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GLycaemic Outcomes With Whey Protein in ageING

Sponsor: University of Birmingham

NCT ID: NCT07285811

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Glycaemic control with whey protein (supplement), Glycaemic control with different doses of whey protein (supplement)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
Glycaemic control with whey protein — supplement: Comparing pre-meal supplementation of whey protein to protein-free placebo. · Glycaemic control with different doses of whey protein — supplement: Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
70 Years to 90 Years
Who
All
Number of participants
32
Started
2026-01-02
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for type 2 diabetes
  • • NA - 32 participants
  • • 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

Who can take part?

  • • Ages 70 Years to 90 Years
  • • Diagnosed with type 2 diabetes

Where?

  • • Birmingham - School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
  • • Birmingham - Heartlands Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Within the study, the researchers will look at the effect of supplemental whey protein at moderate and low doses in comparison to each other and a protein-free placebo on glycaemic control in older adults aged between 70-90 years of age, living with type 2 diabetes. Glycaemic control (glucose excursions) will be monitored under free-living conditions over a 7-day period using continuous glucose monitors (CGMs). Participants will be randomised to consume one of the two whey protein doses as well as the protein-free placebo on a separate 7-day period. The order of consuming whey protein or the protein-free placebo will be randomised and counterbalanced. This study is under the evidence that in younger people living with type 2 diabetes, a moderate dose of whey protein improves glucose time in range and lessens extreme postprandial glucose excursions. Participants will be free to consume their typical diet over this period, where the researchers will provide a diet diary for participants to enter in all foods and drinks they consume over this time period, as well as document the ingestion of the supplement before each main meal. During an acute feeding period on the first ingestion of each supplement (start of each 7-day phase), the researchers will evaluate rates of gastric emptying, glucose and insulin concentrations and hormonal appetite markers through blood draws, as well as perceived appetite responses through visual analogue scales. This will be in a research kitchen where participants will consume the supplement and a controlled mixed meal afterwards to monitor excursions in appetite response and glycemia. The researchers will also investigate the impact of pre-meal protein feeding on renal markers following each 7-day phase via urine collection.

Type 2 Diabetes

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 70 Years - 90 Years
  • Who can join: All genders

Who cannot take part

  • ✗\<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
See the full 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 Is This Study? (2 UK sites)

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham

Birmingham B15 2TT, United Kingdom

ENROLLING_BY_INVITATION
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Heartlands Hospital

Birmingham, United Kingdom

Recruiting
Site contact (verified)
Srikanth Bellary, MD4240234

How to Get in Touch

Leigh Breen, PhD

Sponsor contact

CONTACT

(0)1214144109 l.breen@bham.ac.uk

Marie Korzepa, PhD

Sponsor contact

CONTACT

m.korzepa@bham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-01