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.
Publisher
University of AucklandTemporal coverage: start
2021-01-01HVN Project / Programme Name
HVN NZ-INDESData access requirements
All of the individual participant data collected during the trial, after de-identification, will be made available upon publication.Principal investigator organisation
Malaghan Institute of Medical ResearchCollaborating researchers and affiliations
Principal Investigators:
Dr Olivier Gasser, Translational Immunology Group Leader, Malaghan Institute of Medical Research
Wellington, New Zealand
Dr Jeffry Tang, Malaghan Institute of Medical Research, Wellington, New Zealand
Co-Investigators:
Dr Alissa Cait (Malaghan Institute of Medical Research)
Dr David O’ Sullivan (Malaghan Institute of Medical Research)
Collaborator:
A/Prof Patries Herst (University of Otago Wellington Campus)Data description
Outcomes of the study and associated data
Primary Outcome
- Changes in blood AhR activity, as determined by measuring the level of AhR activity in plasma sampled across five time points (0 h [baseline, fasted], 1, 3, 6 and 24 h) over the course of the 24h intervention
Associated data: Blood AhR luciferase reporter assay data
Secondary Outcomes
- Changes in the expression level of the proto typical downstream AhR-regulated protein target, CYP1A1 in peripheral blood mononuclear cells, isolated from whole blood
- Changes in plasma levels of the AhR-regulated cytokines, interleukins 22 and 10 (IL-22and IL-10)
- Determine the potential association between oral dose of Indigo naturalis with changes in liver function, sampled at various time points (1, 3, 6 and 24 h) and compared to the those found at baseline (0 h)
Associated data: Peripheral blood mononuclear cells (PCMBs) flow cytometry data, Blood Cytokine ELISAs data, Liver function tests (alanine aminotransferase, alkaline phosphatase, bilirubin)
Other associated data: Individual information, anthropometric measurements, 3-day food diary, 4-day food diaryPrincipal investigator contact email
ogasser@malaghan.org.nz
