Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000828628
Ethics application status
Approved
Date submitted
24/07/2014
Date registered
5/08/2014
Date last updated
5/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gastrointestinal determinants of vascular risk in healthy humans
Scientific title
A randomised crossover trial of the effect of adding guar gum to meals or prolonging meal duration on postprandial flow mediated dilatation in healthy humans
Secondary ID [1] 285044 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 292557 0
Condition category
Condition code
Diet and Nutrition 292866 292866 0 0
Other diet and nutrition disorders
Cardiovascular 292867 292867 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each of 3 meals will be administered once, with at least 2 days between each. For 'meal 1', the mashed potato meal will be consumed over 10 min. For 'meal 2', 9g guar gum will be added to the mashed potato meal, and consumed over 10 min. For 'meal 3', the mashed potato meal will be consumed over 60 min.
Intervention code [1] 289879 0
Prevention
Comparator / control treatment
Mashed potato meal without guar gum consumed within 10 min
Control group
Placebo

Outcomes
Primary outcome [1] 292738 0
Change in flow mediated dilatation from baseline using brachial artery ultrasound
Timepoint [1] 292738 0
30, 60, 90, and 120 min after the meal
Secondary outcome [1] 309582 0
Blood glucose concentrations
Timepoint [1] 309582 0
0, 15, 30, 60, 90 120, 180, and 240 min after the meal
Secondary outcome [2] 309583 0
Serum insulin concentrations
Timepoint [2] 309583 0
0, 15, 30, 60, 90 120, 180, and 240 min after the meal
Secondary outcome [3] 309584 0
Breath test for measurement of gastric emptying
Timepoint [3] 309584 0
0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, and 240 min after the meal

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of gastrointestinal surgery (except appendicectomy)
History of cerebral haemorrhage or head trauma
Hypertrophic obstructive cardiomyopathy, or aortic or mitral valve stenosis
Medication which may affect gastrointestinal motor function or phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, or vardenafil)
Other significant illness, including epilepsy, cardiovascular or respiratory disease
Evidence of drug abuse, consumption of more than 20 g alcohol on a daily basis, or smoking.

Study design
Purpose of the study
Prevention
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)
The order of the meals will be determined by computer-generated random number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
17/07/2012
Date of last participant enrolment
Anticipated
Actual
31/05/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289655 0
Government body
Name [1] 289655 0
National Health and Medical Research Council of Australia
Country [1] 289655 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 288344 0
None
Name [1] 288344 0
Address [1] 288344 0
Country [1] 288344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291391 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 291391 0
North Terrace
Adelaide SA 5000
Ethics committee country [1] 291391 0
Australia
Date submitted for ethics approval [1] 291391 0
Approval date [1] 291391 0
18/04/2012
Ethics approval number [1] 291391 0
RAH protocol number 080511c

Summary
Brief summary
The aim of the trial is to examine the hypothesis that dietary interventions, which slow gastric emptying and/or the rate of carbohydrate absorption, will be associated with a corresponding reduction in the decline in endothelial dysfunction that is observed after meals.
Subjects will be studied on 3 occasions in random order, after an overnight fast. They will consume a 13C-octanoic acid labelled mashed potato meal ('meal 1'), or the same meal mixed with 9 g guar ('meal 2') within 10 min, or 'meal 1' divided into 12 equal portions over 60 min ('meal 3'). Brachial artery flow mediated dilatation will be measured every 30 min for 120 min, breath samples will be collected to evaluate gastric emptying, and blood will be sampled to measure blood glucose and serum insulin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50166 0
A/Prof Chris Rayner
Address 50166 0
Discipline of Medicine, Royal Adelaide Hospital, North Terrace Adelaide SA 5000
Country 50166 0
Australia
Phone 50166 0
+61 8 82222916
Fax 50166 0
Email 50166 0
chris.rayner@adelaide.edu.au
Contact person for public queries
Name 50167 0
A/Prof Chris Rayner
Address 50167 0
Discipline of Medicine, Royal Adelaide Hospital, North Terrace Adelaide SA 5000
Country 50167 0
Australia
Phone 50167 0
+61 8 82222916
Fax 50167 0
Email 50167 0
chris.rayner@adelaide.edu.au
Contact person for scientific queries
Name 50168 0
A/Prof Chris Rayner
Address 50168 0
Discipline of Medicine, Royal Adelaide Hospital, North Terrace Adelaide SA 5000
Country 50168 0
Australia
Phone 50168 0
+61 8 82222916
Fax 50168 0
Email 50168 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
No additional documents have been identified.