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. |