Clinical trial NCT02903199: Whey Protein Effect on Glycaemic and Appetite Responses in T2D
Official title: The Effect of Pre-meal Whey Protein on Glycaemic and Appetite Responses in Type II Diabetic Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type II Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Keywords: Whey Protein
Postprandial Glycaemia
Appetite Response
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postprandial capillary glucose
timeFrame: 6 hours per week, for 3 weeks.
Secondary outcomes:
measure: Plasma Glucagon-like Peptide-1 (GLP-1)
timeFrame: 3 weeks
measure: Plasma Gastric Inhibitory Polypeptide (GIP)
timeFrame: 3 weeks
measure: Plasma Leptin
timeFrame: 3 weeks
measure: Plasma Peptide YY (PYY3-36)
timeFrame: 3 weeks
measure: Plasma Insulin
timeFrame: 3 weeks
measure: Serum Triglycerides
timeFrame: 3 weeks
measure: Serum Glycerol
timeFrame: 3 weeks
measure: Self-Report Questionnaire for Appetite
timeFrame: 3 weeks
measure: 24 h Interstitial Glucose
timeFrame: 3 days per week, for 3 weeks
Other outcomes:
Locations:
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne & Wear
Study officials:
affiliation: Newcastle University
name: Mark Walker
role: PRINCIPAL_INVESTIGATOR
References:
citation: King DG, Walker M, Campbell MD, Breen L, Stevenson EJ, West DJ. A small dose of whey protein co-ingested with mixed-macronutrient breakfast and lunch meals improves postprandial glycemia and suppresses appetite in men with type 2 diabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Apr 1;107(4):550-557. doi: 10.1093/ajcn/nqy019.