Polyphenol-rich drink for gut and brain health

Not Applicable

• Conditions: eurocognitive disturbances; Gastrointestinal dysbiosis; Neurocognitive disturbances; Diet and Nutrition - Other diet and nutrition disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12622000850774
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-16
• Last Update Posted: 20 June 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

•Females aged between 18-45 years.
•BMI between 18-30 kg/m2.
•Not pregnant, nor intending to become pregnant during the trial.
•Has access to internet and a computer, smart phone, or tablet.
•Agree not to enroll in another interventional clinical research trial 4 weeks prior to and for the duration of the study period
•Understands, and is willing and able to comply with all study procedures
•Willing and able to provide written informed consent

Exclusion Criteria

•Treated for anxiety, depression, or psychiatric disorders within the past two years.
•Diagnosed with gastrointestinal disorders (Coeliac disease, ulcerative colitis, Crohn’s disease), or had past major gastrointestinal surgery likely to interfere with study outcomes (e.g., hemi colectomy, ileostomy, colostomy).
•History of neurological disorders (e.g., Epilepsy, Parkinson’s Disease, stroke, serious head trauma), cognitive impairment, cardiovascular diseases or diabetes requiring medication.
•Medication use expected to interfere with normal digestive processes, including proton pump inhibitors, laxatives.
•Antibiotic use in the four weeks prior to the intervention.
•Prebiotic or probiotic supplement use and are not willing to cease intake for four weeks prior to (and duration of) the intervention.
•Herbal extract supplement use expected to interfere with cognition or mood and are not willing to cease use for four weeks prior to (and duration of) the intervention.
•Self-reported alcohol intake exceeding a moderate intake (>15 standard drinks/week).
•Regular use of recreational/illicit drugs
•Sensitivity to the investigational product, or any of the active/inactive ingredients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in stress reactivity to a multi-tasking cognitive stressor (purple multi-tasking framework), measured by Bond-Lader visual analogue mood scales and the State-Trait Anxiety Inventory (State subscale). This is reported as a composite measure. [Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement. ]