Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001571167
Ethics application status
Approved
Date submitted
31/10/2019
Date registered
14/11/2019
Date last updated
14/11/2019
Date data sharing statement initially provided
14/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A placebo-controlled, single-blind, crossover study to assess the effects of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants
Scientific title
A placebo-controlled, single-blind, crossover study to assess the effects of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants
Secondary ID [1] 299685 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysglycaemia 315037 0
Glycaemic control 315038 0
Diabetes 315120 0
Condition category
Condition code
Diet and Nutrition 313367 313367 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 313368 313368 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study was an acute, placebo-controlled, single-blind, crossover study consisting of 50mg and 400mg of New Zealand pine bark extract (Enzogenol®) on glycaemic responses in healthy participants.
Briefly, at each visit, participants arrived at the facility after at least a 10 h overnight fast (water was allowed). The first study visit was a control visit whereby participants consumed a single placebo capsule containing only microcrystalline cellulose. The second and third visits were treatment visits where patients consumed a single opaque capsule of 50 and 400mg of Enzogenol®, respectively. Each capsule was identical in appearance (size, form and colour). As this is a single-blind study, the participants did not know what dosage they were given at each visit. An OGTT was commenced at all three visits twenty minutes after consuming the capsule. Participants were given a bottle of 300 mL of glucose drink Carbotest (Fronine, Thermo Fisher Scientific, Australia) containing 75 g of carbohydrates to consume within five minutes.
Capillary blood samples were obtained via finger prick with a single use disposable lancet (Accu-Chek Safe T-Pro Plus) twenty minutes before the commencement of oral glucose tolerance test (OGTT), and again at 0, 15, 30, 45, 60, 90, and 120 min after consuming the glucose drink. Blood glucose levels were immediately measured using a glucose meter (MediSense, Optium, Abbott, 2.7-4.0% CV). There was at least a washout period of 48 hour between each visit.
Participants were instructed to maintain a consistent diet without any dietary alterations throughout the duration of the study. They were also asked to abstain from alcohol and beverages such as teas, coffees and energy drinks (both caffeinated and decaffeinated), all health supplements that might influence glucose metabolism, and strenuous activity during the 24h period before each visit. The participants were checked for compliance by the researcher with a checklist at each visit prior to commencing the OGTT.
Intervention code [1] 315951 0
Prevention
Intervention code [2] 315952 0
Treatment: Other
Comparator / control treatment
Control treatment was a single placebo capsule containing only microcrystalline cellulose. The placebo capsule was of identical appearance (size, form and colour) to the capsules containing either 50 or 400mg of Enzogenol®.
Control group
Placebo

Outcomes
Primary outcome [1] 321849 0
Capillary blood samples were obtained via finger prick with a single use disposable lancet (Accu-Chek Safe T-Pro Plus) twenty minutes before the commencement of OGTT, and again at 0, 15, 30, 45, 60, 90, and 120 min during the OGTT. Blood glucose levels were immediately measured using a glucose meter (MediSense, Optium, Abbott, 2.7-4.0% CV). Incremental area under the curve of postprandial glucose was then calculated.
Timepoint [1] 321849 0
-20, 0, 15, 30, 45, 60, 90 and 120 min during the OGTT.
Secondary outcome [1] 376470 0
Nil
Timepoint [1] 376470 0
Nil

Eligibility
Key inclusion criteria
• 18-40 years of age
• BMI 18.5-25.0 kg/ m2
• HbA1c < 40 mmol/ mol
• Fasting glucose < 5.5 mmol/ L
• Not taking any medications that include blood glucose/ sugar lowering prescriptions
• Not pregnant or breastfeeding
• Not allergic to pine bark extract
• Non-smoker
• Generally healthy and not suffering from chronic diseases or diabetes
• Able to communicate well in English
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants were excluded from the study if they had any form of cardiovascular, metabolic diseases, digestive ailments, if they smoked, were pregnant or lactating, and if they had any known allergies to pine bark extract or were taking medications or health supplements that would influence glycaemia.

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


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis used will be one-way repeated measures ANOVA with Bonferrroni Post Hoc analyses

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/03/2018
Date of last participant enrolment
Anticipated
Actual
30/11/2018
Date of last data collection
Anticipated
Actual
14/12/2018
Sample size
Target
20
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 21978 0
New Zealand
State/province [1] 21978 0
Auckland

Funding & Sponsors
Funding source category [1] 304163 0
Commercial sector/Industry
Name [1] 304163 0
ENZO Nutraceutical Limited
Country [1] 304163 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
School of Health Sciences, Palmerston North 4442, New Zealand
Country
New Zealand
Secondary sponsor category [1] 304390 0
None
Name [1] 304390 0
Nil
Address [1] 304390 0
Nil
Country [1] 304390 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304639 0
Health and Disability Ethnics Committee (HDEC)
Ethics committee address [1] 304639 0
Ethics committee country [1] 304639 0
New Zealand
Date submitted for ethics approval [1] 304639 0
20/11/2017
Approval date [1] 304639 0
23/03/2018
Ethics approval number [1] 304639 0
SOA 17/73

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97682 0
Ms Wen Xin Janice Lim
Address 97682 0
School of Health Sciences, Massey University, Auckland 0632, New Zealand
Country 97682 0
New Zealand
Phone 97682 0
+64 0210 890 3957
Fax 97682 0
Email 97682 0
[email protected]
Contact person for public queries
Name 97683 0
Rachel Page
Address 97683 0
School of Health Sciences, Massey University, Wellington 6021, New Zealand
Country 97683 0
New Zealand
Phone 97683 0
+64 4 801 5799
Fax 97683 0
Email 97683 0
[email protected]
Contact person for scientific queries
Name 97684 0
Rachel Page
Address 97684 0
School of Health Sciences, Massey University, Wellington 6021, New Zealand
Country 97684 0
New Zealand
Phone 97684 0
+64 4 801 5799
Fax 97684 0
Email 97684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator. The Principal Investigator can be contacted at [email protected]


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
SourceTitleYear of PublicationDOI
EmbaseAn acute, placebo-controlled, single-blind, crossover, dose-response, exploratory study to assess the effects of New Zealand pine bark extract (Enzogenol) on glycaemic responses in healthy participants.2020https://dx.doi.org/10.3390/nu12020497
N.B. These documents automatically identified may not have been verified by the study sponsor.