None listed
Conditions
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.
Interventions
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 eithe
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.
Sponsors
Curtin University of Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Overweight or obese (BMI between 25-40 kg/m2)
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.
Outcome results
None listed