None listed
Conditions
Brief summary
Kawakawa is a versatile herb, endemic to New Zealand, where it is widely used for food, medicinal, and traditional ceremonial purposes by Maori. Kawakawa leaves and fruits are reported to possess medicinal properties and are utilised for a wide range of health conditions not only limited to skin diseases but for the treatment of genitourinary, gastrointestinal as well as respiratory diseases. A previous study by Butts et al (2019) described that there is a significant number of chemical constituents present in kawakawa leaves with potential pharmacological properties. Therefore, as a candidate for potential functional food applications, examining the bioavailability of kawakawa metabolites for human consumption is required. In-vitro or mechanistic studies carried out with kawakawa leaves and fruits have discovered that they are safe for human consumption and have potential health benefits. With the advent of this, there exists a scientific need to explore the mechanisms of human metabolism and bioavailability upon the ingestion of kawakawa tea. Therefore, the aim of this study is to evaluate the bioavailability of kawakawa metabolites from commercially available kawakawa tea leaves and its effects on other metabolic and biochemical parameters in healthy adults.
Interventions
This study will examine the response after an acute (single) ingestion of either water or different doses of Kawakawa tea (1g or 4g per 250ml of hot water). The postprandial state lasts for approximately 4-5 h post-meal period, the study is to be carried out for 6h. Participants under the supervision of clinical coordinator will complete a screening assessment and if eligible for entry into the trial will be required in fasted condition to consume either a kawakawa tea infusion (1g or 4g per 250
This study will examine the response after an acute (single) ingestion of either water or different doses of Kawakawa tea (1g or 4g per 250ml of hot water). The postprandial state lasts for approximately 4-5 h post-meal period, the study is to be carried out for 6h. Participants under the supervision of clinical coordinator will complete a screening assessment and if eligible for entry into the trial will be required in fasted condition to consume either a kawakawa tea infusion (1g or 4g per 250ml of hot water) or only hot water within 15 minutes. Following the tea ingestion, a standard breakfast will be provided at 60 minutes. Blood will be sampled at 0, 30, 45, 60, 90, 120, 180, 240, 300 mins, and 24 h from an arm vein (total 220ml blood) by a certified phlebotomist or registered nurse. Urine samples will be collected for 24 h with a time frame of 0, 0-2, 2-4, 4-5, 5-24 h after the consumption of tea. A washout period of 1 week is required between each intervention, therefore the participants will be informed to come for their second and third intervention visits after a washout of 1 week.
Sponsors
Liggins Institute, The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Males participants will be included to participate if • BMI- 18-30 kg/m2 • Non-smokers • Self-reported not consuming dietary supplements • No medical conditions
Exclusion criteria
Participants will be excluded from participation if they: • Female subjects • Are taking dietary supplements or herbal remedies which may affect the study outcome • Are allergic to pepper, nutmeg or similar spices • Are diagnosed with gastrointestinal disease (i.e. celiac, Crohn’s, colitis, etc.) or pre-existing metabolic disease • Are currently taking medications expected to interfere with normal digestive or metabolic processes including proton pump inhibitors, laxatives, etc. • Have used antibiotics within the previous one month or were on long-term antibiotic therapy.
Outcome results
None listed