None listed
Conditions
Brief summary
To Evaluate the Absorption Efficacy Characteristics and Further Safety Over a 6-hour period of Coenzyme Q10 [100 mg administered as ONE dose orally] from SIX study Preparations to Healthy Participants. The study aims to find out whether; 1) Different Over The Counter (OTC) Coenzyme Q10 products absorb differently as assessed by blood serum levels 2) Different modes of Coenzyme Q10 oral preparations [i.e. as a liquid or capsule] can provide the best delivery vechile 3) and what forms of Coenzyme Q10 such as liquids, capsules or other forms are acceptable to participants
Interventions
The aim of this study is to evaluate the absorption characteristics of a selected group of OVER THE COUNTER (OTC) Coenzyme Q10 PRODUCTS. ONE 100mg preparation will be self administered (orally) each day for SIX consecutive days. All participants will be allocated the same preparation each day, rotating products for six days. Endpoint Classification: Efficacy of Absorption / Safety Trial, Single Group Assignment, Masking; Open Label. Clinical Trial Coordinator to supervise dose administration and
The aim of this study is to evaluate the absorption characteristics of a selected group of OVER THE COUNTER (OTC) Coenzyme Q10 PRODUCTS. ONE 100mg preparation will be self administered (orally) each day for SIX consecutive days. All participants will be allocated the same preparation each day, rotating products for six days. Endpoint Classification: Efficacy of Absorption / Safety Trial, Single Group Assignment, Masking; Open Label. Clinical Trial Coordinator to supervise dose administration and any adverse effects. 1) Blackmores 1 capsule=100mg 2) Vitamin Shoppe 1 softgel=100mg 3) Solgar 1 veg capsule=100mg 4) Nature's Way 1 softgel=100mg 5) Jarrow 1 softgel=100mg 6) InMed Technologies LLC 2mL=100mg
Sponsors
Medlab Clinical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1) Participants 18 - 60 years of age at time of entry on study 2) No evidence or documented history of chronic disease 3) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment 4) Caucasian Ethnicity
Exclusion criteria
Any clinically abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: 1) Previous history of abnormal blood results i.e. FBE, U and E Liver Function Tests and vital signs 2) Use of vitamin or mineral supplements 1 week before the study and or known adverse side effects to supplements 3) Use of pharmaceutical drugs (prescribed or over-the-counter) 4) Female participants who are lactating or pregnant 5) The current use of any nicotine products including i) nicotine patches/gum ii) tobacco smoking 6) History of alcohol or substance abuse including the use of any illicit drugs 7) Presence of chronic/acute illnesses including hypertension, high cholesterol, diabetes, obesity, irritable bowel syndrome, inflammatory bowel disease, coeliac disease 8) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant (i.e. suicide thoughts or euthanasia requests) 9) Vegetarianism
Outcome results
None listed