Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000702314
Ethics application status
Approved
Date submitted
7/05/2017
Date registered
16/05/2017
Date last updated
28/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of ginseng consumption on sugar metabolism & cognitive function in healthy adults
Scientific title
Effect of ginseng red berry supplementation on glucose metabolism and cognitive function in healthy adults.
Secondary ID [1] 291874 0
None
Universal Trial Number (UTN)
U1111-1176-5576
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sugar metabolism 303163 0
Cognitive performance 303273 0
Condition category
Condition code
Metabolic and Endocrine 302606 302606 0 0
Normal metabolism and endocrine development and function
Mental Health 302700 302700 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 302729 302729 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial is aimed at assessing how ginseng red berry supplementation (24 hr post-consumption) influences glucose metabolism and cognitive function. 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 trial design will eliminate any potential problems from a cross-over design.
Participants will be randomised into 2 groups; group 1 will consume a single dose of ginseng red berry supplement containing 750 mg ginseng red berry extract, whereas group 2 will consume a matched placebo containing a cellulose food filler equivalent to the amount of ginseng red berry extract. These supplements are prepared commercially by Natural F&P Corporation (South Korea) and meet both Korea and New Zealand food safety requirements for human consumption and administered to the participants in the form of 3 tablets (each containing 250 mg ginseng red berry extract) with water.
The trial will take place in designated clinical facilitates within PFR and will be conducted by experience trial co-ordinators, who are also First Aider and trained phlebotomist.
This trial will consist of 3 sessions, each of which will be carried out over 3 days; session 1 (familiarisation session) and session 1 and 2 (main trial sessions. Briefly, in session 1, participants will be asked to consuming a sugar drink (containing 60 g sucrose) and at specific times over the next 2 hrs blood sugar metabolites will be measured. In session 2, participants will initially be asked to complete a mood questionnaire (POMS), followed by consuming a sugar drink (containing 60 g sucrose). At specific times over the next 2 hrs blood sugar metabolites will be measured. In addition, after 15mins, the participants will be asked to complete a series of computerised mental tasks (takes about 7 mins). After the 2hrs, participants will then be asked to consume a ginseng or placebo supplement and asked to return 24 hrs later to complete session 3. In session 3, participants are asked to repeat the assessments of session 2 without the consumption of ginseng.
Intervention code [1] 297992 0
Treatment: Other
Comparator / control treatment
In this trial we propose to use a matched placebo. This is prepared by the same company that made 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 (750 mg) of crystalline cellulose 101 (common food filler) replaces the ginseng red berry extract.
Control group
Placebo

Outcomes
Primary outcome [1] 302022 0
Sugar metabolism parameters: Collected blood samples will be processed and analysed for glucose, lactate and HbA1c using “point-of-test” biosensors. Plasma samples collected will also be measured for ATP, insulin, glucagon using commercial ELISA kits.
Timepoint [1] 302022 0
Sugar metabolism parameters. This will be measured in all three trial session; (session 1 - familiarisation, session 2- pre ginseng consumption and session 3 - 24 hrs post ginseng consumption). Specifically HbA1c prior to consumption of the sugar (60 g sucrose)drink, whereas the other indices will be measured at specific times after the consumption of the sugar drink over 2 hrs; 0, 5, 15, 30, 45, 60, 90 & 120 mins.
Primary outcome [2] 302098 0
Computerised cognitive tasks: This computerised test (commerically available /validated and known as 'Joggle') will be performed by the trial participants using an iPad. The 'joggle' cognitive function test composes of 8 individual tasks, which assesses the following skills; motor praxis, visual object learning, working memory, abstract matching, line orientation, digital symbol substitution, balloon analogue risk and psychomotor vigilance. These tasks are randomised to prevent a learning effect.
Timepoint [2] 302098 0
Computerised cognitive tasks: This will be measured in sessions 2 (pre-ginseng consumption) and 3 (24 hrs post-ginsneg consumption). Specifically particpants will be asked to complete a series of computer taks on an iPad 15 min after the consumption of the sugar drink.
Primary outcome [3] 302099 0
Perceived physical and cognitive assessment POMS): Participants will be asked to complete a questionnaire assessing PoMS
Timepoint [3] 302099 0
Perceived physical and cognitive assessment POMS): Particpants will be asked to complete this form at the beginning of sessions 2 (pre-ginseng consumption) and 3 (24 hrs post ginseng consumption).
Secondary outcome [1] 334523 0
Blood biochemical measurements: Collected venous blood will be used to measure brain wellness biomarker BDNF.
Timepoint [1] 334523 0
Blood biochemical measurements: BDNF will be measured in venous plasma samples collected before the start of sessions 2 (pre-ginseng consumption) and 3 (24 hrs post ginseng consumption).

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 randomised in a 1:1 ratio into one of two nutritional supplementation groups (ginseng or placebo) by a random number generator computer program.
An independent person will allocate the supplements into sealed envelopes labelled with subject number. This will then be given to the trial co-ordinator to give to the participants 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 sorware - 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 trial 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 feeding conditions. 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
Recruiting
Date of first participant enrolment
Anticipated
5/06/2017
Actual
22/06/2017
Date of last participant enrolment
Anticipated
2/10/2017
Actual
Date of last data collection
Anticipated
6/11/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8884 0
New Zealand
State/province [1] 8884 0
Manawatu and Waikato

Funding & Sponsors
Funding source category [1] 296375 0
Other
Name [1] 296375 0
The Institute for Plant and Food Research Ltd.
Country [1] 296375 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] 295318 0
None
Name [1] 295318 0
Address [1] 295318 0
Country [1] 295318 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297612 0
HDEC - Central ethics committee
Ethics committee address [1] 297612 0
Ethics committee country [1] 297612 0
New Zealand
Date submitted for ethics approval [1] 297612 0
09/05/2017
Approval date [1] 297612 0
22/06/2017
Ethics approval number [1] 297612 0
17/CEN/86

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

Contacts
Principal investigator
Name 74586 0
Dr Suzanne Hurst
Address 74586 0
The New Zealand Institute for Plant and Food Research
Private Bag 11600
Palmerston North 4442
Country 74586 0
New Zealand
Phone 74586 0
+ 64 (0) 6 355 6231
Fax 74586 0
Email 74586 0
[email protected]
Contact person for public queries
Name 74587 0
Suzanne Hurst
Address 74587 0
The New Zealand Institute for Plant and Food Research
Private Bag 11600
Palmerston North 4442
Country 74587 0
New Zealand
Phone 74587 0
+ 64 (0) 6 355 6231
Fax 74587 0
Email 74587 0
[email protected]
Contact person for scientific queries
Name 74588 0
Daryl Rowan
Address 74588 0
The New Zealand Institute for Plant and Food Research
Private Bag 11600
Palmerston North 4442
Country 74588 0
Albania
Phone 74588 0
+64 (0) 6 953 7685
Fax 74588 0
Email 74588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23517Other    Presentation of their data will given to the parti... [More Details]
23812Other    Participants will be provided with data that shows... [More Details]

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4052Plain language summaryNo Preliminary findings from this study indicate that... [More Details]

Documents added automatically
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