Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000831684
Ethics application status
Approved
Date submitted
28/07/2014
Date registered
5/08/2014
Date last updated
5/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a protein ‘preload’ on glycaemia and gastric emptying over 4 weeks in patients with type 2 diabetes
Scientific title
A randomized, single-blind, cross-over trial to evaluate the effects of a protein ‘preload’ compared to placebo on glycaemia and gastric emptying over 4 weeks in patients with type 2 diabetes
Secondary ID [1] 285068 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 292597 0
Condition category
Condition code
Diet and Nutrition 292899 292899 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 292946 292946 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
25g whey protein in a chocolate flavoured drink (or control) taken as a 'preload', 30 min before meals, three times daily, for 4 weeks. Adherence will be monitored by a daily diary with checkboxes to fill in on taking the preload, and by weekly telephone calls.There will be a 2 week 'washout' period before crossing over to the alternate intervention (control or whey protein).
Intervention code [1] 289906 0
Treatment: Other
Comparator / control treatment
'Diet' chocolate flavoured drink without whey protein.
Control group
Placebo

Outcomes
Primary outcome [1] 292773 0
Postprandial blood glucose concentrations following a potato meal taken at the beginning and end of 4 weeks intervention.
Timepoint [1] 292773 0
0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min after the meal
Secondary outcome [1] 309649 0
Gastric emptying of a potato meal taken at the beginning and end of 4 weeks intervention, measured by scintigraphy.
Timepoint [1] 309649 0
Images taken every 15 min after the meal for 240 min.
Secondary outcome [2] 309650 0
Fructosamine concentration in serum
Timepoint [2] 309650 0
Measured at the beginning and end of the active and placebo intervention periods.
Secondary outcome [3] 309651 0
Glycated haemoglobin in serum
Timepoint [3] 309651 0
Measured at the beginning and end of the active and placebo intervention periods.

Eligibility
Key inclusion criteria
Patients with type 2 diabetes managed by diet alone
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant medical disorders (other than diabetes);
2. Significant gastrointestinal symptoms or history of gastrointestinal surgery (other than appendicectomy or cholecystectomy);
3. Intake of >20 g alcohol on a daily basis or cigarette smoking;
4. Current use of medications which may affect gastrointestinal function or appetite (e.g. prokinetic drugs, orlistat, tricyclic antidepressants);
5. Current pregnancy or lactation;
6. Inability to prepare meals, or meet dietary requirements, (including frequent dining out (>2x/week)) and widely fluctuating exercise patterns;
7. Inability or unwillingness to perform capillary blood glucose monitoring;
8. Exposure to radiation as part of a research study in the preceding 12 months.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/10/2007
Date of last participant enrolment
Anticipated
Actual
24/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289674 0
Charities/Societies/Foundations
Name [1] 289674 0
Diabetes Australia Research Trust
Country [1] 289674 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 288366 0
None
Name [1] 288366 0
Address [1] 288366 0
Country [1] 288366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291410 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 291410 0
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 291410 0
Australia
Date submitted for ethics approval [1] 291410 0
Approval date [1] 291410 0
26/07/2007
Ethics approval number [1] 291410 0
RAH protocol number 060823

Summary
Brief summary
Patients are randomised to receive 4 weeks treatments with a 25g whey protein 'preload' taken 30 min before each of the 3 main meals daily for 4 weeks, or placebo. After a 2 week 'washout' period, they cross over to the alternate treatment. They will attend the hospital for a test meal of radiolabelled mashed potato at the beginning and end of each intervention period, to evaluate whether the capacity of the protein preload to lower blood glucose concentrations and slow gastric emptying after the meal are sustained over 4 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50262 0
A/Prof Chris Rayner
Address 50262 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 50262 0
Australia
Phone 50262 0
+61 8 82222916
Fax 50262 0
Email 50262 0
[email protected]
Contact person for public queries
Name 50263 0
A/Prof Chris Rayner
Address 50263 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 50263 0
Australia
Phone 50263 0
+61 8 82222916
Fax 50263 0
Email 50263 0
[email protected]
Contact person for scientific queries
Name 50264 0
A/Prof Chris Rayner
Address 50264 0
Discipline of Medicine
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 50264 0
Australia
Phone 50264 0
+61 8 82222916
Fax 50264 0
Email 50264 0
[email protected]

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
No additional documents have been identified.