Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001251819
Ethics application status
Approved
Date submitted
26/11/2012
Date registered
27/11/2012
Date last updated
23/10/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of protein/fibre drinks on glucose control in people with type 2 diabetes
Scientific title
The effect of protein/fibre drinks on blood glucose control in people with type 2 diabetes
Secondary ID [1] 281586 0
Nil
Universal Trial Number (UTN)
U1111-1137-2983
Trial acronym
PROGRESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 287868 0
Condition category
Condition code
Metabolic and Endocrine 288232 288232 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial aims to show that a drink containing protein and a mix of protein and soluble fibre (guar) slows starch hydrolysis and absorption of glucose. The study consists of 2 phases: acute and chronic. Acute study: Participants will attend the research centre at 9am on 5 consecutive weekdays (Mon - Fri), having fasted overnight for 12 hours. On the first test day a continuous glucose monitor will be inserted. It will remain in place for 7 full days and calibrated daily using fingerprick glucoses 4 times/day. On each test day participants will be fed a morning meal consisting of either: (i) 4 slices of white bread with no spreads; (ii) 2 slices (women) or 3 slices (men) of white bread with jam and margarine; (iii) cereal with milk. Tea or coffee with optional sugar and/milk is optional for breakfasts (ii) and (iii). All participants will have each breakfast option twice over the course of 6 consecutive days such that the final meal test will be completed at home unsupervised (food supplied). For each breakfast type (i.e. (i), (ii) or (iii)) on one of the two occasions the breakfast will be preceeded by 150ml of water (control) and on the other occasion preceeded by a 150ml drink containing 20g protein plus 5 g guar (treatment). The drink (control or treatment) will be taken 15 minutes before consuming the breakfast. As such, the 2 occasions for each breakfast type will be conducted in a crossover fashion on two consecutive days with no washout period between the treatment and control occasion for a given type of breakfast. The tests will be performed with 70 volunteers, with randomisation to the order that the treatment or control is given for each type of breakfast meal. Participants are required to keep a log of medication, physical activity and carbohydrate foods consumed during the 7 day period. However, on the last day of wearing the continuous glucose monitor (Sunday) participants can elect not to fill out logs and can eat their normal breakfast. The monitor is removed on the next day (Monday). Participants over the age of 55 will also be given the option to remain in the clinic for 3 hours post-meal on any two days (of the same type of breakfast meal) to have their blood pressure monitored using an ambulatory blood pressure monitor. Chronic study: Following on from the acute study, 140 participants will be randomised to receive the control (no shake mixture provided) or treatment (shake mixture provided) in either the first period (0-3 months) or second period (3-6 months). The treatment group only will be provided with the treatment drink (shake powder) to take home and self-administer with water on a daily basis 15 minutes before breakfast for 6 months. To ensure the shake is effective in the short term in a given participant, participants for the chronic study will first be tested on two consecutive days using breakfast option (i) above and randomised in a crossover fashion on two consecutive days (i.e. no wahout) such that they will receive the treatment (shake) or control (water) 15 minutes prior to the breakfast meal each once on one of the two days. Post-prandial blood glucose levels will once again be measured with a continuous monitor that will be worn for 48 hours. Participants may be enrolled in the acute or chronic study, or both. Participants who have already completed the acute study and shown a good response will not need to undergo the meal test for the chronic study.
Intervention code [1] 286111 0
Treatment: Other
Intervention code [2] 286112 0
Lifestyle
Comparator / control treatment
For the acute study (and for the meal test for the chronic study): 150 ml of water will be given as a control prior to the breakfast in place of the treatment drink. For the chronic study: participants will be randomised to receive the control (no shake mixture provided) or treatment (shake mixture provided) in either the first period (0-3 months) or second period (3-6 months).
Control group
Active

Outcomes
Primary outcome [1] 288422 0
Acute study: Mean reduction in post-prandial blood glucose levels (mmol) measured using a continuous glucose monitor worn by the participant.
Timepoint [1] 288422 0
Within the 24 h following morning test meal during intervention period
Primary outcome [2] 288423 0
Chronic study: Mean reduction in HbA1c (%) measured using fasting venous blood samples
Timepoint [2] 288423 0
At 3 individual time points: baseline, 3 months and 6 months.
Secondary outcome [1] 300113 0
Mean increase or decrease in systolic and diastolic blood pressure (mmHg) measured using an ambulatory blood pressure monitor
Timepoint [1] 300113 0
Within the 3 hours following the breakfast meal during the intervention period

Eligibility
Key inclusion criteria
Diagnosed with type 2 diabetes
On oral hypoglycemic medication or no medication for diabetes
HbA1c reading of >7.0% within the last 6 months
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Taking insulin
Pregnant or lactating women
Previous bariatric surgery

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)
Both the researcher who determined if the subject was eligible for inclusion in the trial, and the subject, were not aware if the subject would be allocated to the treatment or the control on a given day (acute study) or to the treatment or control group (chronic study). Allocation was centrally performed by computer software.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Note: For the chronic study, the control and treatment groups will be run in parallel, not as a crossover.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/12/2012
Actual
4/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286383 0
Government body
Name [1] 286383 0
Commercialisation Australia
Country [1] 286383 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Omniblend
Address
4 - 8 Capital Link Drive
Campbellfield, VIC 3061
Country
Australia
Secondary sponsor category [1] 285171 0
Charities/Societies/Foundations
Name [1] 285171 0
Baker IDI Heart & Diabetes Institute
Address [1] 285171 0
75 Commercial Rd
Prahran
VIC 3181
Country [1] 285171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288453 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 288453 0
Ethics committee country [1] 288453 0
Australia
Date submitted for ethics approval [1] 288453 0
Approval date [1] 288453 0
24/10/2012
Ethics approval number [1] 288453 0
1/12/0416

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34982 0
Prof Peter Clifton
Address 34982 0
P5-16 Playford Building
University of South Australia, City East Campus
70 North Terrace,
Adelaide SA 5000
Country 34982 0
Australia
Phone 34982 0
+61884629702
Fax 34982 0
Email 34982 0
[email protected]
Contact person for public queries
Name 18229 0
Peter Clifton
Address 18229 0
GPO Box 664 Adelaide SA 5001
Country 18229 0
Australia
Phone 18229 0
+61884629702
Fax 18229 0
Email 18229 0
[email protected]
Contact person for scientific queries
Name 9157 0
Peter Clifton
Address 9157 0
GPO Box 664 Adelaide SA 5001
Country 9157 0
Australia
Phone 9157 0
+61884629702
Fax 9157 0
Email 9157 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
SourceTitleYear of PublicationDOI
EmbaseEffect of a low dose whey/guar preload on glycemic control in people with type 2 diabetes-a randomised controlled trial.2014https://dx.doi.org/10.1186/1475-2891-13-103
N.B. These documents automatically identified may not have been verified by the study sponsor.