None listed
Conditions
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.
Interventions
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 ca
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.
Sponsors
Bio and Gene
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed