Effects and safety of three-weeks supplementation with Cera-Q (a silkworm cocoon extract) on memory and cognition in healthy adults.

Exclusion Criteria26

• Normal, or corrected to normal vision.
• Willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
• Willing to abstain from caffeine for 10 hours prior to and throughout the test visits, (up to 6 hours).
• Willing to abstain from alcohol for 24 hours and vigorous physical activity for 12 hours prior to all study visits.
• Current smoker
• 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).
• Cardiovascular disease.
• Uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure > 90 mm Hg)
• Neurological conditions including epilepsy, Parkinson’s disease, Myaesthenia Gravis, Huntington’s Chorea.
• History of dementia, stroke and other neurological conditions.
• Head trauma with loss of consciousness in the previous 6 months.
• History of anxiety, depression, or other psychiatric disorders requiring treatment in the last 2 years.
• Current endocrine, gastrointestinal or bleeding disorders.
• Current moderate or severe alcohol misuse disorder as defined in DSM5
• Current substance misuse disorder as defined in DSM5 (including misuse of prescription drugs)
• If female, pregnant or lactating.
• 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.
• 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
• Participation in any other study involving an investigational product in the preceding 4 weeks.