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

Wrinkles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604641
• Other study ID #: Q10 01-2014
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 2015

Study information

• Verified date: October 2021
• Source: Higher School of Applied Sciences (VIST)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ageing
• Photoprotection
• Wrinkles

Intervention

Dietary Supplement:
• Placebo group
Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.
• Quvital LD group
Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.
• Quvital HD group
Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Higher School of Applied Sciences (VIST)	Nutrition Institute, Slovenia, Valens Int. d.o.o., Slovenija

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External 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)