Clinical trial NCT02604641: Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin
Official title: Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkles
Ageing
Photoprotection
Keywords: skin rejuvenation
anti-ageing effects
minimal erythema dose
dermis structure
physiological skin condition
wrinkling
dry skin
Lead sponsor: VIST - Faculty of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Valens Int. d.o.o., Slovenija
name: Nutrition Institute, Slovenia
First posted: 2015-11-13
Enrollment: 33
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Objective of the study is to determine the influence of dietary supplementation with coenzyme Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. Various skin parameters will be evaluated before the supplementation (the baseline), after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the supplementation.

Detailed description: Objective of the study is to determine the influence of dietary supplementation of CoQ10 in form of water-soluble Q10vital® on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. The placebo or CoQ10 will be administered in the form of a syrup; all subjects will consume 5 mL of syrup daily for 12 weeks. The photoprotective potential of CoQ10 will be evaluated with a determination of the minimal erythema dose (MED) before (the baseline) and after 12 weeks of the supplementation. Other skin parameters will be evaluated before supplementation (the baseline), after 6 and after 12 weeks of supplementation. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.

Eligibility criteria: Inclusion Criteria:

* Signs of skin aging (mimic wrinkles/ poor skin tone/ visual dryness),
* Photoaged skin on the face,
* Expression of mimic wrinkles,
* Phototype II and III.

Exclusion Criteria:

* Allergy to ingredients of tested products
* High blood cholesterol and use of cholesterol-lowering medicines,
* Diagnosed diabetes
* Thyroid disease
* Inflammatory skin diseases,
* Regular use of dietary supplements 6 months or less before start of the study,
* Invasive rejuvenation treatments (botox injections, hyaluronic acid fillers, needle rollers, needle mesotherapy, etc.) 6 months or less prior to start of the study,
* Non-invasive rejuvenation treatments (radiofrequency, electrotherapy, ultrasound therapy, no-needle mesotherapy, etc.) 6 months or less prior to start of the study,
* The use of cosmetic products containing coenzyme Q10 6 months or less prior to start of the study,
* Gluteal hyperpigmentation,
* Expected sunbathing (also in solariums) within the study period.

Primary outcomes:
measure: Improvement of photoprotective function of the skin
timeFrame: after 12 weeks of the supplementation
Secondary outcomes:
measure: Reduction of the area of the periorbital facial wrinkles
timeFrame: after 6 and after 12 weeks of the supplementation
measure: Reduction of the volume of the periorbital facial wrinkles
timeFrame: after 6 and after 12 weeks of the supplementation
measure: Reduction of wrinkles at different face areas
timeFrame: after 6 and after 12 weeks of the supplementation
measure: Improvement of the dermis structure
timeFrame: after 6 and after 12 weeks of the supplementation
measure: An increase of the dermis thickness
timeFrame: after 6 and 12 weeks of the supplementation
Other outcomes:
Locations:
Study officials:
affiliation: VIST - Faculty of Applied Sciences
name: Janko Zmitek, PhD
role: STUDY_CHAIR
affiliation: VIST - Faculty of Applied Sciences
name: Katja Zmitek, PhD
role: STUDY_DIRECTOR
affiliation: UL MF
name: Liljana Mervic, PhD
role: STUDY_CHAIR
affiliation: VIST - Faculty of Applied Sciences
name: Tina Tina Pogačnik, BSc
role: PRINCIPAL_INVESTIGATOR
References: