Clinical trial Recruiting at 1 site Interventional Ages 70 to 90

Whey protein before meals to improve blood sugar in older adults with type 2 diabetes

Official title: Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes

Run by University of Birmingham · NCT07285811 · Data updated 2026-11-12

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.

More Type 2 Diabetes trials

Quick facts

Study typeInterventional
Ages70 Years to 90 Years
SexAll
Enrollment32 (estimated)
SponsorUniversity of Birmingham
Academic / other
Locations2 sites (Birmingham, West Midlands and 1 other locations)
StatusRecruiting
StartedJanuary 2, 2026
Main results expectedMarch 31, 2027
Study endsMay 31, 2027
Registry record updatedOctober 22, 2026
Trial IDNCT07285811 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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).

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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's running

  • Heartlands Hospital
    Birmingham, United Kingdom
    Recruiting
  • School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
    Birmingham, West Midlands, United Kingdom
    Enrolling by invitation

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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.