None listed
Conditions
Brief summary
This study is a randomised controlled open labelled pilot trial. The research study aims to explore the effect of fibre and antioxidant supplementation on values of inflammation found in blood and the microbiome on older adults living in the community aged 60-70 years old. This pilot trial is significant because the researchers hope the results of this trial will provide initial evidence of the effect of nutritional supplements on the health status of older Australians especially in relation to nutrition, inflammation and frailty.
Interventions
164 patients will be randomised to one of 4 groups (1:1:1:1) to receive:
- Bioceuticals Prebiome Fibre only (5g powder/twice per day) (Group A) for 16 weeks;
We advise to mix this product into food such as a smoothie, yoghurt, cereal, porridge or mashed fruit. Please also drink 250ml of water close to the same time as taking the Prebiome Fibre supplement. Please make sure that you drink at least 1500ml of fluid per day of which 500 ml is water.
- Blackmores Grapeseed Forte only (2 tablets/
164 patients will be randomised to one of 4 groups (1:1:1:1) to receive: - Bioceuticals Prebiome Fibre only (5g powder/twice per day) (Group A) for 16 weeks; We advise to mix this product into food such as a smoothie, yoghurt, cereal, porridge or mashed fruit. Please also drink 250ml of water close to the same time as taking the Prebiome Fibre supplement. Please make sure that you drink at least 1500ml of fluid per day of which 500 ml is water. - Blackmores Grapeseed Forte only (2 tablets/day) (Group B) for 16 weeks; This is to be taken by participants at 2 Tablets once per day with food. This is the same instructions as what stated on the bottle. - Prebiome Fibre (5g powder/twice per day) and Blackmores Grapeseed Forte (2 tablets/day) (Group C) for 16 weeks; We advise to mix Prebiome Fibre into food such as a smoothie, yoghurt, cereal, porridge or mashed fruit. Please also drink 250ml of water close to the same time as taking the Prebiome Fibre supplement. Please make sure that you drink at least 1500ml of fluid per day of which 500 ml is water. Grapeseed Forte is to be taken by participants at 2 Tablets once per day with food. This is the same instructions as what stated on the bottle. Participants will be contacted by the research team to check how they are progressing and they will request that participants are to take a photograph with their mobile phone or camera of the packaging of the supplement to see how much is left and send to the research team, so participants should not throw out any empty jars. This is how monitoring will take place.
Sponsors
University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female patients 60-70 (inclusive) years of age 2. The participant is able and willing to comply with the requirements of this trial protocol. 3. Sufficient English to answer study questionnaires 4. Willing to maintain existing diet and exercise patterns for the duration of the Trial 5. Voluntarily provided signed Informed Consent before any trial-related procedures are performed.
Exclusion criteria
1. Age of under 60 years or over 70 years 2. History of Inflammatory Bowel Disease, Irritable Bowel Syndrome or other bowel disease 3. History of Diabetes requiring Insulin for management 4. History of Cognitive Impairment and/or Dementia 5. Frailty 6. Already taking fibre or antioxidant supplements 7. Known allergies to berries, guar gum or other fibre supplements or grapes
Outcome results
None listed