Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000928011
Ethics application status
Approved
Date submitted
26/10/2010
Date registered
2/11/2010
Date last updated
2/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A proprietary blend of Phellodendron and Crape Myrtle improves glucose tolerance in response to an oral dextrose load in exercise-trained non-diabetic men
Scientific title
A proprietary blend of Phellodendron and Crape Myrtle improves glucose tolerance in response to an oral dextrose load in exercise-trained non-diabetic men
Secondary ID [1] 252884 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
glucose tolerance 258416 0
Condition category
Condition code
Metabolic and Endocrine 258583 258583 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) Oral capsule was the mode of administration

a)proprietary blend of 750mg of Phellodendron [bark] and Crape Myrtle [Lagerstroemia Speciosia] stem [Anabolic Pump (TM); USPlabs, LLC, Dallas, TX]

b)single dose only

7 day washout period
Intervention code [1] 257411 0
Treatment: Drugs
Comparator / control treatment
single oral dose of microcrystalline cellulose
Control group
Placebo

Outcomes
Primary outcome [1] 259426 0
serum glucose
Timepoint [1] 259426 0
The OGTT was administered 15 minutes after the capsule.

pre - capsule

15min, 30min, 45min, 60min, and 75min post - oral glucose tolerance test
Secondary outcome [1] 265975 0
serum insulin
Timepoint [1] 265975 0
The OGTT was administered 15 minutes after the capsule.


pre - capsule

15min, 30min, 45min, 60min, and 75min post - oral glucose tolerance test

Eligibility
Key inclusion criteria
Ten healthy, exercise-trained men.
Minimum age
18 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects were not smokers, and did not have diagnosed cardiovascular or metabolic disease (including diabetes). Subjects were not using dietary supplements believed to influence blood glucose disposal.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
a randomized, double-blind, cross-over design

Allocation concealled by numbered containers and central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 2975 0
United States of America
State/province [1] 2975 0
Tennessee

Funding & Sponsors
Funding source category [1] 257852 0
Commercial sector/Industry
Name [1] 257852 0
USPlabs, LLC
Country [1] 257852 0
United States of America
Primary sponsor type
University
Name
The University of Memphis
Address
The University of Memphis

161F Elma Neal Roane Fieldhouse

Memphis, TN 38152
Country
United States of America
Secondary sponsor category [1] 257161 0
Individual
Name [1] 257161 0
Dr. Richard J Bloomer
Address [1] 257161 0
The University of Memphis

161F Elma Neal Roane Fieldhouse

Memphis, TN 38152
Country [1] 257161 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259887 0
University of Memphis Institutional Review Board
Ethics committee address [1] 259887 0
Ethics committee country [1] 259887 0
United States of America
Date submitted for ethics approval [1] 259887 0
Approval date [1] 259887 0
Ethics approval number [1] 259887 0

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

Contacts
Principal investigator
Name 31783 0
Address 31783 0
Country 31783 0
Phone 31783 0
Fax 31783 0
Email 31783 0
Contact person for public queries
Name 15030 0
Robert Canale
Address 15030 0
The University of Memphis

161C Elma Neal Roane Fieldhouse

Memphis, TN 38152
Country 15030 0
United States of America
Phone 15030 0
+1 901-678-1547
Fax 15030 0
Email 15030 0
[email protected]
Contact person for scientific queries
Name 5958 0
Dr. Richard Bloomer
Address 5958 0
Richard J. Bloomer, PhD, CSCS

The University of Memphis

161F Elma Neal Roane Fieldhouse

Memphis, TN 38152
Country 5958 0
United States of America
Phone 5958 0
+1 901-678-4341
Fax 5958 0
Email 5958 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.