GLycaemic Outcomes With Whey Protein in ageING

NCT07285811 | Recruiting DMC

• 1 other identifier: RG_24-052
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• 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)

  7 days, two occasions

• Changes in postprandial glucose concentrations in blood

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

  4 hours, two occasions

• Concentrations of insulin postprandially in blood

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

  4 hours, two occasions

Secondary Outcomes (7)

• Concentrations of amino acids postprandially in blood

  4 hours, two occasions

• Concentrations of postprandial appetite hormones

  4 hours, two occasions

• Rate of gastric emptying

  4 hours, two occasions

• Changes in renal function markers after each 7-day phase

  2 urine samples, 2 occasions

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

  24 hours, two occasions

Study Arms (3)

pre-meal low dose whey protein

ACTIVE COMPARATOR

Low whey protein dose administration before meals

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

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

Dietary Supplement: Glycaemic control with whey protein

Interventions

Glycaemic control with whey protein DIETARY_SUPPLEMENT

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

pre-meal low dose whey protein; pre-meal moderate dose whey protein; pre-meal 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.

pre-meal low dose whey protein; pre-meal moderate dose whey protein

Eligibility Criteria

• Age: 75 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may not qualify if:

• \<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

Sponsors & Collaborators

• University of Birmingham: lead
• Newcastle University: collaborator

Study Sites (2)

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

Birmingham, West Midlands, B15 2TT, United Kingdom

ENROLLING BY INVITATION

Heartlands Hospital

Birmingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Leigh Breen, PhD

  University of Birmingham and University of Leciester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh Breen, PhD

CONTACT

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

Marie Korzepa, PhD

CONTACT

m.korzepa@bham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo-controlled partial crossover

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2024-12

Locations

GB (2)