Whey protein on free-living glycaemic control in T2D. (WP/T2D)
Research type
Research Study
Full title
The influence of pre-meal whey protein supplementation on appetite and energy intake and free-living glycaemic control in adults with type 2 diabetes: a randomised-control trial.
IRAS ID
246180
Contact name
Daniel J West
Contact email
Sponsor organisation
Newcastle upon Tyne NHS Foundation Trust
Clinicaltrials.gov Identifier
ISRCTN17563146
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Type 2 diabetes mellitus (T2D) is a metabolic disease characterised by an inability to secrete insulin in response to carbohydrates. However, where carbohydrate-induced insulin secretion is lost, protein-derived insulin secretion remains normalised in T2D. As such, acute interventions have shown that consuming large doses of whey protein (WP) before meals reduces high-blood sugars with T2D. However, it is not known if the reported benefits are retained in smaller amounts of WP, nor if WP consumption influences blood glucose control in patient’s home settings, limiting the practicality of WP as a nutritional treatment for T2D.
Twenty-two adult patients with T2D will be recruited into a nutritional intervention examining the influence of a novel small WP shot on free-living blood glucose control and energy intake. Patients will be randomly assigned to consume one of two WP beverages before each of their main meals at home for 7d (“free-living” period). Fourteen days later, patients will consume a different WP drink (i.e. crossover) for a further 7d. Prior to and immediately following each free-living period, patients will consume their assigned beverage prior to a mixed-meal test: a breakfast and “all you can eat” lunch meal. A short interview will be conducted to assess patient experiences following each 7d period, highlighting potential barriers surrounding the use of WP for diabetes care.
This study is funded by Arla Foods Ingredients Group P/S (Denmark) from a grant awarded to Newcastle University. Patients will be required to attend to the Clinical Research Facility (CRF), Royal Victoria Infirmary, Newcastle upon Tyne a total of 6 times over a 4 week period. On patients first and fourth visit, a continuous glucose monitoring system (CGM) will be fitted to capture free-living glucose control. Mixed-meal tests will occur on visits 2, 3 (i.e. pre and post the first free-living period), 5 and 6 (i.e. pre and post the second free-living period). Blood samples and measures of appetite will be collected during the mixed-meal tests, where energy intake will be assessed by an “all you can eat” lunch meal. Physical activity and dietary intake will be monitored throughout the intervention period.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0372
Date of REC Opinion
16 Jan 2019
REC opinion
Further Information Favourable Opinion