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GLycaemic Outcomes With Whey Protein in ageING

RECRUITINGN/ASponsored by University of Birmingham
Actively Recruiting
PhaseN/A
SponsorUniversity of Birmingham
Started2025-12
Est. completion2026-08
Eligibility
Age75 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07285811

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

Age: 75 Years – 90 YearsHealthy volunteers accepted
* 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

Conditions2

DiabetesType 2 Diabetes

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