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: The objective of this study was to evaluate effects of a nut-based higher-protein snack/meal replacment on glycaemic control in a group of Asian Chinese adults with overweight and pre-diabetes; assessing both post-prandial and longer term fasting outcomes.
No individual participant data for this trial will be made available. This is in accordance to National Health and Disability Ethics Committees application that all data generated will only be used for this study only.
Principal investigator organisation
University of Auckland
Collaborating researchers and affiliations
Principal Investigator:
Professor Sally Poppitt, Director, Human Nutrition Unit, University of Auckland, Auckland
Investigators:
- Dr Meika Foster, Edible Research, NZ;
- Professor Jeremy Krebs, University of Otago, Wellington Hospital
Data description
Outcomes of the Study and associated data
Primary outcome:
- Differences in fasting plasma glucose between groups at -1, 2, 4, 8 and 12 weeks
- Differences in postprandial plasma glucose & insulin following a 2h oral glucose tolerance test between group at weeks -1 and 12
Associated data: Fasting plasma glucose, plasma glucose & insulin following 2h OGTT
Secondary outcomes:
- Differences in fasting insulin between groups at weeks -1, 2, 4, 8 and 12
- Differences in HbA1c between groups at weeks -1 and 12
- Differences in body weight between groups at weeks -1, 2, 4, 8 and 12
- Differences in body composition (fat mass and fat free mass) between groups assessed by DeXA at weeks -1 and 12
- Cross sectional analysis of ectopic fat distribution (liver and pancreas) using Magnetic Resonance Imaging (MRI) and MRS at -1 weeks
- Homeostatic model of beta cell function and insulin resistance (HOMA-IR) at weeks -1 and 12
- Full lipid profile (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) at weeks -1 and 12
- Fasting and postprandial gut peptides/appetite hormone profile, including glucagon-like peptide (GLP-1), peptide YY (PYY) and cholecystokinin (CKK) at weeks -1 and 12
- Differences in body mass index between groups at weeks -1, 2, 4, 8 and 12
- Differences in the microbiome community (bacterial count) assessed through collection of a spot fecal sample at weeks -1 and 12
- Differences in markers of inflammation - C reactive protein (hsCRP), IL-6, DKK-1, BDNF, S100beta at weeks -1 and 12
Associated data: insulin, HbA1c, body weight, fat mass and fat free mass, ectopic fat distribution (liver and pancreas), HOMA-IR, compositve macronutritient intake, lipid profile (total cholesterol, LDL, HDL, triglycerides), fasting and postprandial gut peptides/apptetite hormone profile (GLP-1, PYY, CKK), BMI, microbiome community, inflammatory markers (hsCRP, IL-6, DKK-1, BDNF, S100beta)