Type 2 DiabetesGLOWINGNCT07285811
GLycaemic Outcomes With Whey Protein in ageING
A study of Type 2 Diabetes and Appetite Regulation, run by University of Birmingham at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Appetite Regulation, Whey Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 2 Jan 2026to 31 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- <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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Korzepa, PhD contact
United Kingdom2 sites, 2 recruiting
- Enrolling by invitation
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
Birmingham, West Midlands, B15 2TT
- Recruiting
Heartlands Hospital
Birmingham
Srikanth Bellary, MD, 4240234 ext. 0121
About this study
Official title: Whey Protein Dose-response Effect on Daily Glycaemic Excursions in Very Old Individuals With Type 2 Diabetes
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.
Read the detailed description
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.
- Being tested
- Glycaemic control with whey protein, Glycaemic control with different doses of whey protein
- Keywords
- Glucose Control, Type 2 Diabetes, Ageing, Whey Protein
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycaemic control with whey proteinDietary supplement
Comparing pre-meal supplementation of whey protein to protein-free placebo.
Glycaemic control with different doses of whey proteinDietary supplement
Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.
| Study group | Role | What they receive |
|---|---|---|
| pre-meal low dose whey protein | Active comparator | Low whey protein dose administration before meals Receives: Dietary Supplement: Glycaemic control with whey protein; Dietary Supplement: Glycaemic control with different doses of whey protein |
| pre-meal moderate dose whey protein | Active comparator | Moderate whey protein dose administration before meals Receives: Dietary Supplement: Glycaemic control with whey protein; Dietary Supplement: Glycaemic control with different doses of whey protein |
| pre-meal protein-free placebo | Placebo comparator | protein-free placebo administration before meals Receives: Dietary Supplement: Glycaemic control with whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of changes in free-living glycaemic control
Time spent in normal glucose range, under free-living conditions with pre-meal supplementation (measured by continuous glucose monitors)
Measured: 7 days, two occasions
Changes in postprandial glucose concentrations in blood
Amplitude of post-meal blood glucose following supplement(s) and controlled meal
Measured: 4 hours, two occasions
Concentrations of insulin postprandially in blood
Insulin appearance in blood following supplement(s) and controlled meal
Measured: 4 hours, two occasions
Secondary outcomes (7)
Concentrations of amino acids postprandially in blood
Total amino acid appearance in blood following supplement(s) and controlled meal
Measured: 4 hours, two occasions
Concentrations of postprandial appetite hormones
Postprandial appetite hormone concentrations in blood following supplement(s) and controlled meal
Measured: 4 hours, two occasions
Rate of gastric emptying
Rate of gastric emptying using acetaminophen appearance in the blood following its consumption with supplement(s) and controlled meal.
Measured: 4 hours, two occasions
Changes in renal function markers after each 7-day phase
Measurement of markers of renal function from urine following each 7-day phase
Measured: 2 urine samples, 2 occasions
Assessment of nitrogen balance from urine after each 7-day phase
Nitrogen balance from 24-hour urine collection after each 7-day phase
Measured: 24 hours, two occasions
Measurement of blood lipid concentration
Total cholesterol measurement in blood at rest
Measured: 1 blood draw (obtained from the first blood draw as part of 4 hour visit)
Optional qualitative assessment of perceptions to supplementation
Optional interview for participants to share perceptions of pre-meal supplementation
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start2 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled partial crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Sponsor
- Investigators
- Leigh Breen, PhD, Principal investigator, University of Birmingham and University of Leciester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285811
- Sponsor's protocol ID
- RG_24-052
- Acronym
- GLOWING
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No