Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001357145
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
3/10/2019
Date last updated
3/10/2019
Date data sharing statement initially provided
3/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the Nutrition-Care Gluco-Metabolism Formula on glucose levels in pre-diabetic adults: The Gluco-Metabolism Trial
Scientific title
Randomised double-blinded placebo-controlled trial of 12 weeks duration investigating the tolerability and effectiveness of the Nutrition-Care Gluco-Metabolism Formula on glucose control in pre-diabetic adults.
Secondary ID [1] 299131 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-diabetes 314198 0
Condition category
Condition code
Metabolic and Endocrine 312554 312554 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised double-blind placebo-controlled trial of 12 weeks duration investigating the effect and tolerability of the Nutrition-Care Gluco-Metabolism-Herbal Formula on glucose levels in pre-diabetic adults.
The intervention will comprise of 2x3 Gluco-Metabolism tablets (active group) or placebo (control group) daily for 12 weeks.
The active tablets contain a gymnema silvestre, cinnamon cassia, bitter melon, fenugreek, nigella sativa, portulaca oleracea, alpha-lipoic acid, chromium picolinate, and biotin. Daily dosage is 25g/ day.
Compliance will be assessed by returned tablet count at 4-weekly visits.
Intervention code [1] 315407 0
Treatment: Other
Comparator / control treatment
2x3 matching placebo tablets/ daily for 12 weeks containing microcrystalline cellulose powder
Control group
Placebo

Outcomes
Primary outcome [1] 321202 0
Fasting plasma glucose measured by fingerprick test and blood Glucose Meter
Timepoint [1] 321202 0
4,8,12 weeks of intervention compared to baseline
Primary outcome [2] 321203 0
Post-prandial plasma glucose measured by fingerprick test and blood Glucose Meter
Timepoint [2] 321203 0
12 weeks compared to baseline
Primary outcome [3] 321204 0
Ambulatory glucose profile (incl mean glucose levels) by continuous glucose monitoring using a permanently fitted Glucose Sensor (Abbott Freestyle Libre)
Timepoint [3] 321204 0
Twice continuously over a 2 week period: At enrolment (weeks 1+2) and at end of the study (weeks 11+12)
Secondary outcome [1] 374311 0
HbA1c by microspot blood test
Timepoint [1] 374311 0
0 and 12 weeks
Secondary outcome [2] 374312 0
Visceral fat by body impedance analysis (BIA)
Timepoint [2] 374312 0
0 and 12 weeks
Secondary outcome [3] 374313 0
Zonulin stool spot test
Timepoint [3] 374313 0
0 and 12 weeks
Secondary outcome [4] 374314 0
fasting insulin by blood test
Timepoint [4] 374314 0
0 and 12 weeks

Eligibility
Key inclusion criteria
1) Pre-diabetes: FPG: 5.5-7.0 mmol/l and/or PPG: 7.8-11.1 mmol/l
Assessment done with Accu-Chek Mobile Blood Glucose Meter (Roche) & disposable strips
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed with diabetes, on diabetic medication (e.g. insulin, metformin) or glucose control supplements
Diagnosed with chronic illness (cancer, non-fatty-liver), or pregnancy or breastfeeding
Taking vitamin C supplements or IVC, and not willing to stop for the length of the trial (as vitamin c can falsify plasma glucose readings)
If FPG or PPG are in the diabetic range during screening, the volunteer won’t be eligible to participate in the trial, and will be referred to a GP for follow-up.
Have had recent surgery, or planning on any surgery, or change of medication during the 3-4 month study
Intolerance or allergies to ingredients in Gluco-Metabolism formula

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)
Active and placebo tablets, matched in number, size and appearance, will be packaged offsite in visually identical numbered opaque containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization using computerized random number generator by independent researcher off-site
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed using SPSS (PASW version 18). Statistical significance will be set at p<0.05. Continuous variables will be analysed by student t-test and analysis-of-covariance (ANCOVA), and categorical variables will be analysed by Chi-square test. glucose curves will be analysed using standard deviation (SD, coefficient of variation (CV), and interquartile range (IQR) as described in Bergenstal 2013 J Diabetes Sci Tech 7 (2), 562-78.)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/10/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
31/08/2020
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 27682 0
3122 - Hawthorn
Recruitment postcode(s) [2] 27683 0
3123 - Hawthorn East

Funding & Sponsors
Funding source category [1] 303672 0
Commercial sector/Industry
Name [1] 303672 0
Nutrition Care
Country [1] 303672 0
Australia
Primary sponsor type
Individual
Name
AProf Dr Karin Ried
Address
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 303776 0
None
Name [1] 303776 0
Address [1] 303776 0
Country [1] 303776 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304194 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 304194 0
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 304194 0
Australia
Date submitted for ethics approval [1] 304194 0
04/06/2019
Approval date [1] 304194 0
01/07/2019
Ethics approval number [1] 304194 0
0055N_2019

Summary
Brief summary
Prevention and early diagnosis of diabetes is key to avoid diabetes-related complications. In 2018, 2 million Australians are estimated to have pre-diabetes and are at high-risk of developing type 2 diabetes.
The Nutrition-Care Gluco-Metabolism Formula contains a mixture of herbs and nutrients, which have been shown to be beneficial for balancing blood glucose levels in the blood. In this randomised double-blind placebo-controlled 12-week trial we aim to assess the tolerability and efficacy of the Gluco-Metabolism Formula for glucose control in pre-diabetics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96106 0
A/Prof Karin Ried
Address 96106 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 96106 0
Australia
Phone 96106 0
+61 3 9912 9545
Fax 96106 0
Email 96106 0
[email protected]
Contact person for public queries
Name 96107 0
A/Prof Karin Ried
Address 96107 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 96107 0
Australia
Phone 96107 0
+61 3 9912 9545
Fax 96107 0
Email 96107 0
[email protected]
Contact person for scientific queries
Name 96108 0
A/Prof Karin Ried
Address 96108 0
National Institute of Integrative Medicine
21 Burwood Rd
Hawthorn VIC 3122
Country 96108 0
Australia
Phone 96108 0
+61 3 9912 9545
Fax 96108 0
Email 96108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Randomised controlled trial. Data will be summarized for publication. No individual data will be divulged in publications.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4357Ethical approval    378262-(Uploaded-27-08-2019-18-39-22)-Study-related document.pdf



Results publications and other study-related documents

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