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: Kawakawa (Piper excelsum) is endemic to Aotearoa, New Zealand, and, as a taonga, is of great cultural importance to Maori. Kawakawa is used extensively in rongoa Maori (traditional Maori healing). The pharmacology of kawakawa is complex, with studies reporting kawakawa to contain several biologically active compounds that influence inflammation and related pathways. For example, myristicin inhibits the production of several pro-inflammatory cytokines, such as NO, IL-6 and IL-10, in mouse macrophages and THP-1 monocytes. Elemicin, another aromatic compound in kawakawa, is known to play a role in inhibiting IL-6. We hypothesize that the consumption of kawakawa would impact the inflammatory pathways by enhancing anti-inflammatory effects. However, several confounding variables, such as individualized differences in kawakawa tea preparation and doses and variability in the bioavailability of the active kawakawa constituents, could also alter the anti-inflammatory effects. Therefore, controlled human kawakawa trials are necessary to evaluate the effects of different doses of kawakawa consumption on inflammatory markers. To test our hypothesis, this study aims to quantify the effects of different kawakawa doses on inflammatory markers in healthy human volunteers.
Publisher
University of AucklandTemporal coverage: start
2022-01-01HVN Project / Programme Name
HVN1917Data access requirements
All of the Individual participant data (including data dictionaries) collected during the trial will be available after de-identification, along with the study protocol. Data will be available beginning 3 months following the first publication of study results and ending 36 months following publication. Data will be available to investigators who provide a methodologically sound proposal approved by the Study Steering Committee, for use to achieve the aims in the approved proposal. Proposals should be directed to the principal investigator (f.ramzan@auckland.ac.nz). To gain access, requests will need to sign a data access agreement.Principal investigator organisation
University of AucklandCollaborating researchers and affiliations
Principal Investigator:
Dr Farha Ramzan, Liggins Institute, University of Auckland, Auckland
Co-Principal Investigator:
Dr Chris Pook, University of Auckland, Auckland
Co-Investigators:
Professor Richard Mithen, Liggins Insititute, University of Auckland, Auckland
Dr Meika Foster, Edible Research, University of Auckland, Auckland and Wakatū Incorporation
Dr Jennifer Miles-Chan, Human Nutrition Unit, University of Auckland, Auckland
Dr Ali Rashidinejad (Riddet Institute),
Professor Joanne Hort (Massey University)Data description
Outcomes of the Study and associated data
Primary outcomes
- Blood levels of Interleukin (IL)-6
Associated data: IL-6
Secondary outcomes
- postprandial glucose and insulin response to 75g oral glucose tolerance test (OGTT)
- Fasting plasma triglycerides
- Fasting plasma insulin
- Insulin resistance, defined by the homeostasis model of assessment (HOMA-IR)
- Whole-body insulin sensitivity index (ISI) using the Matsuda index
- Plasma metabolic profile
- Urine metabolic profile
- Biomarkers of inflammation
- Metabolic and inflammatory-related mononuclear cell (PBMCs) gene expression
Associated data: postprandial glucose & insulin, plasma triglyceride, plasma insulin, HOMA-IR, ISI, plasma metabolites, urine metabolites, CRP, IL-12, IL-1b, IL-8, IL-10, TNF-aPrincipal investigator contact email
f.ramzan@auckland.ac.nz
