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Trial registered on ANZCTR


Registration number
ACTRN12609000540213
Ethics application status
Approved
Date submitted
2/07/2009
Date registered
6/07/2009
Date last updated
6/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The chronic effects of dietary fibre on metabolic syndrome risk factors in overweight and obese individuals.
Scientific title
The chronic effects of dietary fibre on metabolic syndrome risk factors in overweight and obese individuals.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic risk factors in overweight and obese individuals 237138 0
Condition category
Condition code
Diet and Nutrition 237462 237462 0 0
Obesity
Cardiovascular 237468 237468 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chronic, randomized, parallel design study over 12 weeks, with 4 intervention groups: 1-placebo
2-fibre supplement (12grams of psyllium, three times daily for a total of 12 weeks; mixed with water and taken before breakfast, lunch and dinner)
3-Healthy eating plan according to the Australian Dietary guidelines (ad libitum (followed according to the participant's discretion) healthy eating plans for all meals and snacks for 12 weeks, was based on the dietary guidelines for Australian adults (2002).
4-fibre supplement (psyllium) plus Healthy eating plan according to the Australian Dietary guidelines
Intervention code [1] 236855 0
Treatment: Other
Comparator / control treatment
The placebo consisted of breadcrumbs plus flavouring (12grams of bread crumbs was taken three times daily for a total of 12 weeks; mixed with water and taken before breakfast, lunch and dinner)
Control group
Placebo

Outcomes
Primary outcome [1] 238269 0
Improved fasting blood lipid, lipoprotein profile, glucose and insulin response was measured by blood analysis.
Timepoint [1] 238269 0
Fasting blood samples taken at 0, 6 and 12 weeks. Analysis of lipids, lipoproteins, glucose and lipids were conducted using different biochemical kits.
Primary outcome [2] 238270 0
Improved blood pressure after 12 weeks. Blood pressure will be measured by research assistant using Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured on the left arm of participants with an automated sphygmomanometer (Dinamap ProCare). Subjects will be rested in a supine position before and during measurements.
Timepoint [2] 238270 0
Measured at 0, 6 and 12 weeks
Secondary outcome [1] 244637 0
Improved vascular endothelium function via Sphygmocor pulse wave analysis (PWA)
Timepoint [1] 244637 0
Measured at 0, 6 and 12 weeks

Eligibility
Key inclusion criteria
Body Mass Index (BMI) between 25 40kg/m2
Healthy
Not on regular medications
Non-smoker
No major diseases or disorders
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking
Medications - lipid lowering, steroids, warfarin, blood pressure
Diabetes
Thyroid dysfunction
Cardiovascular events in previous 6 months
Psychological unsuitability
Major systemic diseases
GI problems
Liver disease
Kidney dysfunction

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)
Numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237246 0
Self funded/Unfunded
Name [1] 237246 0
Address [1] 237246 0
Country [1] 237246 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 236733 0
None
Name [1] 236733 0
Address [1] 236733 0
Country [1] 236733 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239349 0
Curtin University
Ethics committee address [1] 239349 0
GPO Box U1987 Perth WA 6845
Ethics committee country [1] 239349 0
Australia
Date submitted for ethics approval [1] 239349 0
Approval date [1] 239349 0
12/01/2005
Ethics approval number [1] 239349 0
157/2004

Summary
Brief summary
The prevalence of overweight/obesity is currently exploding with over 60% of Australian adults in this category, leading to a rapid increase in diabetes, hypertension, and cardiovascular disease (CVD). There is evidence that adding fibre to the diet can improve cardiovascular and diabetes related risk factors although there is little research on fibre consumed as a supplement with both a normal diet and a healty diet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29833 0
Address 29833 0
Country 29833 0
Phone 29833 0
Fax 29833 0
Email 29833 0
Contact person for public queries
Name 13080 0
Assoc Prof Sebely Pal
Address 13080 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 13080 0
Australia
Phone 13080 0
+61 8 9266 4755
Fax 13080 0
+61 8 9266 2958
Email 13080 0
s.pal@curtin.edu.au
Contact person for scientific queries
Name 4008 0
Assoc Prof Sebely Pal
Address 4008 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 4008 0
Australia
Phone 4008 0
+61 8 9266 4755
Fax 4008 0
+61 8 9266 2958
Email 4008 0
s.pal@curtin.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary