GLycaemic Outcomes With Whey Protein in ageING
Recruiting · NCT07285811 · Interventional (participants receive a specific treatment) · Lead sponsor:
University of Birmingham
View the official record on ClinicalTrials.gov →
Interventions studied
Glycaemic control with different doses of whey proteinGlycaemic control with whey protein
What this trial is about
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 70-90 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.
Who can take part
Age range
70 Years to 90 Years
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
* Male or female
* 70-90 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 Criteria:
* \<70 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
Where it is running
2 locations listed.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →