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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
5/08/2022
Date data sharing statement initially provided
8/07/2019
Type of registration
Retrospectively 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
Alternative and Complementary Medicine 324413 324413 0 0
Other alternative and complementary medicine

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

A maximum of 610 male and female participants aged over 18 will be recruited locally from databases, fliers and public media outlets for a parallel study design.

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.

This trial comprises three investigational products (Resveratrol, Omega-3 and Ginkgo biloba) all in capsule form. Within each product, there may be more than 1 form to be tested. Resveratrol comprises 3 doses, each with an A and B group. Omega-3 comprises 3 products; fish oil with 3 doses, each with an A and B group, Krill oil with 1 dose with an A and B group and Algae oil with 7 doses, each with an A and B group. A total of 610 participants will be recruited to allow for withdrawals and maintain power.

1). Resveratrol
1. Standard (n=60 total)
a. 75 mg with AquaCelle
b. 75 mg without AquaCelle
2. Standard (n=60 total)
a. 100 mg Standard with AquaCelle
b. 100 mg Standard
3. Veri-teâ„¢ (n=60 total)
a. 150 mg Veri-te with AquaCelle
b. 150 mg Veri-te standard

2). Omega-3 oil
1. Fish oil (n=180 total)
a. 300 mg with AquaCelle
b. 300 mg Standard
c. 500 mg with AquaCelle
d. 500 mg Standard
e. 1,000 mg with AquaCelle
f. 1,000 mg Standard
2. Krill oil (n=60 total)
a. 150 mg with AquaCelle
b. 150 mg Standard
3. Algae oil dose response trial (n=70 total)
a. 300 mg (n=5)
b. 300 mg with AquaCelle (n=5)
c. 600 mg (n=5)
d. 600 mg with AquaCelle (n=5)
e. 900 mg (n=5)
f. 900 mg with AquaCelle (n=5)
g. 1200 mg (n=5)
h. 1200 mg with AquaCelle (n=5)
i. 1800 mg (n=5)
j. 1200 mg with AquaCelle (n=5)
k. 2100 mg (n=5)
l. 2100 mg with AquaCelle (n=5)
m. 2700 mg (n=5)
n. 2700 mg with AquaCelle (n=5)

3). Ginkgo biloba
1. Standard Ginkgo (n=60 total)
a. 160 mg
b. 120 mg (Blackmores tablet)
2. Liposomal Ginkgo (n=60 total)
a. Ginkgosome™ – 120 mg Ginkgo biloba extract
b. Virtiva – 120mg Ginkgo biloba extract

Veri-teâ„¢ is a commercial resveratrol product produced by Evolva SA.

Once enrolled in the trial, participants will be allocated one of the groups (e.g. A or B). Participants will be blinded to the make-up of the treatment. Prior to attending the clinic for the trial, participants will be mailed a urine collection kit to provide approximately 20 mL of mid-steam urine for testing of the supplement metabolites. This sample is to be collected on the morning of the clinic visit and returned to the clinic on the same day of testing. For 48 hours prior to the initial baseline blood draw participants will be provided with a list of foods to exclude from their diet. 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. A second urine sample will be provided on the morning of the 24-hour testing. 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 detailed in the table below. All meals and snacks for the first day will be provided.

Supplement Timing of blood draws post ingestion
Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours

The meals and food provided during the trial will be identical for each participant. The participants will be provided a list of foods to avoid for the duration of the study (specific to each supplement). This will conform to Australian dietary guidelines for adults. However, foods known to be high in the investigational product will be excluded.
Intervention code [1] 314788 0
Treatment: Other
Comparator / control treatment
Resveratrol comparator groups are 1..b., 2.b., and 3.b. which contain 75mg, 100mg and 150mg of resveratrol capsules without AquaCelle respectively.

Omega 3 (Fish oil) comparator groups are 1.b., 1.d., and 1.f. which contain 300mg, 500mg and 1000mg of Fish oil capsules without AquaCelle respectively.

Omega 3 (Krill oil) comparator group is 2b which contains 150mg of Krill oil capsules without AquaCelle.

Omega 3 (Algae oil) comparator groups are 3.a.., 3.c., 3.e., 3.g., 3.i., 3.k., 3.m. which contain 300mg, 600mg, 900mg, 1200mg, 1800mg, 2100mg, 2700mg of Algae oil capsules without Aquacelle respectively.

Ginkgo biloba comparator groups are 1.a., and 1.b. which contains 160mg and 120mg of ginkgo biloba respectively without Liposomal..
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
Timing post ingestion

Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
Secondary outcome [1] 371734 0
Maximum supplement plasma concentration (Cmax)
Timepoint [1] 371734 0
Timing post ingestion

Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
Secondary outcome [2] 371735 0
Time to maximum plasma concentration (Tmax)
Timepoint [2] 371735 0
Timing post ingestion

Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 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
Timing post ingestion

Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 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
Administered between the second last and last blood draw of the day. For resveratrol this is between the draws at 6 and 8 hours and for Fish oil and Ginkgo biloba between the draws at 10 and 12 hours.
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
Timing post ingestion

Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
Secondary outcome [6] 412608 0
Urinalysis for presence of supplement and their metabolites
Timepoint [6] 412608 0
Timing post ingestion

Resveratrol 0, 0.5, 1, 2, 3, 4, 5, 6, 8 and 24 hours
Omega-3 (fish, krill & algae oils) 0, 2, 4, 6, 8, 10, 12, 24 and 48 hours
Ginkgo biloba 0, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours

Eligibility
Key inclusion criteria
- Men and women aged over 18 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
19 Years
Maximum age
No limit
Sex
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
Recruiting
Date of first participant enrolment
Anticipated
15/07/2019
Actual
1/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
610
Accrual to date
120
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
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
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
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
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
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2782Study protocol  d.briskey@uq.edu.au Study protocol documentation will be available by ... [More Details]
2783Clinical study report  d.briskey@uq.edu.au The clinical study report will be available by req... [More Details]
2897Ethical approval    377816-(Uploaded-08-07-2019-09-21-02)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTrans-resveratrol oral bioavailability in humans using lipisperseTM dispersion technology.2020https://dx.doi.org/10.3390/pharmaceutics12121190
EmbaseA double-blind, randomised cross-over study to evaluate the absorption of a commercially available Ginkgo biloba extract compared to the liposomal extract Ginkgosome.2022https://dx.doi.org/10.1186/s12906-022-03679-x
N.B. These documents automatically identified may not have been verified by the study sponsor.