ACTRN12615000233527.

Study name	Efficacy and Safety of Arborvitae Health and Wellbeing Supplement on the Blood Glucose Levels in Pre‐Diabetic Participants.
Methods	"Phase IIa, randomised, double blind, placebo‐controlled, parallel design clinical trial." Target sample size: 116.
Participants	Inclusion criteria: men and women above 18 years of age who demonstrate impaired fasting glucose from 6.1 ‐ 6.9 mmol/L. Exclusion criteria: "Major illnesses that are deemed clinically significant; type II diabetes, anyone on anti‐obesity medications, dietary supplements. Alcohol abuse. Commencing lifestyle interventions (dietary changes and increasing exercise duration/intensity)."
Interventions	Treatment: 50 mL of active components (containing aloe vera 1.75 mg/mL, papain 2.4 mg/mL, Pinus pinaster 2.6 mg/mL, sodium chloride 3 mg/mL) given by oral solution 2x daily for 12 weeks. Control: 50 mL of placebo (containing sodium chloride 3.0 mg/mL) given by oral solution 2x daily for 12 weeks.
Outcomes	Primary outcomes: impaired fasting glucose: collected at baseline, 4, 8 and 12 weeks. Secondary outcomes: quality of life survey questionnaire (SF‐12v2): collected at baseline, 4, 8 and 12 weeks. The following blood samples were collected at baseline and at 12 weeks: impaired glucose tolerance, high‐sensitivity CRP, HbA1c, LDL cholesterol, HDL cholesterol and triglycerides. The study assessed safety by measuring liver function tests, urea and a full blood count: collected at baseline and 12 weeks.
Starting date	March 2015.
Contact information	Dr Samantha Coulson; samantha_coulson@medlab.co; Medlab Pty Ltd 66 McCauley St, Alexandria NSW 2015.
Notes	Country: Australia. Status of study: Recruiting. Sponsors and collaborators: Arborvitae Health and Wellbeing Pty Ltd, 10 Gordon St, Bankstown NSW 2200, Australia.