Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin

Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Wrinkles; Ageing; Photoprotection
• Intervention / Treatment: Dietary supplement: Placebo group; Dietary supplement: Quvital LD group; Dietary supplement: Quvital HD group

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo group; 0 mg CoQ10 daily	Dietary supplement: Placebo group; Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.
ACTIVE_COMPARATOR: Quvital LD group; 50 mg CoQ10 daily	Dietary supplement: Quvital LD group; Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.
ACTIVE_COMPARATOR: Quvital HD group; 150 mg CoQ10 daily	Dietary supplement: Quvital HD group; Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of photoprotective function of the skin	Minimal erythema dose (MED) of the skin will be determined. Skin on gluteal part of the body will be exposed to 10 different doses of UVB light and 24 hours after exposure MED will be determined.Higher MED indicates better photoprotective function of the skin.	after 12 weeks of the supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of the area of the periorbital facial wrinkles	Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.	after 6 and after 12 weeks of the supplementation
Reduction of the volume of the periorbital facial wrinkles	Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.	after 6 and after 12 weeks of the supplementation
Reduction of wrinkles at different face areas	Expert assessment of wrinkles at different face areas (periorbital, frontal, glabelar, nasolabial areas etc.) will be done according to Lemperle Wrinkle assessment scale.	after 6 and after 12 weeks of the supplementation
Improvement of the dermis structure	Ultrasound (US) images of the dermis will be taken and intensity of the dermis determined. Higher intensity of the dermis US images indicates improvement of the collagen and elastin network.	after 6 and after 12 weeks of the supplementation
An increase of the dermis thickness	Dermis thickness will be measured with ultrasound imaging of the skin.	after 6 and 12 weeks of the supplementation

Collaborators and Investigators

• Sponsor: VIST - Faculty of Applied Sciences
• Collaborators: Nutrition Institute, Slovenia; Valens Int. d.o.o., Slovenija
• Investigators: Study Chair: Janko Zmitek, PhD, VIST - Faculty of Applied Sciences; Study Director: Katja Zmitek, PhD, VIST - Faculty of Applied Sciences; Study Chair: Liljana Mervic, PhD, UL MF; Principal Investigator: Tina Tina Pogačnik, BSc, VIST - Faculty of Applied Sciences

Publications and helpful links

Helpful Links

• Scientific paper with results of the study (Zmitek et al. 2016. The effect of dietary intake of coenzyme Q10 on skin parameters and condition: Results of a randomised, placebo-controlled, double-blind study; Biofactors. 43(1):132-140)

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (ESTIMATE): November 13, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: dry skin; skin rejuvenation; anti-ageing effects; minimal erythema dose; dermis structure; physiological skin condition; wrinkling
• Other Study ID Numbers: Q10 01-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No