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GLycaemic Outcomes With Whey Protein in ageING

RecruitingNAAges 70 Years - 90 YearsAllUniversity of Birmingham
NCT07285811 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (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
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What it tests

  • Glycaemic control with whey protein
  • Glycaemic control with different doses of whey protein
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Where

2 sites
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, United Kingdom
Heartlands Hospital
Birmingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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