None listed
Conditions
Brief summary
The REAL study is a pilot randomised, placebo-controlled clinical trial investigating the effects of green rooibos tea extract supplementation (dose = 500mg of rooibos extract) on anxiety levels in mildly to moderately anxious adults. The study incorporates a one week baseline period, 8-week intervention period and 2-week follow up.
Interventions
Designed as a pilot double blind, randomised, placebo controlled, parallel trial, enrolled participants will be randomised into either the active or control group. The study incorporates a one week baseline period, 8-week intervention period and 2-week follow up. After baseline measurements, participants in the active group will receive "active" capsules containing 250mg of green rooibos extract (19.25mg of Aspalathin). Participants will consume one capsule/day for the first week of the interven
Designed as a pilot double blind, randomised, placebo controlled, parallel trial, enrolled participants will be randomised into either the active or control group. The study incorporates a one week baseline period, 8-week intervention period and 2-week follow up. After baseline measurements, participants in the active group will receive "active" capsules containing 250mg of green rooibos extract (19.25mg of Aspalathin). Participants will consume one capsule/day for the first week of the intervention period and increase this to two capsules per day for the remaining 7 weeks of the intervention period (trial intervention period = 8 weeks). Participants will be asked to return any unused capsules at each clinic visit. Unused capsules will be counted to determine compliance.
Sponsors
University of Canberra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Healthy participants with mild to moderate anxiety levels that score between 11 and 25 (inclusive) on the Beck Anxiety Inventory (screening measure). Participants will be in general good health, willing to comply with all study procedures, and avoid consumption of rooibos tea/extract in any other form throughout the trial (other than through the intervention).
Exclusion criteria
Participants will be excluded from the study if they: • have a BMI >= 35kg/m2, • have blood pressure >= 160/95 mmHg, • take or have taken within 8 weeks prior to enrollment any anti-anxiety or antidepressant medication or supplement (e.g. St. John's wort, valerian, ashwagandha, CBD oil, etc.), • take sleep, gastrointestinal, cardiovascular or other medication or supplement deemed to interfere with measured parameters, • have taken antibiotics within 8 weeks prior to enrollment, • have taken probiotics/prebiotics/postbiotics within 2 weeks prior to enrollment, • are receiving or have received any kind of formal psychological treatment for anxiety within 8 weeks prior to enrollment, • have a known allergy or hypersensitivity to any of the components of the study product, • are pregnant or lactating, • are currently participating in other intervention studies, • have any chronic diseases, including but not limited to CVD, diabetes (Type I and Type II), cancer, kidney disease, gastrointestinal disease, clinically diagnosed mental illness or are severely immunocompromised, • have planned surgical procedures during the course of the study; • have any physical injuries preventing the participation in exercise testing.
Outcome results
None listed