ANZCTR - Registration

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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

Secondary ID [1]

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

Blood absorption of fat-soluble nutrients

Condition category

Condition code

Alternative and Complementary Medicine

Herbal remedies

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Alternative and Complementary Medicine

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-te™ (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-te™ 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]

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]

Changes in plasma uptake of the supplement over a given period as measured by area under the curve calculations.

Timepoint [1]

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]

Maximum supplement plasma concentration (Cmax)

Timepoint [1]

Secondary outcome [2]

Time to maximum plasma concentration (Tmax)

Timepoint [2]

Secondary outcome [3]

Exploration of individual absorption data via mass spectrometry analysis of plasma samples for each participant.

Timepoint [3]

Secondary outcome [4]

Gastrointestinal tolerance assessed by use of gastrointestinal symptom questionnaire as validated by Pereira et al. BMC Gastroenterology 2014.

Timepoint [4]

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]

AUC of each formulation assessed by comparison of statistical results from analysis of plasma samples from each participant

Timepoint [5]

Secondary outcome [6]

Urinalysis for presence of supplement and their metabolites

Timepoint [6]

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?

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]

Commercial sector/Industry

Name [1]

Pharmako Biotechnologies Pty Ltd

Address [1]

Campbell Ave Cromer NSW 2099 AUS

Country [1]

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]

Commercial sector/Industry

Name [1]

Gencor Pacific

Address [1]

21E, Elegance Court Discovery Bay Lantau Island Hong Kong, Hong Kong

Country [1]

Hong Kong

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland human research ethics committee A

Ethics committee address [1]

Human Research Ethics Office,
UQ Research and Innovation, Cumbrae Stuart Building (72),
The University of Queensland, QLD, 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/11/2018

Approval date [1]

20/12/2018

Ethics approval number [1]

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

Dr David Briskey

Address

RDC Global Pty Ltd 3B/76 Doggett St Newstead, QLD, 4006

Country

Australia

Phone

+61 421 784 077

Fax

[email protected]

Contact person for public queries

Name

Amanda Rao

Address

RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006

Country

Australia

Phone

+61 414 488 559

Fax

[email protected]

Contact person for scientific queries

Name

David Briskey

Address

RDC Global Pty Ltd 3B/76 Doggett Street Newstead, QLD, 4006

Country

Australia

Phone

+61 421 784 077

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No IPD will be shared

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details	Attachment
2782	Study protocol	[email protected]	Study protocol documentation will be available by ... [More Details]
2783	Clinical study report	[email protected]	The clinical study report will be available by req... [More Details]
2897	Ethical 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

Source	Title	Year of Publication	DOI
Embase	Trans-resveratrol oral bioavailability in humans using lipisperseTM dispersion technology.	2020	https://dx.doi.org/10.3390/pharmaceutics12121190
Embase	A double-blind, randomised cross-over study to evaluate the absorption of a commercially available Ginkgo biloba extract compared to the liposomal extract Ginkgosome.	2022	https://dx.doi.org/10.1186/s12906-022-03679-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically