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Trial registered on ANZCTR


Registration number
ACTRN12620001179921
Ethics application status
Approved
Date submitted
8/10/2020
Date registered
9/11/2020
Date last updated
15/09/2023
Date data sharing statement initially provided
9/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind randomised controlled study to evaluate the effectiveness of a fermented red ginseng extract supplement (FermenGIN) compared to placebo on blood circulation parameters in an adult population.
Scientific title
A double-blind randomised controlled study to evaluate the effectiveness of a fermented red ginseng extract supplement (FermenGIN) compared to placebo on blood circulation parameters in an adult population.
Secondary ID [1] 302458 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BTCCIR-20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral blood circulation 319288 0
Condition category
Condition code
Cardiovascular 317251 317251 0 0
Other cardiovascular diseases
Alternative and Complementary Medicine 317252 317252 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The allocated product is to be taken in the morning orally with plain water. Participants will supplement daily for 8-weeks. FerminGIN is composed of fermented red ginseng extract (90%) and gamma-cyclodextrin (10%). Participants will take a daily dose of 700 mg (2 x 350 mg capsules), which includes 600 mg of FermenGIN and 100 mg of excipients.

If participants meet the inclusion criteria, they will be given a full explanation of the study requirements (PICF) and asked to complete the electronic consent form and enrolled into the study for 8-weeks. Enrolled participants will then be randomized (1:1) into one of two groups: FRG or placebo. Participants will then have baseline measures prior to starting product.

Following enrolment and while at the clinic, participants will complete the baseline measures. These include: questionnaires and a fasted blood test so that we can measure a range of other markers in the blood. At the end of the initial clinic visit participants will be given a referral to attend an external site (eg. QScan) to have an ultrasound of the right leg artery to assess blood flow. This scan is to be completed within 72 hours of the initial clinic appointment and prior to any trial supplement being consumed.

Following baseline data collection (including the leg ultrasound), participants will undertake 8-weeks of supplementation. During this period, participants will have a fasted blood sample and protocol monitoring measures taken at the midway point (4-weeks). During the week-4 visit, the final referral for a leg ultrasound will be provided to the participant. This is to be completed within the 8th week of the supplementation period and no later than 24 hours after finishing their final trial product dose. At the completion of the trial (week 8) participants will return to the study clinic and repeat the full baseline measures.

Throughout the 8-week trial, participants will complete exercise and food frequency recall at each clinic visit to monitor possible variables that could change cardiac function. Any product remaining at the conclusion of the study is to be disposed of.

Adherence will be monitored by capsule return at the end of the intervention period (8 weeks).
Intervention code [1] 318751 0
Treatment: Drugs
Comparator / control treatment
The placebo will be dosed in identical capsules as FRG using crystallized cellulose at 700 mg (2 x 350 mg per capsule). The placebo are to be stored in identical trial product containers at room temperature away from direct sunlight.
Control group
Placebo

Outcomes
Primary outcome [1] 325310 0
Change in Laser Doppler flowmetry as measured by ultrasound on right leg artery
Timepoint [1] 325310 0
Baseline and 8 Weeks
Secondary outcome [1] 387474 0
Change in platelet aggregation as measured by platelet aggregation assay
Timepoint [1] 387474 0
Baseline, Week 4 and Week 8
Secondary outcome [2] 387496 0
Change in blood pressure via automatic blood pressure machine
Timepoint [2] 387496 0
Baseline and week 8
Secondary outcome [3] 387497 0
Change in O2 saturation via oximeter
Timepoint [3] 387497 0
Baseline and week 8
Secondary outcome [4] 387498 0
Change in resting pulse rate via automatic blood pressure machine
Timepoint [4] 387498 0
Baseline and week 8
Secondary outcome [5] 387499 0
Change in vascular morphology and function (tibial artery diameter and blood flow) via vascular ultrasound
Timepoint [5] 387499 0
Baseline and Week 8
Secondary outcome [6] 387500 0
Change in biochemistry markers (Inflammation) as measured via plasma CRP and lipopolysaccharides
Timepoint [6] 387500 0
Baseline and week 8
Secondary outcome [7] 387501 0
Change in biochemistry markers (lipid profile) as measured via serum assay
Timepoint [7] 387501 0
Baseline and week 8
Secondary outcome [8] 387502 0
Change in biochemistry markers (safety markers- AST, ALT) via blood plasma and serum assay
Timepoint [8] 387502 0
Baseline and week 8
Secondary outcome [9] 387503 0
Change in anthropometry (weight as assessed but weighing scales and height as measured by stadiometer)
Timepoint [9] 387503 0
Baseline and week 8
Secondary outcome [10] 387504 0
Change in questionnaires Vascular Quality of life (VASCUQOL-6), Toronto Hospital Alertness Test (THAT) & SF-36 General Health questionnaire
Timepoint [10] 387504 0
Baseline and week 8

Eligibility
Key inclusion criteria
• Male and females aged 18 to 70 years
• Able to provide informed consent
• Agree not to change current diet or exercise level during the study period.
• Any three Indicators of the following five:
Serum triglyceride - greater than or equal to 150 mg/dL (greater than or equal to 1.7 mmol/L)
HDL-Cholesterol - less than or equal to 40 mg/dL(M), less than or equal to 50 mg/Dl(F)
less than or equal to 1.0 mmol/L (M), less than equal to 1.3 mmol/L (F)
Systolic blood pressure greater than or equal to 135 mmHg/
Diastolic blood pressure greater than or equal to 85 mmHg
Fasting blood glucose greater than or equal to 100 mg/dL (greater than or equal to 5.55 mmol/L)
Waist greater than or equal to 90 cm(M), 80 cm(F)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy)
• Malignancy or treatment for malignancy within the previous 2 years [this excludes non-melanoma (e.g. BCC and SCC) skin cancers not requiring radiation or chemotherapy]
• Receiving / prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy or substrates of P-glycoprotein including (but not limited to) calcium channel blockers, cyclosporin, digoxin, erythromycin and protease inhibitors.
• Use of other dietary supplements for circulation (e.g. fatty acids, CoQ10, L-arginine) or medications (e.g. Pentoxifylline and vasodilators like nitroglycerin) of a stable dose for less than 3 months
• Active smokers, nicotine, alcohol abuse (>14 alcoholic drinks week), drug abuse
• Allergic to any of the ingredients in active or placebo formula
• People suffering any neurological disorders such as MS
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Pregnant or lactating women
• Females of child bearing potential not using a highly effective form of contraception (b,c)(i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon)
• Those with a history of myocardial infarction, angina or bleeding disorders
• People who have uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) or diabetes mellitus (fasting glucose > 180mg/dl, or intake of hypoglycemic agents within 3 months prior to screening)
• Those who have uncontrolled thyroid diseases
• Those who consumed product that may affect the study within 2 weeks (e.g. red ginseng, ginseng, Natto, etc)
• Participants in another trial or had been in any other trial during last 30 days
• Those who have abnormal weight (BMI>35-<18.5 kg/m2)

a) A blood test will be performed when the participant has provided written consent following the PICF and study requirements having been read and explained to them. The signing of the consent form at this stage does not guarantee enrolment into the study.

b) Examples of acceptable forms of highly effective contraception include:
• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
• True abstinence: When this is in line with your preferred and usual lifestyle

c) Examples of non-acceptable methods of contraception include:
• Condoms alone or double barrier
• Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation)
• Withdrawal
• Spermicide (as it is not approved as a method of contraception in Australia)

It is the responsibility of the participant to ensure that prior to and during the trial, that if they intend to try to conceive, change birth control or if there is any chance they suspect they are pregnant, they notify the trial investigators immediately.

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)
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
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2021
Actual
17/02/2021
Date of last participant enrolment
Anticipated
Actual
31/01/2023
Date of last data collection
Anticipated
Actual
11/04/2023
Sample size
Target
80
Accrual to date
Final
183
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306885 0
Commercial sector/Industry
Name [1] 306885 0
BTC Corporation
Country [1] 306885 0
Korea, Republic Of
Primary sponsor type
Commercial sector/Industry
Name
RDC Global Pty Ltd
Address
3B/76 Doggett Street, Newstead QLD 4006
Country
Australia
Secondary sponsor category [1] 307443 0
Commercial sector/Industry
Name [1] 307443 0
BTC Corporation
Address [1] 307443 0
#703, Technology Development Centre, 705 Haean-ro, Sangnok-gu, Ansan-Si, Gyeonggi-do, 15588, Rep of Korea
Country [1] 307443 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307041 0
Bellberry Limited
Ethics committee address [1] 307041 0
Ethics committee country [1] 307041 0
Australia
Date submitted for ethics approval [1] 307041 0
29/06/2020
Approval date [1] 307041 0
08/10/2020
Ethics approval number [1] 307041 0

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

Contacts
Principal investigator
Name 105822 0
Dr David Briskey
Address 105822 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105822 0
Australia
Phone 105822 0
+61 421 784 077
Fax 105822 0
Email 105822 0
d.briskey@uq.edu.au
Contact person for public queries
Name 105823 0
Amanda Rao
Address 105823 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105823 0
Australia
Phone 105823 0
+61 414 488 559
Fax 105823 0
Email 105823 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 105824 0
Amanda Rao
Address 105824 0
RDC Global Pty Ltd
3B/76 Doggett Street
Newstead QLD 4006
Country 105824 0
Australia
Phone 105824 0
+61 414 488 559
Fax 105824 0
Email 105824 0
amanda@rdcglobal.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD will be shared


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.