An investigative study on the safety and efficacy of French Maritime Pine Bark Extract, Papain and Aloe Vera in pre-diabetic participants
A Phase IIa Double-Blind Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Arborvitae Health and Wellbeing Supplement on the Blood Glucose Levels in Pre-Diabetic Participants.
Arborvitae Health and Wellbeing Pty Ltd
116 participants
Mar 26, 2015
Interventional
Conditions
Summary
The objective of study is to evaluate the safety and efficacy of the investigational product (Pinus Pinaster, Papain, Aloe vera) in pre-diabetic participants following oral adminstration of 50 mL twice daily.
Eligibility
Inclusion Criteria1
- Men and women who demonstrate IFG from 6.1-6.9 mmol/L
Exclusion Criteria1
- 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).
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Interventions
50 mL of active components or placebo is given by oral solution twice daily. Compliance will be checked by the count of bottles returned and participant's diary. Participants over the age of 18 who demonstrate IFG 6.1-6.9 mmol/L will be recruited for this study. Participants will attend a total of 5 visits. The total duration of the whole study is 12 weeks. Active components composition: Aloe vera 1.75 mg/mL Papain 2.4 mg/mL Pinus pinaster 2.6 mg/mL Sodium chloride 3 mg/mL
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ACTRN12615000233527