Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000701325
Ethics application status
Approved
Date submitted
7/05/2017
Date registered
16/05/2017
Date last updated
10/12/2019
Date data sharing statement initially provided
10/12/2019
Date results provided
10/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of ginseng consumption on innate immunity in healthy adults
Scientific title
Evaluating the effect of ginseng red berry supplementation on markers of innate immunity in healthy adults.
Secondary ID [1] 291873 0
None
Universal Trial Number (UTN)
U1111-1176-5576
Trial acronym
None
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Innate immunity 303162 0
Condition category
Condition code
Inflammatory and Immune System 302605 302605 0 0
Normal development and function of the immune system
Alternative and Complementary Medicine 302728 302728 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is aimed at evaluating the interrelationship between innate immunity and ginsenoside bioavailability. The trial is a double-blinded parallel design. This design was selected since this is a preliminary study and the time-dependent bioactivity of ginseng red berry metabolites within the body is currently unknown; a parallel design will eliminate any residual bioactivity of the ginseng or placebo.
Participants will be randomised into 2 groups; group 1 will consume a single dose of a ginseng red berry supplement containing 750 mg ginseng red berry extract, where as group 2 will consume a matched placebo, which will contain a cellulose food filler equivalent to the berry extract in the ginseng supplement. These supplements are made commerically by Natural F&P Corporation (South Korea) and meet both NZ and Korea food safety requirements for human consumption and will be adminstered to particpants as 3 tablets (each containing 250 mg ginseng red berry extract) with water.
This trial will take place in designated clinical facilities within PFR and be conducted by experienced trial co-ordinators, who are also First Aiders and trained phlebotomist. Particpants will be asked to initially donate a venous blood sample (~ 15 ml) and then consume a supplement (ginseng or placebo). They will then be asked to donate further venous blood samples at specific times (2, 5, 7, 9 and 24 hrs ) over the day. In addtion, participants will be asked to collect their urine (collecting devise and containers will be provided) for 24 hrs..
Intervention code [1] 297991 0
Treatment: Other
Comparator / control treatment
In this trial, we propose to use a matched placebo. This is prepared by the same company that prepared the ginseng red berry supplement (Natural F&P Corporation (South Korea). The control (placebo) supplement contains the same basic ingredients as the ginseng red berry supplement, but an equivalent amount (750mg) of crystalline cellulose 101 (common food filler) replaces the ginseng red berry extract.
Control group
Placebo

Outcomes
Primary outcome [1] 302021 0
Bioavailability plasma & urine profile of ginseng red berry ginsenoside metabolites will be analysed by either LC-MS or NMR spectroscopy methods developed by PFR. (i) NMR spectroscopy analysis, plasma will be diluted with buffered deuterated water (deuterium oxide) and directly analysed by NMR spectroscopic methods developed in collaboration with Dr Pat Edwards at Massey University. (ii) LC-MS analysis, protein-free plasma or urine will be fractionated through a series of solid phase extraction procedures following literature methods. The final extraction eluent containing the ginsenosides will be analysed by LC-MS. In both approaches, concentrations of ginsenosides will be calculated using authentic standards.
Timepoint [1] 302021 0
Plasma samples collected at 0, 2, 5, 7, 9 nd 24 hrs and urine samples collected between 0-3 hrs, 3-6 hrs, 6-12 hrs and 12-24 hrs.
Primary outcome [2] 302097 0
Innate immunity will be evaluated by immune responsiveness profiles in cell-based bioassays. Collected plasma be applied to cell assays evaluating (i) bacterial endotoxin-induced acute inflammatory response or (ii) the ability to up-regulation of anti-oxidant defence pathways. These bioassays will employ the measurement of inflammatory biomarkers (e.g. TNFa, IL-6, IL-10) measured using commerical ELISAs and by assessing the activation of the nrf2/ARE pathway in response to tBHQ in a gene-luciferase reporter cell bioassay.
Timepoint [2] 302097 0
Plasma samples collected at 0, 2, 5, 7, 9 and 24 hrs.
Secondary outcome [1] 334522 0
Systemic inflammatory biomarkers; plasma C-reactive protein, IL-6, using commercial ELISA kits,
Timepoint [1] 334522 0
Plasma collected at 0, 2, 5,7, 9 and 24 hrs will be used to measured the systemic indices listed above.
Secondary outcome [2] 334743 0
Systemic oxidative stress parameters; ROS, MDA and protein carbonyls, using PFR ‘in-house’ colorimetric bioassays and HPLC methodologies,
Timepoint [2] 334743 0
Plasma collected at 0, 2, 5,7, 9 and 24 hrs will be used to measured the systemic indices listed above.
Secondary outcome [3] 334744 0
Systemic antioxidant capacity; FRAP will be measured in plasma using PFR ‘in-house’ colorimetric kinetic bioassay, Antioxidant enzymes SOD & GPx activity will be measured in PBS-washed red blood cells using commercially bioassay kits.
Timepoint [3] 334744 0
Plasma collected at 0, 2, 5,7, 9 and 24 hrs will be used to measured the systemic indices listed above.

Eligibility
Key inclusion criteria
Healthy individuals (male or female) 16-65 yrs. Participants will be required to complete a health questionnaire and provide informed written consent for this study.
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling or unable to provide informed written consent or comply with study procedures. Participants will also be excluded if they have (i) known hypersensitivity or intolerance to ginseng (root or berry) products, (ii) health conditions that may their ability to regulate sugar digestion/absorption (i.e. diabetes, metabolic syndrome), (iii) suffer from regular headaches / migraines or trouble sleeping (insomnia) or (iv) have a health conditions that may affect ability to do computerised cognitive tasks (e.g., eye sight problems, colour blindness, aura migraines, epilepsy).
In addition, participants will be excluded if they are (a) pregnant or planning to get pregnant in the near future or have any of the following conditions: (b) blood borne diseases (e.g., hepatitis), (c) clinically diagnosed high/low blood pressure or heart disease, (d) regular gastrointestinal disturbances, i.e. dyspepsia, diarrhoea, (e) recent bacterial or viral illness, (f) autoimmune disorders such as rheumatoid arthritis, multiple sclerosis, (g) are taking any mediation that affects the properties of blood (e.g. blood clotting) or kidney function. In addition, potential volunteers will be excluded if they have donated blood within 4 weeks from the start of the study.

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)
Participants will be randomized in a 1:1 ratio into one of two nutritional supplementation groups (Ginseng or placebo) by a random number generator computer porgram.
An independent person will allocate the supplements into sealed envelope labelled with subject number. This will be given to the trial co-ordinator to give to the particpants during the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software - random number generator in window's excel program..
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All trial data will be captured on study specific visit worksheets and transcribed to an access database (Dotmatrix), held at PFR. The data will be analysed using Statistical Analysis Software (SAS) 9.1 for Windows (version 5.1.2600). Using a repeated measures analysis of variance (ANOVA), Comparison between supplementation groups over time for each measure (independent variable) will also be determined, providing levels of significance for trial effect, treatment effect, and interaction effect between sampling times. Post-hoc tests will also be performed to identify significant differences at each time point. Values will be presented as means +/- standard deviation (or standard error) at a 95% significance level (p = 0.05). Pearson’s Product Moment Correlation Coefficient’s may also be assessed using SPSS 15.0 for Windows to investigate if there are any relationships between certain variables by giving an R-value between 0.0 and 1.00 (or -0.0 and -1.00).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2017
Actual
22/06/2017
Date of last participant enrolment
Anticipated
2/10/2017
Actual
24/11/2017
Date of last data collection
Anticipated
6/11/2017
Actual
23/02/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 8883 0
New Zealand
State/province [1] 8883 0
Manawatu and Waikato

Funding & Sponsors
Funding source category [1] 296374 0
Other
Name [1] 296374 0
The Institute for Plant and Food Research Ltd.
Country [1] 296374 0
New Zealand
Primary sponsor type
Individual
Name
Jocelyn Eason
Address
The Institute for Plant and Food Research Ltd
Private Bag 11600
Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 295317 0
None
Name [1] 295317 0
Address [1] 295317 0
Country [1] 295317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297611 0
HDEC
Ethics committee address [1] 297611 0
Ethics committee country [1] 297611 0
New Zealand
Date submitted for ethics approval [1] 297611 0
09/05/2017
Approval date [1] 297611 0
22/06/2017
Ethics approval number [1] 297611 0

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

Contacts
Principal investigator
Name 74582 0
Dr Suzanne Hurst
Address 74582 0
The New Zealand Institute for Plant & Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 74582 0
New Zealand
Phone 74582 0
+ 64 (0) 6 355 6231
Fax 74582 0
Email 74582 0
[email protected]
Contact person for public queries
Name 74583 0
Suzanne Hurst
Address 74583 0
The New Zealand Institute for Plant & Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 74583 0
New Zealand
Phone 74583 0
+ 64 (0) 6 355 6231
Fax 74583 0
Email 74583 0
[email protected]
Contact person for scientific queries
Name 74584 0
Daryl Rowan
Address 74584 0
The New Zealand Institute for Plant & Food Research Ltd.
Private Bag 11600
Palmerston North 4442
Country 74584 0
New Zealand
Phone 74584 0
+64 (0) 6 953 7685
Fax 74584 0
Email 74584 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
Data only collected and analsysed as a whole (i.e. Ginseng vs. matched placebo).


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.