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Trial registered on ANZCTR


Registration number
ACTRN12611000415909
Ethics application status
Approved
Date submitted
20/04/2011
Date registered
20/04/2011
Date last updated
20/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of two different fibre supplements on body weight, body composition, metabolic and cardiovascular risk factors in overweight and obese individuals.
Scientific title
Overweight and obese individuals and the comparison of two different fibre supplements on body weight, body composition, metabolic and cardiovascular risk factors.
Secondary ID [1] 260026 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic and cardiovascular risk factors. 265685 0
Condition category
Condition code
Public Health 265823 265823 0 0
Health promotion/education
Diet and Nutrition 265849 265849 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, double blind, parallel design study over a 52 week period. Study participants will be randomised into one of three groups: the control group who will consume the placebo with their usual diet; the psyllium supplement group who will consume a psyllium supplement with their usual diet, and a PolyGlycopleX (PGX) supplement group who will consume a PGX supplement with their usual diet. The fibre supplementation will consist of 5g of either psyllium Metamucil or 5g of either PGX (InovoBiologic, Inc., Calgary, Canada). Placebo will consist of 5g rice flour with flavouring. The rice flour will provide an appropriate placebo due to its low energy and fibre content and similarity in texture and appearance to the psyllium and PGX supplement. Participants will be instructed to take either 5g of the fibre supplements or placebo, mixed with 250mL water, three times daily 5-10 minutes before breakfast, lunch and dinner. Extra water may be taken ad libitum during or after the meal if desired and subjects will be made aware of this.
Intervention code [1] 264446 0
Treatment: Other
Comparator / control treatment
Control participants will consume the placebo with their usual diet. The placebo will consist of 5g rice flour with flavouring.
Control group
Placebo

Outcomes
Primary outcome [1] 266582 0
Body weight. Body weight (UM-018 Digital Scales, Tanita Corporation, Tokyo, Japan) will be recorded in light clothing without shoes.
Timepoint [1] 266582 0
baseline, 4, 8, 12, 16, 20, 26, 32, 38, 44, and 52 weeks.
Primary outcome [2] 266583 0
Body composition measured by whole body dual-energy X-ray absorptiometry (DEXA; Lunar Prodigy)
Timepoint [2] 266583 0
baseline, 26 weeks and 52 weeks
Primary outcome [3] 266584 0
Lipids, glucose and insulin levels, measured from fasting blood samples.
Timepoint [3] 266584 0
baseline, 12 weeks, 26 weeks and 52 weeks
Secondary outcome [1] 276064 0
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) measured on the left arm of participants with an automated sphygmomanometer (Dinamap ProCare). Subjects rested in a supine position before and during measurements.
Timepoint [1] 276064 0
baseline, 4, 8, 12, 16, 20, 26, 32, 38, 44, and 52 weeks.
Secondary outcome [2] 276065 0
Waist and Hip circumferences. Waist circumference will be measured in the standing position at the narrowest area between the lateral lower rib and the iliac crest. Hip measurement will be taken at the largest circumference of the lower abdomen.
Timepoint [2] 276065 0
baseline, 4, 8, 12, 16, 20, 26, 32, 38, 44, and 52 weeks.

Eligibility
Key inclusion criteria
Overweight or obese (BMI between 25-40 kg/m2)
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking, lipid lowering medication, use of steroids and other agents that may influence lipid metabolism, use of warfarin, diabetes mellitus, hypo- and hyperthyroidism, cardiovascular events within the last 6 months, major systemic diseases, gastrointestinal problems, proteinuria, liver, renal failure, weight fluctuations over the past 6 months and vegetarianism.

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)
Potential participants will be screened by telephone and attend a briefing to assess suitability. Suitable participants will be allocated to a group by c. central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer program generated randomization plan.
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)
WA

Funding & Sponsors
Funding source category [1] 264920 0
Commercial sector/Industry
Name [1] 264920 0
Invovo Biologic
Address [1] 264920 0
104-1240 Kensington Rd N.W., Suite 409
Calgary, Alberta
Canada
Y2N 4Y7
Country [1] 264920 0
Canada
Primary sponsor type
University
Name
Curtin University of Technology
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 264019 0
None
Name [1] 264019 0
Address [1] 264019 0
Country [1] 264019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266877 0
Curtin University Human Ethics Committee
Ethics committee address [1] 266877 0
GPO Box U1987
Perth WA 6845
Ethics committee country [1] 266877 0
Australia
Date submitted for ethics approval [1] 266877 0
17/03/2011
Approval date [1] 266877 0
23/11/2011
Ethics approval number [1] 266877 0
HR41/2011

Summary
Brief summary
The current dietary fibre recommendations are 25–30 g/day, given the benefits of higher fibre intakes on lower body weight, BMI, waist circumference, improved plasma lipid profiles, improved glycaemia/ insulinaemia and risk reduction for metabolic syndrome, CVD and type 2 diabetes. However, most Australians, Canadians and Americans do not meet the recommendations because most find it difficult to consume enough fruit, vegetables, legumes and whole grains through their daily diet. Therefore, using fibre supplements may be an alternative way to increase daily fibre intakes.

A simple strategy of PGX fibre supplementation may offer an easier solution to long-term weight loss and then management as well as improvements in metabolic syndrome without the need for other nutrient modification. The effects of PGX supplementation may be better than that of psyllium due to its higher viscosity levels and its effects on postprandial glucose/insulin. Therefore, the results from this trial have the potential to provide the necessary scientific evidence required to endorse the use of PGX supplementation, over psyllium in the dietary management (prevention and treatment) of chronic diseases.
Trial website
Trial related presentations / publications
Effect on body weight and composition in overweight/obese Australian adults over 12 months consumption of two different types of fibre supplementation in a randomized trial.
Pal S, Ho S, Gahler RJ, Wood S.
Nutr Metab (Lond). 2016 Nov 17;13:82.

Effect on Insulin, Glucose and Lipids in Overweight/Obese Australian Adults of 12 Months Consumption of Two Different Fibre Supplements in a Randomised Trial.
Pal S, Ho S, Gahler RJ, Wood S.
Nutrients. 2017 Jan 29;9(2). pii: E91. doi: 10.3390/nu9020091.
Public notes

Contacts
Principal investigator
Name 32511 0
A/Prof Sebely Pal
Address 32511 0
School of Public Health Curtin University GPO Box U1987 Perth WA 6845
Country 32511 0
Australia
Phone 32511 0
+61 8 9266 4755
Fax 32511 0
Email 32511 0
s.pal@curtin.edu.au
Contact person for public queries
Name 15758 0
A/Prof Assoc Prof Sebely Pal
Address 15758 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 15758 0
Australia
Phone 15758 0
+61 8 9266 4755
Fax 15758 0
Email 15758 0
s.pal@curtin.edu.au
Contact person for scientific queries
Name 6686 0
A/Prof Assoc Prof Sebely Pal
Address 6686 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 6686 0
Australia
Phone 6686 0
+61 8 9266 4755
Fax 6686 0
Email 6686 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