame: 3 weeks
Serum Triglycerides
time frame: 3 weeks
Serum Glycerol
time frame: 3 weeks
Self-Report Questionnaire for Appetite
time frame: 3 weeks
24 h Interstitial Glucose
time frame: 3 days per week, for 3 weeks

Eligibility Criteria

Male participants from 18 years up to 65 years old.

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.

Additional Information

Official title The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males
Principal investigator Mark Walker
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Northumbria University.