Actively Recruiting

Phase Not Applicable
Age: 75Years - 90Years
All Genders
Healthy Volunteers
NCT07285811

GLycaemic Outcomes With Whey Protein in ageING

Led by University of Birmingham · Updated on 2025-12-16

32

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of Birmingham

Lead Sponsor

N

Newcastle University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

GLycaemic Outcomes With Whey Protein in ageING

Who Can Participate

Age: 75Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female
  • 75 to 90 years old
  • Diagnosed with type 2 diabetes confirmed by HbA1c >6.5%
  • Stable body mass with BMI ≤40 kg/m2
  • Generally healthy based on a health questionnaire
  • Some remaining beta-cell activity confirmed by urine test
  • Normal or moderately increased albuminuria below 300 mg/g
  • Normal to moderately decreased kidney filtration rate above 45 ml/min/1.732
  • Able and willing to attend five visits including induction, testing, and check-ups
Not Eligible

You will not qualify if you...

  • Younger than 75 or older than 90 years
  • Currently using fast-acting insulin therapy such as Humalog
  • Uncontrolled diabetes with HbA1c >10% or 85 mmol/mol
  • Currently using GLP-1 therapy
  • Habitual smoker or vape user
  • Vegan diet
  • Lactose or dairy intolerance
  • Coeliac disease or gluten intolerance
  • History of gastrointestinal disease
  • Experienced severe low or high blood sugar events requiring treatment in past 12 months
  • Recent ischemic stroke within 3 months
  • Use of blood thinners like warfarin or rivaroxaban
  • Unable or unwilling to follow study procedures as judged by research team

AI-Screening

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Trial Site Locations

Total: 2 locations

1

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

Birmingham, West Midlands, United Kingdom, B15 2TT

Enrolling by Invitation

2

Heartlands Hospital

Birmingham, United Kingdom

Actively Recruiting

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Research Team

L

Leigh Breen, PhD

CONTACT

M

Marie Korzepa, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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