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Trial registered on ANZCTR


Registration number
ACTRN12619000953134
Ethics application status
Approved
Date submitted
21/06/2019
Date registered
8/07/2019
Date last updated
8/07/2019
Date data sharing statement initially provided
8/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.
Scientific title
A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.
Secondary ID [1] 298538 0
Nil known
Universal Trial Number (UTN)
Trial acronym
UQ-PK19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood absorption of antioxidants 313356 0
Blood absorption of fat-soluble nutrients 313471 0
Condition category
Condition code
Alternative and Complementary Medicine 311796 311796 0 0
Herbal remedies
Metabolic and Endocrine 311901 311901 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.

A maximum of 180 male and female participants aged over 18 will be recruited locally from databases, fliers and public media outlets. Following preliminary screening via telephone, potential participants will attend an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, physical assessment (e.g. height, weight) and medical history; this data will be used for comprehensive screening and to provide contextual data for the study.

The investigational product is a commercially available capsule-form herbal medicine containing resveratrol. There are 6 groups within the study which are detailed below.

1. 75 mg Resveratrol without aquacelle
2. 75 mg Resveratrol with aquacelle
3. 100 mg Resveratrol without aquacelle
4. 100 mg Resveratrol with aquacelle
5. 150 mg Resveratrol without aquacelle
6. 150 mg Resveratrol with aquacelle

Once enrolled in the trial, participants will be allocated to one of the six groups. Participants will be blinded to the make-up of the treatment. For 48 hours prior to the initial baseline blood draw, participants will be provided with a list of foods to exclude from their diet. Each participant will be reminded via email to exclude these foods from their diet during the pre-testing phase. On the day prior to the baseline blood draw participants will be instructed to not eat or drink anything other than water after 10pm. On day one of the study a fasting blood sample will be taken upon each participant’s arrival at the clinic beginning at approximately 7:30am. Participants will then be provided the allocated treatment dose to take with a cup (240 mL) of plain water. Within 30 minutes of taking the product, a standardised breakfast meal will be served to each participant. The standardised breakfast will include toast (white and wholemeal) with jam, Vegemite or peanut butter, cereal, yoghurt and fruit. A maximum of 10 blood samples will then be taken over a period of up to 48 hours. The exact timing of the blood draws are at 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours. All meals and snacks for the first day will be provided.The meals and food provided during the trial will be identical for each participant.





Intervention code [1] 314788 0
Treatment: Other
Comparator / control treatment
The comparator groups are 1, 3 and 5 which contain 75mg, 100mg and 150mg of resveratrol without aquacelle respectively, to be taken at baseline with water. After which a standardised breakfast meal will be provided to each participant.
Control group
Dose comparison

Outcomes
Primary outcome [1] 320471 0
Changes in plasma uptake of the supplement over a given period as measured by area under the curve calculations.
Timepoint [1] 320471 0
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 and 48 hours
Secondary outcome [1] 371734 0
Maximum supplement plasma concentration (Cmax)
Timepoint [1] 371734 0
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 and 48 hours
Secondary outcome [2] 371735 0
Time to maximum plasma concentration (Tmax)
Timepoint [2] 371735 0
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 and 48 hours
Secondary outcome [3] 371737 0
Exploration of individual absorption data via mass spectrometry analysis of plasma samples for each participant.
Timepoint [3] 371737 0
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 and 48 hours
Secondary outcome [4] 371738 0
Gastrointestinal tolerance assessed by use of gastrointestinal symptom questionnaire as validated by Pereira et al. BMC Gastroenterology 2014.
Timepoint [4] 371738 0
24 and 48 hours post enrolment
Secondary outcome [5] 371739 0
AUC of each formulation assessed by comparison of statistical results from analysis of plasma samples from each participant
Timepoint [5] 371739 0
0, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 and 48 hours

Eligibility
Key inclusion criteria
- Men and women aged 18-40 years with normal dietary habits (no medically prescribed diet or slimming diet) including good representation of age and gender specifics.
- Clinically healthy, BMI 18.5-39.9
- No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- Participant’s full agreement and ability to consent to participation in the study
- Participant’s ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points.
- Female participants must be on a form of prescribed birth control (e.g. oral contraceptive pill)
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Allergy to the investigational material
- Previous history of hematologic diseases (e.g. known susceptibility to thrombosis)
- Concomitant use of anticoagulant drugs (e.g. Warfarin Sodium) and any other prescribed medication (not for control of previously mentioned conditions above) expect for females on the oral contraceptive pill
- Female participants currently pregnant, lactating or undergoing fertility treatment
- Regular use of supplements containing the investigational material (e.g. omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3, red meat and eggs for CoQ10)
- High alcohol consumption (equal to 21 standard drinks/week)
- Reported participation in another trial 1 month before the start of the study
- Recent history (within 12 months) of substance abuse including alcohol
- Development of serious, adverse events/reactions including but not limited to; fainting, life-threating dehydration and/or serious bruising from blood sampling, excessive and prolonged diarrhoea or gastrointestinal upset from fish oil consumption.
- Received treatment (radio &/or chemotherapy) for cancer (excluding BCC skin cancer) in past 2 years.
- Current smoker.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 303084 0
Commercial sector/Industry
Name [1] 303084 0
Pharmako Biotechnologies Pty Ltd
Address [1] 303084 0
Campbell Ave Cromer NSW 2099 AUS
Country [1] 303084 0
Australia
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] 303067 0
Commercial sector/Industry
Name [1] 303067 0
Gencor Pacific
Address [1] 303067 0
21E, Elegance Court Discovery Bay Lantau Island Hong Kong, Hong Kong
Country [1] 303067 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303629 0
The University of Queensland human research ethics committee A
Ethics committee address [1] 303629 0
Human Research Ethics Office,
UQ Research and Innovation, Cumbrae Stuart Building (72),
The University of Queensland, QLD, 4072
Ethics committee country [1] 303629 0
Australia
Date submitted for ethics approval [1] 303629 0
07/11/2018
Approval date [1] 303629 0
20/12/2018
Ethics approval number [1] 303629 0

Summary
Brief summary
A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94322 0
Dr David Briskey
Address 94322 0
RDC Global Pty Ltd 3B/76 Doggett St Newstead, QLD, 4006
Country 94322 0
Australia
Phone 94322 0
+61 421 784 077
Fax 94322 0
Email 94322 0
d.briskey@uq.edu.au
Contact person for public queries
Name 94323 0
Ms Amanda Rao
Address 94323 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 94323 0
Australia
Phone 94323 0
+61 414 488 559
Fax 94323 0
Email 94323 0
amanda@rdcglobal.com.au
Contact person for scientific queries
Name 94324 0
Dr David Briskey
Address 94324 0
RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006
Country 94324 0
Australia
Phone 94324 0
+61 421 784 077
Fax 94324 0
Email 94324 0
d.briskey@uq.edu.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?
Study protocol
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2782 0
Study protocol
Citation [1] 2782 0
Link [1] 2782 0
Email [1] 2782 0
d.briskey@uq.edu.au
Other [1] 2782 0
Study protocol documentation will be available by request from the primary investigator as this documentation contains commercially sensitive information and will not be published until completion of the study. The primary sponsor holds the rights to the intellectual property of this documentation.
Attachment [1] 2782 0
Type [2] 2783 0
Clinical study report
Citation [2] 2783 0
Link [2] 2783 0
Email [2] 2783 0
d.briskey@uq.edu.au
Other [2] 2783 0
The clinical study report will be available by request from the primary investigator as this documentation contains commercially sensitive information and will not be published until completion of the study. The primary sponsor holds the rights to the intellectual property of this documentation.
Attachment [2] 2783 0
Type [3] 2897 0
Ethical approval
Citation [3] 2897 0
Link [3] 2897 0
Email [3] 2897 0
Other [3] 2897 0
Summary results
No Results