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Trial registered on ANZCTR


Registration number
ACTRN12618001682235
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
11/10/2018
Date last updated
12/12/2018
Date data sharing statement initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects and safety of three-weeks supplementation with Cera-Q (a silkworm cocoon extract) on memory and cognition in healthy adults.
Scientific title
Investigating the safety and efficacy of chronic administration of Cera-Q on memory and cognitive function in healthy adults.
Secondary ID [1] 295921 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function 309409 0
Mood 309410 0
Condition category
Condition code
Neurological 308264 308264 0 0
Studies of the normal brain and nervous system
Mental Health 308265 308265 0 0
Studies of normal psychology, cognitive function and behaviour
Alternative and Complementary Medicine 308266 308266 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive either the active or placebo treatment for 3 weeks. Participants will undergo assessments of efficacy and safety at baseline and 3-weeks follow-up. A screening and practice visit will also be conducted to ensure participants meet the eligibility criteria and familiarise them with the study procedures.

The active treatment consists of capsules containing 166.6mg Cera-Q, 71.4mg dextrin and 2mg magnesium stearate. Participants are required to consume 6 capsules daily to give a total intake of 1000mg Cera-Q. Participants will be instructed to take 3 capsules in the morning and 3 in the evening, with food.

Participants will be provided with a treatment log to record when they have taken their treatment each day. In addition, they will be asked to return all bottles and unused treatment at their final visit so that compliance can be calculated based on a capsule count.

Intervention code [1] 312244 0
Treatment: Other
Comparator / control treatment
The placebo capsules are identical in size, shape and colour to the active treatment, but contain only dextrin (223mg) and magnesium stearate (2mg). Participants are required to take 6 capsules daily.
Control group
Placebo

Outcomes
Primary outcome [1] 307235 0
Change from baseline in Long term memory, assessed using score on Rey's Auditory Verbal Learning Test (RAVLT).
Timepoint [1] 307235 0
3 weeks post first dose
Primary outcome [2] 307743 0
Change from baseline in Long term memory, assessed using score on the Wechsler Memory Scales (WMS-IV).
Timepoint [2] 307743 0
3 weeks post first dose
Secondary outcome [1] 351211 0
Change from baseline in attention, measured using the CogTrack computerised cognitive testing battery
Timepoint [1] 351211 0
3 weeks post first dose
Secondary outcome [2] 351212 0
Change from baseline in attention measured using the digit span test
Timepoint [2] 351212 0
3 weeks post first dose
Secondary outcome [3] 351213 0
Change from baseline in processing speed measured using the CogTrack computerised cognitive testing battery.
Timepoint [3] 351213 0
3 weeks post first dose
Secondary outcome [4] 351258 0
Change from baseline in processing speed measured using tasks from the Neuropsychological Battery (Coding, Cancellation and Symbol Search tests).
Timepoint [4] 351258 0
3 weeks post first dose

Eligibility
Key inclusion criteria
People who meet the following inclusion criteria will be included in the trial:
1. Male or female, aged 18-70 years, inclusive.
2. Willing and able to provide written informed consent.
3. Understands and is willing and able to comply with all study procedures.
4. Fluent in written and spoken English.
5. In good general health as judged by the Investigator/Clinical advisor on the basis of medical history and absence of exclusion criteria
6. Normal, or corrected to normal vision.
7. Willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
8. Willing to abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 6 hours).
9. Willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who meet the following exclusion criteria will not be included in the trial:
1. Current smoker
2. History of Type I diabetes (insulin dependent) or Type II diabetes on treatment. (Type II diabetes and prediabetes treated with diet alone is not an exclusion).
3. Cardiovascular disease.
4. Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 90 mm Hg)
5. Neurological conditions including epilepsy, Parkinson’s disease, Myaesthenia Gravis, Huntington’s Chorea.
6. History of dementia, stroke and other neurological conditions.
7. Head trauma with loss of consciousness in the previous 6 months.
8. History of anxiety, depression, or other psychiatric disorders requiring treatment in the last 2 years.
9. Current endocrine, gastrointestinal or bleeding disorders.
10. Current moderate or severe alcohol misuse disorder as defined in DSM5
11. Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
12. If female, pregnant or lactating.
13. Not willing to abstain from using vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, or other cognitive enhancing dietary or herbal supplements over the study period.
14. Taking the following in the 4 weeks preceding the baseline study visit:
i. Vitamin supplements including multivitamins, B vitamin complex, vitamin E
ii. Herbal supplements including ginkgo biloba, fish oil, St John’s Wort or other cognitive enhancing dietary or herbal supplement
iii. Anti-coagulant drugs (warfarin, heparin, clopidogrel, aspirin, dipyrimidole, apixiban , rivaroxiban, dabigatran, tirofiban , ticagrelor);
iv. anti-cholinergics or acetylcholinesterase inhibitors (bethanechol (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), pyridostigmine (Mestinon)
v. anti-depressant medications
vi. anti-anxiety medication including benzodiazepines
vii. Hypnotics including benzodiazepines, zolpidem and zopiclone
15. Participation in any other study involving an investigational product in the preceding 4 weeks.

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)
Allocation to treatment is concealed through the use of sealed opaque envelopes and a password protected electronic document.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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)
VIC

Funding & Sponsors
Funding source category [1] 300519 0
Commercial sector/Industry
Name [1] 300519 0
Bio and Gene
Address [1] 300519 0
8 West Street
North Sydney,
NSW 2060,
Australia
Country [1] 300519 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bio and Gene
Address
8 West Street
North Sydney,
NSW 2060,
Australia
Country
Australia
Secondary sponsor category [1] 300402 0
None
Name [1] 300402 0
Address [1] 300402 0
Country [1] 300402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301309 0
Bellberry HREC
Ethics committee address [1] 301309 0
129 Glen Osmond Rd
Eastwood
Adelaide
South Australia
5063
Ethics committee country [1] 301309 0
Australia
Date submitted for ethics approval [1] 301309 0
20/06/2018
Approval date [1] 301309 0
22/10/2018
Ethics approval number [1] 301309 0
2018-05-394
Ethics committee name [2] 302166 0
Swinburne University Human Research Ethics Committee EC00240
Ethics committee address [2] 302166 0
PO Box 218
Hawthorn
VIC 3122
Ethics committee country [2] 302166 0
Australia
Date submitted for ethics approval [2] 302166 0
01/11/2018
Approval date [2] 302166 0
05/11/2018
Ethics approval number [2] 302166 0
SHR Project 2018/399

Summary
Brief summary
The purpose of this research project is to determine the effects and safety of Cera-Q on memory, cognitive function and mood. With Australia's increasingly ageing population, interventions capable of ameliorating age-related neurocognitive change are becoming vital areas of research. In addition to pharmacological interventions, nutritional supplements such as silk fibroin proteins provide an alternative way for maintaining optimal health, including brain health.

This study will be the first study in Australia to assess the effectiveness and safety of Cera-Q on cognitive function and mood. Cera-Q is an extract of fibroin protein from silkworm (Bombyx mori) cocoon, and is available commercially in the Republic of Korea and the United States of America. It is a bioactive peptide (protein fragment formed by amino acids) suggested to support brain/cognitive function. Whilst the exact composition of this product may be slightly different to others used in animal and human studies, several studies of the effects of fibroin proteins from silkworm cocoon have shown positive effects on cognitive function. We will be measuring the effects and safety of Cera-Q compared to a placebo using assessments of mental performance and mood, along with the collection of blood samples.

Seventy-five participants will be enrolled into this trial, in order to obtain a sample of 60 participants who will complete the trial. Bio and Gene Pty Ltd. are covering all of the costs of this study and providing the products to Swinburne University for the purpose of this research project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86582 0
Prof Con Stough
Address 86582 0
Mailbox H24
Swinburne University of Technology
Centre for Human Psychopharmacology
PO Box 218
Hawthorn
VIC 3122
Country 86582 0
Australia
Phone 86582 0
+61 3 9214 8167
Fax 86582 0
Email 86582 0
cstough@gmail.com
Contact person for public queries
Name 86583 0
Dr Naomi Perry
Address 86583 0
Mailbox H24
Swinburne University of Technology
Centre for Human Psychopharmacology
PO Box 218
Hawthorn
VIC 3122
Country 86583 0
Australia
Phone 86583 0
+61 3 9214 8930
Fax 86583 0
Email 86583 0
nlperry@swin.edu.au
Contact person for scientific queries
Name 86584 0
Prof Con Stough
Address 86584 0
Mailbox H24
Swinburne University of Technology
Centre for Human Psychopharmacology
PO Box 218
Hawthorn
VIC 3122
Country 86584 0
Australia
Phone 86584 0
+61 3 9214 8167
Fax 86584 0
Email 86584 0
cstough@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
As is typical for this type of trial, group data will be analysed to answer the research questions rather than individual data. It is expected that the findings will be presented in a peer reviewed journal and at academic conferences. If it is a requirement of the journal, de-identified raw data will be made available.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable