This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.Description: This is a single dose open-label dose-escalation pilot study. Following a lead-in period for screening, recruitment, participants will be allocated to a zero-dose control group or different Indigo naturalis dose groups. The study involves a single 24 h intervention period over two study visits. Participants will be self-reported healthy adults (male or female, 18 – 65 years old), which represent the adult general population residing in Wellington, New Zealand. Following informed consent, the first five participants will take capsules containing 2 g of microcrystalline cellulose (zero-dose control group). The next group of five participants will take the lowest dose of Indigo naturalis. If data analysis of the lowest dose shows no detrimental effect on liver function, the next group of 5 individuals will take the next dose (0.5 g) of the herbal medicine and so on. If we find a consistent, significant change in blood AhR activity in plasma and/or PBMCs in this pilot study, we intent to subsequently conduct a follow up study involving administering Indigo naturalis in people with inflammatory conditions, such those associated with obesity, metabolic syndrome, diabetes or liver steatosis.
