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

NCT ID: NCT02604641

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-05-31

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.

Conditions

Wrinkles; Ageing; Photoprotection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo group

0 mg CoQ10 daily

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.

Quvital LD group

50 mg CoQ10 daily

Group Type: ACTIVE_COMPARATOR

Quvital LD group

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.

Quvital HD group

150 mg CoQ10 daily

Group Type: ACTIVE_COMPARATOR

Quvital HD group

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.

Interventions

Placebo group

Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Quvital LD group

Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Quvital HD group

Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Valens Int. d.o.o., Slovenija

INDUSTRY

Sponsor Role: collaborator

Institute of Nutrition, Slovenia (Nutris)

OTHER

Sponsor Role: collaborator

VIST - Faculty of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janko Zmitek, PhD

Role: STUDY_CHAIR

VIST - Faculty of Applied Sciences

Katja Zmitek, PhD

Role: STUDY_DIRECTOR

VIST - Faculty of Applied Sciences

Liljana Mervic, PhD

Role: STUDY_CHAIR

UL MF

Tina Tina Pogačnik, BSc

Role: PRINCIPAL_INVESTIGATOR

VIST - Faculty of Applied Sciences

Related Links

http://onlinelibrary.wiley.com/doi/10.1002/biof.1316/abstract

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)

Other Identifiers

Q10 01-2014

Identifier Type: -

Identifier Source: org_study_id