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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000233527

Enrollment

116

Registered

2015-03-13

Start date

2015-03-26

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Men and women who demonstrate IFG 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).

Outcome results