Bioavailability Study of CoQ10 Formulations in Healthy Elderly Adults
NCT ID: NCT03284814
Last Updated: 2019-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
21 participants
INTERVENTIONAL
2017-08-29
2017-10-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial to Assess the Pharmacokinetic Profile of Three Coenzyme Q10 Formulations in Healthy Adults
NCT07255079
Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations
NCT06640465
Bioavailability and Impact of Coenzyme Q10 in Stressing Exercise in Senescence Athletes
NCT03893864
Bioavailability of Ubiquinone and Ubiquinol in Older Adults
NCT03020680
Bioavailability Study of COQUN ORAL FORMULATION
NCT03819491
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Standard product group
This group will be included in a single dose cross over study, and in multiple dose study with standard product (SP: CoQ10 hard capsules; 100 mg)
Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Single dose intervention with Investigational product (IP)
syrup, 100 mg
Multiple dose intervention with Standard product (SP)
hard capsules, 100 mg - 14 days
Comparative product group
This group will be included in a single dose cross over study, and in multiple dose study with comparative product (CP: CoQ10 soft-gel capsules; 100 mg)
Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Single dose intervention with Investigational product (IP)
syrup, 100 mg
Multiple dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg - 14 days
Investigational product group
This group will be included in a single dose cross over study, and in multiple dose study with investigational product (IP: CoQ10 syrup; 100 mg)
Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Multiple dose intervention with Investigational product (IP)
syrup, 100 mg - 14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Single dose intervention with Standard product (SP)
hard capsules, 100 mg
Single dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg
Single dose intervention with Investigational product (IP)
syrup, 100 mg
Multiple dose intervention with Standard product (SP)
hard capsules, 100 mg - 14 days
Multiple dose intervention with Comparative product (CP)
soft-gel capsules, 100 mg - 14 days
Multiple dose intervention with Investigational product (IP)
syrup, 100 mg - 14 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged between 65 and 74 years at the time of the signature of ICF
* A body mass index between 20 and 29 kg/m2
* Healthy, meaning absence of any prescribed medication for a month prior to the inclusion to the study and during the study
* Willing to avoid a consumption of any food supplements except vitamin D and calcium at least 2 weeks before and during the study
* Consumption of dairy and cereal products (standardised breakfast will include low lactose dairy and bread)
* Willing to follow all study procedures, including attending all site visits (including sessions during which a venous line will be inserted for blood sampling), and keeping a diary for the time of multiple-dose study (to follow their compliance and palatability)
Exclusion Criteria
* Intake of any food supplements within 2 weeks of the beginning of the study, except vitamin D and calcium
* Hypotension
* Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease, diabetes
* Gastrointestinal disorders or other serious acute or chronic diseases
* Known lactose/gluten intolerances/ food allergies (limitation for standardisation of meals)
* Inadequate veins (in the opinion of the investigator) or known contraindication to placement of a dedicated peripheral line for venous blood withdrawal
* Known drug and/or alcohol abuse
* Using any form of nicotine or tobacco
* Mental incapacity that precludes adequate understanding or cooperation
* Participation in another investigational study or blood donation within 3 months prior to or during this study
65 Years
74 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vizera d.o.o.
INDUSTRY
Valens Int. d.o.o., Slovenija
INDUSTRY
MEDEDUS, Ljubljana, Slovenia
UNKNOWN
Institute of Nutrition, Slovenia (Nutris)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Snežana Kocijančič
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Igor Pravst
Role: PRINCIPAL_INVESTIGATOR
Nutrition Institute, Ljubljana
Snežana Kocijančič
Role: PRINCIPAL_INVESTIGATOR
MEDEDUS, Ljubljana, Slovenia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MEDEDUS, Ljubljana, Slovenia
Ljubljana, , Slovenia
Nutrition Institute, Ljubljana
Ljubljana, , Slovenia
Vizera d.o.o., Ljubljana, Slovenia
Ljubljana, , Slovenia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KME 89/07/17
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.