Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000233527
Ethics application status
Approved
Date submitted
3/03/2015
Date registered
13/03/2015
Date last updated
9/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigative study on the safety and efficacy of French Maritime Pine Bark Extract, Papain and Aloe Vera in pre-diabetic participants
Scientific title
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.
Secondary ID [1] 286291 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 294374 0
Condition category
Condition code
Metabolic and Endocrine 294689 294689 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 291321 0
Treatment: Other
Intervention code [2] 291385 0
Treatment: Drugs
Comparator / control treatment
Two treatment arms, participants will be randomised onto an active or a placebo solution given orally.

Placebo components composition:
Sodium Chloride 3.0 mg/mL
Control group
Placebo

Outcomes
Primary outcome [1] 294453 0
Impared Fasting Glucose.
Timepoint [1] 294453 0
Bloods are taken for IFG at Screening, Week 4, Week 8, Week 12.
Secondary outcome [1] 313353 0
Impaired glucose tolerance
Timepoint [1] 313353 0
Blood samples are taken at Baseline and Week 12
Secondary outcome [2] 313354 0
hs-CRP
Timepoint [2] 313354 0
Blood samples are taken at Baseline and Week 12
Secondary outcome [3] 313355 0
HbA1c level
Timepoint [3] 313355 0
Blood samples are taken at Baseline and Week 12
Secondary outcome [4] 313356 0
Safety bloods (ELFTs, Urea, FBC)
Timepoint [4] 313356 0
Blood samples are taken at Baseline and Week 12
Secondary outcome [5] 313357 0
Lipid profile (HDL, LDL, TGs)
Timepoint [5] 313357 0
Blood samples are taken at Baseline and Week 12
Secondary outcome [6] 313358 0
Quality of Life (SF-12v2 Questionnaire)
Timepoint [6] 313358 0
Questionnaires are filled in at Baseline, Week 4, Week 8 and Week 12

Eligibility
Key inclusion criteria
Men and women who demonstrate IFG from 6.1-6.9 mmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment by central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/03/2015
Actual
26/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 290857 0
Commercial sector/Industry
Name [1] 290857 0
Arborvitae Health and Wellbeing Pty Ltd
Country [1] 290857 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Arborvitae Health and Wellbeing Pty Ltd
Address
10 Gordon St, Bankstown NSW 2200
Country
Australia
Secondary sponsor category [1] 289549 0
None
Name [1] 289549 0
Address [1] 289549 0
Country [1] 289549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292473 0
National Institute Of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 292473 0
11-23 Burwood Rd, Hawthorn
Melbourne VIC 3122
Ethics committee country [1] 292473 0
Australia
Date submitted for ethics approval [1] 292473 0
Approval date [1] 292473 0
16/02/2015
Ethics approval number [1] 292473 0
00252

Summary
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.
Trial website
http://trialfacts.com/current-trials/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55450 0
Prof Luis Vitetta
Address 55450 0
Medlab Pty Ltd 66 McCauley st,
Alexandria NSW 2015
Country 55450 0
Australia
Phone 55450 0
+61 (02) 8094 1939
Fax 55450 0
+61 (02) 9699 3347
Email 55450 0
[email protected]
Contact person for public queries
Name 55451 0
Dr Samantha Coulson
Address 55451 0
Medlab Pty Ltd 66 McCauley St,
Alexandria NSW 2015
Country 55451 0
Australia
Phone 55451 0
+61 (02) 8188 0311
Fax 55451 0
Email 55451 0
[email protected]
Contact person for scientific queries
Name 55452 0
Dr Samantha Coulson
Address 55452 0
Medlab Pty Ltd 66 McCauley St,
Alexandria NSW 2015
Country 55452 0
Australia
Phone 55452 0
+61 (02) 8188 0311
Fax 55452 0
Email 55452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.