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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 75
Maximum Age: 90
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
Heartlands Hospital
RECRUITING
Birmingham
School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham
ENROLLING_BY_INVITATION
Birmingham
Contact Information
Primary
Leigh Breen, PhD
l.breen@bham.ac.uk
(0)1214144109
Backup
Marie Korzepa, PhD
m.korzepa@bham.ac.uk
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 32
Treatments
Active_comparator: pre-meal low dose whey protein
Low whey protein dose administration before meals
Active_comparator: pre-meal moderate dose whey protein
Moderate whey protein dose administration before meals
Placebo_comparator: pre-meal protein-free placebo
protein-free placebo administration before meals
Related Therapeutic Areas
Sponsors
Leads: University of Birmingham
Collaborators: Newcastle University

This content was sourced from clinicaltrials.gov