GLycaemic Outcomes With Whey Protein in ageING (NCT07285811) | Clinical Trial Compass
RecruitingNot Applicable
GLycaemic Outcomes With Whey Protein in ageING
United Kingdom32 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range
75 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Male or female
* 75-90 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:
* \<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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of changes in free-living glycaemic control
Timeframe: 7 days, two occasions
2
Changes in postprandial glucose concentrations in blood