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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (2 UK sites)
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham B15 2TT, United Kingdom
Heartlands Hospital
Birmingham, United Kingdom
How to Get in Touch
Leigh Breen, PhD
Sponsor contactCONTACT
Marie Korzepa, PhD
Sponsor contactCONTACT
