GLycaemic Outcomes With Whey Protein in ageING
Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes
University of Birmingham
32 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this placebo-controlled, partial crossover design study is to identify the impact of consuming whey protein before meals on free-living glucose control in older adults living with type 2 diabetes. The primary specific objective is to determine the effect of a thrice daily whey protein pre-meal supplementation at two doses, on glucose excursions over a 7-day free-living period in adults aged 75-90 years of age, living with type 2 diabetes, compared with a non-protein placebo. Participants will consume the whey protein and placebo for 7 days each, before each meal. All participants will consume the placebo and one of two doses of whey protein, in a randomised order.
Eligibility
Inclusion Criteria9
- Male or female
- years old
- Type 2 Diabetes (confirmed with glycated haemoglobin (HbA1c) \>6.5% in clinic or in SportExR)
- Stable body mass (body mass index (BMI) ≤40kg/m2)
- Generally healthy, assessed via a General Health Questionnaire (GHQ)
- Some residual beta-cell activity (confirmed with urine test on induction)
- Normal or moderately increased albuminuria (needs to be below 300mg/g)
- Normal, mildly or moderately decreased glomerular filtration rate (GFR) (needs to be above 45ml/min/1.732).
- Able and willing to attend SportExR a total of 5 times: 1 induction and 2 testing visits and 2 return check-up visits.
Exclusion Criteria13
- \<75 years old and over 90 years of age
- Currently on fast-acting insulin therapy (i.e., Humalog)
- Confirmed uncontrolled diabetes (HbA1C \>10% or 85mmol/mol).
- Currently on GLP-1 therapy
- Habitual smoker or vaper
- Veganism
- Lactose or dairy intolerance
- Coeliac or gluten intolerance
- History of gastrointestinal disease
- Experienced a hyperglycaemic or hypoglycaemic event requiring treatment in the past 12 months
- Recent Ischemic stroke (\<3 months).
- Use of anticoagulants (e.g. warfarin, rivaroxaban)
- Considered unwilling or unable to comply with the study protocol requirements by the research team
Interventions
Comparing pre-meal supplementation of whey protein to protein-free placebo.
Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07285811