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Trial registered on ANZCTR


Registration number
ACTRN12617000960358
Ethics application status
Approved
Date submitted
29/06/2017
Date registered
4/07/2017
Date last updated
23/01/2019
Date data sharing statement initially provided
23/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Fibre supplementation to decrease hunger, improve chronic disease risk factors and weight loss in overweight and obese children.
Scientific title
PGX® supplementation to improve satiety, glucose, HbA1c, lipid status and weight loss in overweight and obese children.
Secondary ID [1] 292271 0
None
Universal Trial Number (UTN)
U1111-1198-3341
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic risk factors 303862 0
Cardiovascular risk factors 303889 0
Overweight/obesity 303890 0
Condition category
Condition code
Diet and Nutrition 303254 303254 0 0
Obesity
Metabolic and Endocrine 303255 303255 0 0
Metabolic disorders
Cardiovascular 303256 303256 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, double blind, parallel design study over a 16-week period. The intervention will consist of 2 x 5g sachets (total daily dose) of PGX® (Alginate-konjac-xanthan polysaccharide complex) (InovoBiologic, Inc., Calgary, Canada) in a granulated form. Participants will only take half of each sachet (2 x 2.5g) for a week before taking the full dose to allow time to adjust to the supplement. Participants will be instructed to mix 5g of the PGX® powder with either 250 mL of milk or 175 g of yogurt, twice daily (in place of two serves of dairy in participants’ usual diets), 5-10 minutes before meals (breakfast and dinner). In addition, each child should consume at least 250 mL water after taking the supplement.

Adherence will be monitored by sachet return.
Intervention code [1] 298494 0
Treatment: Other
Comparator / control treatment
Control participants will consume the placebo with their usual diet. The placebo will consist of 5g sachets of rice flour taken 2 times a day. Participants will be instructed to mix either 5 g rice flour (placebo) with either 250 mL of milk or 175 g of yogurt, twice daily (in place of two serves of dairy in participants’ usual diets), 5-10 minutes before meals (breakfast and dinner). In addition, each child should consume at least 250 mL water after taking the supplement.

Adherence will be monitored by sachet return.
Control group
Placebo

Outcomes
Primary outcome [1] 302596 0
BMI-for-age z-scores (WHO) will be calculated from body weight and height.

Timepoint [1] 302596 0
Baseline, week 8 and week 16 (primary endpoint)
Primary outcome [2] 302597 0
Lipid concentrations from fasting blood tests using point of care device (Samsung LabGeo PT10)
Timepoint [2] 302597 0
Baseline and week 16
Primary outcome [3] 302631 0
HbA1c concentrations from fasting blood tests using point of care device (A1CNow+)
Timepoint [3] 302631 0
Baseline and week 16
Secondary outcome [1] 336466 0
Satiety measured by 100 mm Visual analogue scales
Timepoint [1] 336466 0
Baseline, week 8 and week 16.
Participants will be instructed to complete the VAS before and after the meal at baseline and before taking the supplement, after taking the supplement but before the meal and after the meal at 8 and 16 weeks.
Secondary outcome [2] 336467 0
Blood pressure measured by automated, calibrated sphygmomanometer.
Timepoint [2] 336467 0
Baseline, week 8 and week 16
Secondary outcome [3] 336468 0
Arterial stiffness will be assessed by pulse contour analysis using the Pulse Trace PCA 2
Timepoint [3] 336468 0
Baseline, week 8 and week 16
Secondary outcome [4] 336564 0
Glucose concentrations from fasting blood tests using point of care device (Samsung LabGeo PT10) This outcome is primary.
Timepoint [4] 336564 0
Baseline and week 16
Secondary outcome [5] 336565 0
BMI will be calculated by weight in kg divided by height in m squared.
Timepoint [5] 336565 0
Baseline, week 8 and week 16 (primary endpoint).
Secondary outcome [6] 336566 0
Body composition as measured by the Impedimed DF50.
Timepoint [6] 336566 0
Baseline, week 8 and week 16 (primary endpoint).
Secondary outcome [7] 336567 0
Waist circumference will be measured in the standing position at the narrowest area between the lateral lower rib and the iliac crest.
Timepoint [7] 336567 0
Baseline, week 8 and week 16 (primary endpoint).
Secondary outcome [8] 336568 0
Hip circumference will be taken at the largest circumference of the lower abdomen.
Timepoint [8] 336568 0
Baseline, week 8 and week 16 (primary endpoint).
Secondary outcome [9] 336569 0
Height will be measured to the nearest 0.1 cm using a stadiometer (26SM 200cm Seca, Hamburg, Germany) without shoes.
Timepoint [9] 336569 0
Baseline, week 8 and week 16 (primary endpoint).
Secondary outcome [10] 366117 0
Gut microbiome (possible future testing by faecal assay pending further funding)
Timepoint [10] 366117 0
Baseline and week 16

Eligibility
Key inclusion criteria
Overweight and obese children with a body mass index (BMI) above the 85th percentile of growth charts (WHO BMI for age percentile, approx. BMI 25-35) for age and sex, who are aged between 9-13 years.
Minimum age
9 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include medications and conditions that influence appetite or metabolism, use of steroids and other agents or medications that may influence lipid metabolism, use of warfarin, diabetes, hypo- and hyperthyroidism, cardiovascular events within in the last 6 months, psychological unsuitability, major systemic diseases, gastrointestinal problems (including difficulty swallowing), dairy allergies (eg. lactose intolerance), proteinuria, liver or renal failure, vegetarianism, passive smoking, substance abuse, and use of fibre supplements.

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)
Trial funders will carry out randomisation and supply numbered supplement packages with the allocation unknown by researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation sequence created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
An a priori sample size estimate indicated that 50 children (25 per arm) would provide at least 80% power at the 5% level of significance (two-sided) to detect a 0.4 unit difference in change of zBMI from baseline to 16 weeks between the intervention and control groups, assuming a standard deviation of 0.5. Recruiting a total of 70 participants (35 participants per group) will accommodate for 25% dropouts (an average dropout rate for similar studies in adults, as it will be participants’ parents/guardians that will be responsible for study compliance).

To account for variations in weight across the age spectrum, BMI-for-age z-scores will also be analysed, as recommended by the World Health Organisation. If the data meet the required assumptions for General Linear Models (eg. normal distribution etc), BMI-for-age z-scores can be analysed using ANCOVA, to control for sex and physical activity, using the baseline BMI-for-age z-scores as a covariate. If the data do not meet to the required assumptions, analysis of covariance can be conducted through General Linear Mixed Models, which accommodates violations in assumptions and can be conducted with small sample sizes and will be determined when the dataset is complete. Statistical analysis will be undertaken using SPSS 24 for Windows (SPSS Inc., Chicago, IL). Data will be expressed as mean (±SEM) and assessed for normality to ensure that the assumptions of the analysis are met. The data will be analysed using independent samples t-test. Statistical significance will be considered at p <0.05.

Recruitment
Recruitment status
Recruiting
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] 296817 0
Commercial sector/Industry
Name [1] 296817 0
Factors Group Australia
Address [1] 296817 0
10 South Street
Rydalmere NSW 2116
Country [1] 296817 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 295807 0
None
Name [1] 295807 0
Address [1] 295807 0
Country [1] 295807 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298087 0
Curtin University HREC
Ethics committee address [1] 298087 0
GPO Box U1987
Perth WA 6845
Ethics committee country [1] 298087 0
Australia
Date submitted for ethics approval [1] 298087 0
17/07/2017
Approval date [1] 298087 0
10/04/2018
Ethics approval number [1] 298087 0
HRE2018-0234

Summary
Brief summary
Aims: The aim of this study is to examine the effect of PolyGlycopleX® (PGX®) supplementation on metabolic risk factors in overweight and obese children.

Background: The number of overweight children in Australia, Canada and the US has doubled in recent years, with a third considered either overweight or obese. There is considerable evidence childhood obesity can result in orthopaedic complications, sleep apnoea and hepatic steatosis, cardiovascular disease risk factors, type 2 diabetes and psychosocial problems, including low self-esteem and depression. Childhood obesity usually progresses into adulthood, leading to earlier development of chronic diseases such as type 2 diabetes. As a consequence, early interventions in overweight children are required urgently.
High-fibre intake has been shown to reduce the risk of metabolic syndrome, cardiovascular disease and type 2 diabetes in adults. Studies in adults have demonstrated that fibre supplementation can benefit many components of the metabolic syndrome (MS) such as glucose levels and insulin response, blood pressure, as well as lipid profile, thereby reducing chronic disease. However, the effect of fibre supplementation on MS components in children is currently unknown. Supplementation with the novel viscous polysaccharide PGX® (a listed medicine with the TGA, with the active ingredient known as Alginate-konjac-xanthan polysaccharide complex) in adults has shown beneficial effects on weight gain, satiety, lipids, glycaemic response and insulin sensitivity but there have been no studies on the effects in children.
Therefore, the aim of this study is to investigate the role of 5g PGX® supplementation (orange flavoured powder added to water) compared to a placebo, for 16 weeks on fasting glucose, HbA1c, lipids, BMI for age percentile, body composition and satiety in overweight/obese children aged 9-13 years.

Collectively, PGX® supplementation could be promoted to overweight and obese children as an aid to weight loss and management by increasing satiety and suppressing excess food intake. Therefore, a simple strategy of PGX® supplementation may offer an easy solution to improvements in metabolic syndrome in children without the need for other nutrient modification.

Study Proposal: Seventy overweight and obese children will consume 10g PGX® or placebo supplement (as a divided dose of 5g) for 16 weeks. Fasting measurements of various metabolic risk factors such as glucose, glycated haemoglobin (HbA1c) and lipids will be taken at 0 and 16 weeks. Height, body weight, body composition, waist, hip, blood pressure, arterial stiffness and satiety will be measured at 0, 8 and 16 weeks
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75830 0
A/Prof Sebely Pal
Address 75830 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 75830 0
Australia
Phone 75830 0
+61 8 9266 4755
Fax 75830 0
Email 75830 0
s.pal@curtin.edu.au
Contact person for public queries
Name 75831 0
A/Prof Sebely Pal
Address 75831 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 75831 0
Australia
Phone 75831 0
+61 8 9266 4755
Fax 75831 0
Email 75831 0
s.pal@curtin.edu.au
Contact person for scientific queries
Name 75832 0
A/Prof Sebely Pal
Address 75832 0
School of Public Health
Curtin University
GPO Box U1987
Perth WA 6845
Country 75832 0
Australia
Phone 75832 0
+61 8 9266 4755
Fax 75832 0
Email 75832 0
s.pal@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD sharing was not considered at trial inception.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable