None listed
Conditions
Brief summary
There is growing awareness that gut health is linked to virtually all aspects of human health, from digestive function to metabolic health, immunity, cognition, and mental wellbeing. At the same time, the prevalence of functional gut disorders is on the rise, thought to result from disturbances to the gut-brain axis. The Arepa formula has the potential to provide additive benefits along the gut-brain axis. The Neuroberry® blackcurrant cultivar used in the Arepa formula is unique to Aotearoa and is particularly rich in anthocyanins. Anthocyanins are thought to have a proliferative effect on ‘good’ gut bacteria, yet research in humans has been limited to date. Other plant-derived bio-actives in the Arepa formula are known to target stress, anxiety, cognition, and sleep – all of which can have beneficial effects on the gut microbiota and vice versa. A systems approach will be used in this research, providing insight into links between the gut microbiome, blood markers, neurocognitive responses, and diet. The researchers aim to determine whether daily consumption of the Arepa performance beverage has a prebiotic effect, improving the gut microbiota composition and its predicted function. This research also aims to tease apart the role of the gut microbiota in mediating the known neurocognitive benefits of Arepa.
Interventions
300mL of Arepa performance drink (blackcurrant-based, polyphenol-rich beverage available on the market containing approximately 300mg of anthocyanins, 200mg of L-theanine, and 150mg of Enzogenol) or a taste- and colour-matched 300mL placebo.
Participants will consume one beverage (intervention or placebo) once daily for 4 weeks, and after a 4-week wash-out period the participants will cross over and receive the other treatment. Participants will be instructed to consume the drink every day at
300mL of Arepa performance drink (blackcurrant-based, polyphenol-rich beverage available on the market containing approximately 300mg of anthocyanins, 200mg of L-theanine, and 150mg of Enzogenol) or a taste- and colour-matched 300mL placebo. Participants will consume one beverage (intervention or placebo) once daily for 4 weeks, and after a 4-week wash-out period the participants will cross over and receive the other treatment. Participants will be instructed to consume the drink every day at any time of day. Adherence will be monitored through a weekly self-report diary.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Outcome results
None listed