Coenzyme Q10 Blood Level Absorption Study in Healthy Adult Volunteers

Not Applicable

Withdrawn

• Conditions: CoQ10 deficiency; Diet and Nutrition - Other diet and nutrition disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12616001037493
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absorption Characteristics assessed in serum levels for each preparation[Blood test; blood sampling at baseline (0), 60, 180, 340 minutes post administration of oral dose of OTC (Coenzyme Q10). Absorption Characteristics will be assessed by Serum Tmax of CoQ10];acceptability (of different forms of CoQ10) to participants[60, 120, 240, 360 minutes post administration of CoQ10 via semi-structured interview]

Secondary Outcome Measures

Name	Time	Method
Safety - Documentation of any adverse events. Side effects may include: stomach upset, loss of appetite, nausea, vomiting, and diarrhoea. CTC to report participants post administration by direct observation [Clinical Trial Coordinator to document any adverse events: subject to participant. Continuous monitoring after dose administered to 6 hours each day.]