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

Phase 4

Completed

• Conditions: Cognitive function; Mood; Neurological - Studies of the normal brain and nervous system; Mental Health - Studies of normal psychology, cognitive function and behaviour; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12618001682235
• Lead Sponsor: Bio and Gene

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Study Completion: 2019-10-24
• Last Update Posted: 11 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 73

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified