An interventional study of Glycaemic control with whey protein and Glycaemic control with different doses of whey protein in Type 2 Diabetes, Appetite Regulation and Whey Protein, sponsored by University of Birmingham. Recruiting at 2 sites in United Kingdom. Open to participants aged 70 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Birmingham · Not applicable, Interventional, and Basic science
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 32 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low whey protein dose administration before meals
Dietary Supplement: Glycaemic control with whey protein · Dietary Supplement: Glycaemic control with different doses of whey protein
Moderate whey protein dose administration before meals
Dietary Supplement: Glycaemic control with whey protein · Dietary Supplement: Glycaemic control with different doses of whey protein
protein-free placebo administration before meals
Dietary Supplement: Glycaemic control with whey protein
Comparing pre-meal supplementation of whey protein to protein-free placebo.
Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.
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)
Time frame: 7 days, two occasions
Changes in postprandial glucose concentrations in blood
Amplitude of post-meal blood glucose following supplement(s) and controlled meal
Time frame: 4 hours, two occasions
Concentrations of insulin postprandially in blood
Insulin appearance in blood following supplement(s) and controlled meal
Time frame: 4 hours, two occasions
Concentrations of amino acids postprandially in blood
Total amino acid appearance in blood following supplement(s) and controlled meal
Time frame: 4 hours, two occasions
Concentrations of postprandial appetite hormones
Postprandial appetite hormone concentrations in blood following supplement(s) and controlled meal
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 24 hours, two occasions
Measurement of blood lipid concentration
Total cholesterol measurement in blood at rest
Time frame: 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
Time frame: 60 minutes
Started Jan 2026 (actual). Primary completion is estimated for Mar 2027, 14 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 14 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Sep 2026 → Mar 2027 and completion Dec 2026 → May 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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