GLycaemic Outcomes With Whey Protein in ageING
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70-90
SponsorUniversity of Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male or female
70-90 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)
Disqualifiers
<70 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
Trial design
Design model
Crossover
Treatments tested in this trial
Glycaemic control with whey protein
Dietary supplementComparing pre-meal supplementation of whey protein to protein-free placebo.
Glycaemic control with different doses of whey protein
Dietary supplementComparing pre-meal supplementation of moderate whey protein to a low dose of whey protein.
Treatment groups
32 Participants
are divided into 3 treatment groupsGroup A: pre-meal low dose whey proteinActive comparator 2 interventions
Group B: pre-meal moderate dose whey proteinActive comparator 2 interventions
Group C: pre-meal protein-free placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 occasions2
Changes in postprandial glucose concentrations in blood
Amplitude of post-meal blood glucose following supplement(s) and controlled meal
Time frame
4 hours, two occasions3
Concentrations of insulin postprandially in blood
Insulin appearance in blood following supplement(s) and controlled meal
Time frame
4 hours, two occasionsSecondary outcomes
1
Concentrations of amino acids postprandially in blood
Total amino acid appearance in blood following supplement(s) and controlled meal
Time frame
4 hours, two occasions2
Concentrations of postprandial appetite hormones
Postprandial appetite hormone concentrations in blood following supplement(s) and controlled meal
Time frame
4 hours, two occasions3
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 occasions4
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 occasionsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Birmingham
Lead sponsor
Newcastle University
Collaborator
Source ClinicalTrials.gov