Whey protein before meals to improve blood sugar in older adults with type 2 diabetes
Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes
This study will try giving people aged 75–90 with type 2 diabetes a whey protein supplement before meals to see if it improves daily blood sugar control compared with a protein-free placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 75 Years to 90 Years |
| Sex | All |
| Sponsor | University of Birmingham Academic / other |
| Locations | 2 sites (Birmingham, West Midlands and 1 other locations) |
| Trial ID | NCT07285811 on ClinicalTrials.gov |
What this trial studies
This is a randomised, placebo-controlled partial crossover trial in which participants aged 75–90 with type 2 diabetes will consume a protein-free placebo and one of two doses of whey protein for separate 7-day free-living periods. Continuous glucose monitors (CGMs) will record glucose excursions and time-in-range during each 7-day phase while participants follow their usual diet and log intake. The order of the two assigned whey doses and the placebo is randomised and counterbalanced so each participant acts as their own control for two conditions. On the first day of each phase researchers will also perform acute feeding tests with blood draws to measure gastric emptying, glucose, insulin, appetite hormones and perceived appetite responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 75–90 with type 2 diabetes, BMI ≤40 kg/m2, some residual beta-cell activity, stable weight, acceptable kidney function (GFR >45 ml/min/1.73m2) and willingness to attend five visits in Birmingham.
Not a fit: People on rapid-acting insulin or GLP-1 therapy, those with uncontrolled diabetes (HbA1c >10%), dairy-free or vegan diets, lactose/dairy intolerance, severe gastrointestinal disease, or advanced kidney disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, taking whey protein before meals could reduce post-meal glucose spikes and increase time-in-range, offering a simple dietary option to help older adults manage type 2 diabetes.
How similar studies have performed: Previous studies in younger adults with type 2 diabetes have shown that a moderate pre-meal dose of whey protein can improve time-in-range and reduce postprandial glucose excursions, but this approach has not been widely tested in the very old (75–90 years).
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Birmingham, West Midlands and 1 other locations
- School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham — Birmingham, West Midlands, United Kingdom (Enrolling_by_invitation)
- Heartlands Hospital — Birmingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Leigh Breen, PhD — University of Birmingham and University of Leciester
- Study coordinator: Leigh Breen, PhD
- Email: l.breen@bham.ac.uk
- Phone: (0)1214144109
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.