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NCT Number: NCT07285811

GLycaemic Outcomes With Whey Protein in ageING

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 75-90 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.

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Key information

Age range

75 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, West Midlands, United Kingdom

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About this study

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 75-90 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Male or female
  • 75-90 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

  • <75 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

Treatment and study plan

Glycaemic control with whey protein

Dietary Supplement

Comparing pre-meal supplementation of whey protein to protein-free placebo.

Glycaemic control with different doses of whey protein

Dietary Supplement

Comparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.

Primary outcomes

  1. Measurement of changes in free-living glycaemic control

    Time frame: 7 days, two occasions

    Time spent in normal glucose range, under free-living conditions with pre-meal supplementation (measured by continuous glucose monitors)

  2. Changes in postprandial glucose concentrations in blood

    Time frame: 4 hours, two occasions

    Amplitude of post-meal blood glucose following supplement(s) and controlled meal

  3. Concentrations of insulin postprandially in blood

    Time frame: 4 hours, two occasions

    Insulin appearance in blood following supplement(s) and controlled meal

Secondary outcomes

  1. Concentrations of amino acids postprandially in blood

    Time frame: 4 hours, two occasions

    Total amino acid appearance in blood following supplement(s) and controlled meal

  2. Concentrations of postprandial appetite hormones

    Time frame: 4 hours, two occasions

    Postprandial appetite hormone concentrations in blood following supplement(s) and controlled meal

  3. Rate of gastric emptying

    Time frame: 4 hours, two occasions

    Rate of gastric emptying using acetaminophen appearance in the blood following its consumption with supplement(s) and controlled meal.

  4. Changes in renal function markers after each 7-day phase

    Time frame: 2 urine samples, 2 occasions

    Measurement of markers of renal function from urine following each 7-day phase

  5. Assessment of nitrogen balance from urine after each 7-day phase

    Time frame: 24 hours, two occasions

    Nitrogen balance from 24-hour urine collection after each 7-day phase

  6. Measurement of blood lipid concentration

    Time frame: 1 blood draw (obtained from the first blood draw as part of 4 hour visit)

    Total cholesterol measurement in blood at rest

  7. Optional qualitative assessment of perceptions to supplementation

    Time frame: 60 minutes

    Optional interview for participants to share perceptions of pre-meal supplementation

Study contacts

Contact information is provided by the study sponsor or research team.

Leigh Breen, PhD

CONTACT

[email protected]

(0)1214144109 ext. +44

Marie Korzepa, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Newcastle University

Registry information

Official study title

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

Acronym: GLOWING

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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