Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000361303
Ethics application status
Approved
Date submitted
6/03/2017
Date registered
8/03/2017
Date last updated
17/07/2019
Date data sharing statement initially provided
17/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') on blood glucose levels in prediabetes and type 2 diabetes- A pilot study
Scientific title
The effect of nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') on blood glucose levels in prediabetes and type 2 diabetes- A pilot study
Secondary ID [1] 291373 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes mellitus 302362 0
Condition category
Condition code
Metabolic and Endocrine 301948 301948 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the potential of commercially available nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas.
This study has one intervention:
Intervention 1 (week zero to week 12): To use nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor in patients with type 2 diabetes mellitus.

Thompson’s Super Bioflavonoid Complex 'Registered Trademark':
Active Compounds: Citrus bioflavonoid extract, ascorbic acid, rutin, sodium ascorbate.
Composition: Citrus Bioflavonoid Extract-500 mg; Ascorbic Acid- 390 mg; Rutin- 100 mg; Sodium ascorbate- 125.3 mg.
Number of Tablets in each pack: 120
Mode of Administration: Two tablets per day before/with meal (NOT AFTER MEAL)

Strategies used to monitor adherence to the intervention: Participants will be asked to complete a logbook to record the day and time they take the tablets.
Intervention code [1] 297399 0
Treatment: Drugs
Comparator / control treatment
The control group will use placebo. The placebo tablets will contain the same excipients as the active tablets, but the active herbal extract would be replaced by excipients.
The excipients in the Thompson's Super Bioflavonoid Complex are microcrystalline cellulose (BP), calcium hydrogen phosphate dehydrate (USP), silica – colloidal anhydrous (BP), crospovidone (BP) and magnesium stearate (BP).

Placebo will be sourced from the Integria Healthcare Pty Limited (the same company who produce Thompson's supplement). All their products are manufactured under pharmaceutical GMP by facilities licensed by the TGA (as required by law).
Control group
Placebo

Outcomes
Primary outcome [1] 301369 0
Change in blood glucose levels: This can be measured using glucometers and HbA1c measuring devices.
Timepoint [1] 301369 0
after 12 weeks of the use of the supplements
Secondary outcome [1] 332450 0
Change in levels of oxidative stress: Oxidative stress can be chemically measured using 8-Hydroxy deoxyguanosine ELISA kit and Human resistin ELISA kit.
Timepoint [1] 332450 0
After 12 weeks of the supplement intake
Secondary outcome [2] 332486 0
Changes in the levels of serum lipids: Serum lipids can be measured chemically using ELISA kits.
Timepoint [2] 332486 0
After 12 weeks of taking each supplement.
Secondary outcome [3] 332487 0
Change in the levels of Dipeptidyl Peptidase 4 (DPP-4) enzyme activity: Using DPP-4 ELISA kit.
Timepoint [3] 332487 0
After 12 weeks of taking each supplement.

Eligibility
Key inclusion criteria
For all participants
1. Have been clinically diagnosed with type 2 diabetes.
2. Aged between (25 and 75) years.
3. Lean, overweight or obese (BMI 19 to 35 kg/m2).
4. Have normal or controlled blood pressure.
5. Normotensive (seated brachial blood pressure less than 140/90 mmHg).
6. Have given signed informed consent to participate in the study.
7. Clinically diagnosed T2D on diet and lifestyle intervention or metformin only treatment (e.g. fasting plasma glucose equal or more than 7.0mM, HbA1c).
8. Willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks.
9. Negative pregnancy test for the woman during their reproductive life.
Minimum age
25 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For all participants
1. Age less than 25 yrs or more than 75 yrs
2. Morbidly obese with a BMI equal or more than 35 kg/m2
3. Not on diet and lifestyle or metformin only treatment for their diabetes (e.g. insulin injections, sulphonylureas, GLP-1 receptor agonists).
4. History of myocardial infarction or stroke
5. History of malignancy within past 5 years (except for non-melanoma skin cancers)
6. Identification of any medical condition requiring immediate therapeutic intervention
7. Uncontrolled hypertension (resting brachial blood pressure equal or more than 160/100 mmHg)
8. History of severe liver disease
9. History of drug or alcohol abuse
10. Elective major surgery during the course of the study
11. Pregnancy and/ or lactation
12. Currently consuming nutraceutical supplements (especially vitamin C and D)
13. Participation or intention to participate in another clinical research study during the study period.
14. Not willing to take nutraceutical supplements (Thompson’s Super Bioflavonoid Complex 'Registered Trademark' and Thompson’s Cholesterol Manager 'Registered Trademark'), for 12 weeks.
15. Positive pregnancy test for the woman during their reproductive life.
16. Participants with impaired renal function.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our previous data shows that we had statistical significant changes in the levels of 8-OHdG and antioxidants using 40 T2DM patients. Based on these data and assuming 20-25% withdrawal rate from the study, for a two-sample test (t-test) with a Type I error of 5% (a = 0.05) and 80% power, we will require 50 participants in each group (both for aims 1 and aim 2)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
1/08/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 7607 0
Royal Hobart Hospital - Hobart
Recruitment hospital [2] 11642 0
Launceston General Hospital - Launceston
Recruitment postcode(s) [1] 15508 0
7000 - Hobart
Recruitment postcode(s) [2] 23689 0
7250 - Launceston

Funding & Sponsors
Funding source category [1] 295845 0
Charities/Societies/Foundations
Name [1] 295845 0
Tasmanian Community Fund
Country [1] 295845 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
School of Medicine,
Domain Campus,
Medical Science (Hollydene House - 310),
University of Tasmania
17 Liverpool Street, Private Bag 34
Hobart, TAS, 7001
Country
Australia
Secondary sponsor category [1] 294702 0
None
Name [1] 294702 0
Address [1] 294702 0
Country [1] 294702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297127 0
The Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 297127 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart, TAS, 7001
Ethics committee country [1] 297127 0
Australia
Date submitted for ethics approval [1] 297127 0
16/09/2016
Approval date [1] 297127 0
22/02/2017
Ethics approval number [1] 297127 0
H0015762

Summary
Brief summary
This study will investigate the potential of commercially available nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') is similar to the dipeptidyl peptidase-4 (DPP-4) inhibitor group, also known as gliptins, which are second line anti-diabetic drugs after metformin and sulfonylureas. The gliptins block the action of DPP-4, an enzyme which inhibits a group of gastrointestinal hormones called incretins which stimulate the production of insulin post meal and reduce the production of glucagon by the liver during digestion. DPP-4 inhibitors help regulate blood glucose levels by inhibiting incretins reducing the financial burden for antidiabetic medicine equivalent to AU$193.8 million per year.
This study aim:-
To determine the effect of nutraceutical supplement (Thompson’s Super Bioflavonoid Complex 'Registered Trademark') as natural DPP-4 inhibitor on glycemic control in patients with type 2 diabetes mellitus.

The study will include a total of 80 T2D participants recruited from the community. After an overnight fast (12-hr), participants will attend the clinical areas of the Medical Science Precinct, and the School of Health Sciences, University of Tasmania
(UTAS) to undergo the following:
1) Medical & lifestyle questionnaires
2) Anthropometrics
3) Blood tests to measure blood glucose, HbA1c, serum lipids, insulin, & oxidative markers.
4) Glucose metabolism (2hr oral glucose tolerance test).
5) Hemodynamic measures (blood pressure, heart rate & ECG).
6) Urinary electrolytes & kidney function.
7) Pregnancy test for woman during their reproductive life.

Venous blood & urine samples will be collected at the start and end of the two phases of the study. Nutraceutical supplements will be provided to the participants for 12 weeks. These natural products possess anti-diabetic activities & the suggested course of supplements will maintain a constant level of dosage of these nutraceutical supplements to improve the overall metabolic functions in T2D cohort.

Biomarkers of metabolic response included in this study include measuring 8-hydroxy deoxyguanosine (8-OHdG) (oxidative DNA damage), total lipid peroxidation (lipid peroxidation) & resistin (adipocytokine response).
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1559 1559 0 0
/AnzctrAttachments/372503-H15762 approval letter 170220.pdf (Ethics approval)
Attachments [2] 2972 2972 0 0
/AnzctrAttachments/372503-CBBS Participant Information Sheet- V7.pdf (Participant information/consent)
Attachments [3] 2973 2973 0 0
/AnzctrAttachments/372503-TSRAC - V7 with Changes.pdf (Protocol)

Contacts
Principal investigator
Name 73070 0
Dr Kiran Ahuja
Address 73070 0
School of Health Sciences, University of Tasmania, Room C127, Building C, Newnham Campus, TAS, Australia, postcode 7248.
Country 73070 0
Australia
Phone 73070 0
+613 6324 5478
Fax 73070 0
Email 73070 0
[email protected]
Contact person for public queries
Name 73071 0
Dr Kiran Ahuja
Address 73071 0
School of Health Sciences, University of Tasmania, Room C127, Building C, Newnham Campus, TAS, Australia, postcode 7248.
Country 73071 0
Australia
Phone 73071 0
+613 6324 5478
Fax 73071 0
Email 73071 0
[email protected]
Contact person for scientific queries
Name 73072 0
Dr Hayder Al-Aubaidy
Address 73072 0
School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, VIC, Australia, postcode 3086.
Country 73072 0
Australia
Phone 73072 0
+61 394798728
Fax 73072 0
Email 73072 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
To protect participant confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3087Ethical approval    372503-(Uploaded-15-07-2019-12-29-10)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.