Investigating the effect of polyphenol rich sugarcane extract on the gut microbiome, mood and blood work.

Not Applicable

Active, not recruiting

• Conditions: Gastrointestinal health; Blood biomarkers; General wellbeing; Mood; Inflammation; Blood - Other blood disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12624000055505
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-23
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 98

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut bacteria diversity and composition [Gut bacteria diversity and composition will be assessed using faecal samples with 16S rRNA profiling and metagenomics techniques. Baseline, 3 months (end of phase 1, primary timepoint), 6 months (end of phase 2, primary timepoint)];Blood markers (finger prick blood assessment): HBA1c, C-reactive protein, TAGs, Omega-3 status. Blood markers will be assessed as a composite primary outcome. [Trajan’s MonitorYou” service (finger prick blood assessment). Baseline, 3 months (end of phase 1, primary timepoint), 6 months (end of phase 2, primary timepoint)];Quality of life assessed by the Assessment of Quality of Life (AQoL)-8D questionnaire.[Assessment of Quality of Life (AQoL)-8D questionnaire Baseline, 3 months (end of phase 1, primary timepoint), 6 months (end of phase 2, primary timepoint)]

Secondary Outcome Measures

Name	Time	Method
Change in Profile of Mood States-Adolescents (POMS-A)[Profile of Mood States-Adolescents (POMS-A) questionnaire. Baseline, 3 months (end of phase 1), 6 months (end of phase 2)]