None listed
Conditions
Brief summary
PRSE’s naturally occur in plant derived foods and beverages and holds great potential for enhancing human health. However, further research is required to understand the broad-spectrum of effects of PRSE’s by assessing its potential short and long-term benefits to general well-being. This study is a 6 month double-blinded randomised controlled cross over trial. Participants will receive either the control sample (placebo) or the PRSE sample for a duration of 3 months, followed by the reversal of conditions for the subsequent 3 months. The nutritional intervention is to be completed in the participants own setting (i.e. home/work). This study aims to investigate the prebiotic effects of PRSE, as well as the effects on inflammation and key blood biomarkers, including HbA1c, C-reactive protein, and triglycerides/omega-3 status. The study will also explore the influence of PRSE on general mood and well-being.
Interventions
The nutritional intervention is a Polyphenol Rich Sugarcane Extract PRSE. Participants are expected to consume two capsules a day, one in the evening and one at night at approximately the same time each day (± 60 mins). PRSE’s can be consumed with or without food and on an empty stomach. Each capsule contains 250 mg of PRSE.
Participants will receive either the control sample (placebo) or the PRSE sample for a duration of 3 months, followed by the reversal of conditions for the subsequent 3 mon
The nutritional intervention is a Polyphenol Rich Sugarcane Extract PRSE. Participants are expected to consume two capsules a day, one in the evening and one at night at approximately the same time each day (± 60 mins). PRSE’s can be consumed with or without food and on an empty stomach. Each capsule contains 250 mg of PRSE. Participants will receive either the control sample (placebo) or the PRSE sample for a duration of 3 months, followed by the reversal of conditions for the subsequent 3 months. The samples will be sent to participants via mail at the commencement of each phase. The nutritional intervention is to be completed (consumed) in the participants own setting (i.e. home/work). There is no washout period between phases. Daily adherence will be tracked through a short emailed online questionnaire, where participants record their daily intake. Additionally, at the end of each month, participants will report the number of capsules remaining.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
- Aged 18-55 years of age - Currently live in Australia - Able to communicate fluently in English - No history of / do not currently suffer from heart disease, high blood pressure, diabetes (Type 1 or Type 2) or any other chronic disease (in the judgement of the investigator) or medical conditions that may affect participant adherence to the trial investigation. - Are not taking any medication (including antibiotics or frequent use of NSAIDs), herbal extracts, vitamin supplements, illicit substances, and are committed to abstaining from taking any non-critical medications from 2 weeks prior of commencement and throughout the study. - Committed to maintaining current diet and exercise regime from one week prior to study commencement and for the duration of the study. - Are not currently participating in any other trials involving investigational or marketed products within 30 days prior to study commencement. -. Are able to provide self-assessed anthropometric measurements (i.e. height and weight and has access to scales). - Willingness to comply with all requirements and procedures of the study.
Exclusion criteria
- Pregnant, lactating or intending to become pregnant - A smoker and / or alcoholic drinker (averages 2 or more standard drinks a day).
Outcome results
None listed