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Trial registered on ANZCTR


Registration number
ACTRN12614001131640
Ethics application status
Approved
Date submitted
9/10/2014
Date registered
23/10/2014
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of protein “preloads” on postprandial glycaemia in type 2 diabetes: a 12-week, single-blind, randomised and placebo-controlled trial.
Scientific title
The effect of a 12-week, single-blind, randomised and placebo-controlled trial of whey protein “preloads” on glycated haemoglobin in patients with type 2 diabetes.
Secondary ID [1] 285470 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus 293247 0
Condition category
Condition code
Diet and Nutrition 293515 293515 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 293516 293516 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protein shake containing 20g whey and 5g guar gum, along with flavouring and artificial sweetener, in 150 mL water, taken 15 min twice daily (before their usual morning and evening meal) for 12 weeks. Adherence will be monitored by package counts every two weeks during the intervention and telephone calls on the alternate weeks.
Intervention code [1] 290407 0
Treatment: Other
Comparator / control treatment
Placebo shake containing flavouring and artificial sweetener in 150 mL water, taken 15 min twice daily (before the morning and evening meal) for 12 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 293334 0
Glycated haemoglobin (HbA1c) - difference in the change in HbA1c after the intervention between active treatment and placebo
Timepoint [1] 293334 0
12 weeks
Secondary outcome [1] 310804 0
Rate of gastric emptying of a standardised meal, consisting of 65g instant mashed potato and 20g glucose, reconstituted with 200 mL water and 1 egg yolk containing 100 microL 13C-octanoic acid, and evaluated using a 13C breath test
Timepoint [1] 310804 0
0 and 12 weeks
Secondary outcome [2] 310805 0
Insulin concentrations, evaluated using plasma assay
Timepoint [2] 310805 0
At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks
Secondary outcome [3] 310806 0
Blood glucose concentrations
Timepoint [3] 310806 0
At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks
Secondary outcome [4] 310807 0
C-peptide concentrations, evaluated using plasma assay
Timepoint [4] 310807 0
At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks
Secondary outcome [5] 310808 0
Incretin hormone concentrations, evaluated using plasma assay
Timepoint [5] 310808 0
At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks
Secondary outcome [6] 310809 0
Appetite scores, evaluated using 100mm visual analogue scales
Timepoint [6] 310809 0
At 0, 15, 30, 60, 90, 120, 180 and 240 min after the standardised meal at 0 and 12 weeks
Secondary outcome [7] 310810 0
Body composition as measured by dual energy X-ray absorptiometry
Timepoint [7] 310810 0
0 and 12 weeks
Secondary outcome [8] 310811 0
Body weight, evaluated using digital weighing scales
Timepoint [8] 310811 0
Week 0, 2, 4, 6, 8, 10, 12
Secondary outcome [9] 310812 0
Energy intake by 3 day diet diary
Timepoint [9] 310812 0
Week 0,2,4,6,8,10,12
Secondary outcome [10] 310813 0
Urinary urea/creatinine ratio
Timepoint [10] 310813 0
Week 0,2,4,6,8,10,12

Eligibility
Key inclusion criteria
- Type 2 diabetes, managed with diet or metformin alone
- HbA1c between 6.0% and 7.9% inclusive
- Body mass index 19-40
- Weight stable
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant gastrointestinal symptoms, or history of gastrointestinal disease
- Proteinuria
- Use of medications likely to affect gastrointestinal function

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation concealment from the investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2014
Actual
3/11/2014
Date of last participant enrolment
Anticipated
Actual
1/12/2016
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
70
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290073 0
Government body
Name [1] 290073 0
National Health and Medical Research Council of Australia
Country [1] 290073 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 288765 0
None
Name [1] 288765 0
Address [1] 288765 0
Country [1] 288765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291778 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 291778 0
Royal Adelaide Hospital North Terrace
Adelaide SA 5000
Ethics committee country [1] 291778 0
Australia
Date submitted for ethics approval [1] 291778 0
Approval date [1] 291778 0
06/01/2014
Ethics approval number [1] 291778 0
313221

Summary
Brief summary
We are undertaking a randomised, placebo-controlled trial of a twice daily protein preload (20 g whey preload mixed with 5 g guar), taken before breakfast and dinner, to test the hypothesis that glycated haemoglobin (HbA1c) will be reduced by at least 0.5% compared to baseline at 12 weeks, in patients with type 2 diabetes who have relatively good glycaemic control (HbA1c less than or equal to 7.9%) on diet or metformin therapy alone.

We will also test the secondary hypothesis that the whey preload (i) will induce slowing of gastric emptying, stimulation of incretin hormones and insulin, and reduce appetite and glycaemia after a standardised meal, and that these effects are sustained over 12 weeks; (ii) will induce greater reduction in HbA1c in subjects with more rapid gastric emptying at baseline; (iii) is not associated with weight gain, due to “compensation” for the increased protein load; and (iv) will reduce HbA1c independently of changes in insulin resistance, weight, or body composition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51990 0
A/Prof Chris Rayner
Address 51990 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 51990 0
Australia
Phone 51990 0
+61 8 82222916
Fax 51990 0
Email 51990 0
chris.rayner@adelaide.edu.au
Contact person for public queries
Name 51991 0
A/Prof Chris Rayner
Address 51991 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 51991 0
Australia
Phone 51991 0
+61 8 82222916
Fax 51991 0
Email 51991 0
chris.rayner@adelaide.edu.au
Contact person for scientific queries
Name 51992 0
A/Prof Chris Rayner
Address 51992 0
Discipline of Medicine Royal Adelaide Hospital North Terrace Adelaide SA 5000
Country 51992 0
Australia
Phone 51992 0
+61 8 82222916
Fax 51992 0
Email 51992 0
chris.rayner@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA whey/guar "preload" improves postprandial glycaemia and glycated haemoglobin levels in type 2 diabetes: A 12-week, single-blind, randomized, placebo-controlled trial.2019https://dx.doi.org/10.1111/dom.13604
EmbaseThe 'early' postprandial glucagon response is related to the rate of gastric emptying in type 2 diabetes.2023https://dx.doi.org/10.1016/j.peptides.2023.170941
Dimensions AISerum alanine transaminase is predictive of fasting and postprandial insulin and glucagon concentrations in type 2 diabetes2023https://doi.org/10.1016/j.peptides.2023.171092
N.B. These documents automatically identified may not have been verified by the study sponsor.