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

Sponsor
Higher School of Applied Sciences (VIST) (Other)
Overall Status
Completed
CT.gov ID
NCT02604641
Collaborator
Valens Int. d.o.o., Slovenija (Industry), Nutrition Institute, Slovenia (Other)
33
3
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Placebo group
  • Dietary Supplement: Quvital LD group
  • Dietary Supplement: Quvital HD group
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin: Randomised, Double-blind, Placebo-controlled Pilot Study
Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Improvement of photoprotective function of the skin [after 12 weeks of the supplementation]

    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.

Secondary Outcome Measures

  1. Reduction of the area of the periorbital facial wrinkles [after 6 and after 12 weeks of the supplementation]

    Area of selected periorbital wrinkles will be quantitatively assessed using CSI programme.

  2. Reduction of the volume of the periorbital facial wrinkles [after 6 and after 12 weeks of the supplementation]

    Volume of selected periorbital wrinkles will be quantitatively assessed using CSI programme.

  3. Reduction of wrinkles at different face areas [after 6 and after 12 weeks of the supplementation]

    Expert assessment of wrinkles at different face areas (periorbital, frontal, glabelar, nasolabial areas etc.) will be done according to Lemperle Wrinkle assessment scale.

  4. Improvement of the dermis structure [after 6 and after 12 weeks of the supplementation]

    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.

  5. An increase of the dermis thickness [after 6 and 12 weeks of the supplementation]

    Dermis thickness will be measured with ultrasound imaging of the skin.

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Study Chair: Janko Zmitek, PhD, Higher School of Applied Sciences (VIST)
  • Study Director: Katja Zmitek, PhD, Higher School of Applied Sciences (VIST)
  • Study Chair: Liljana Mervic, PhD, UL MF
  • Principal Investigator: Tina Tina Pogačnik, BSc, Higher School of Applied Sciences (VIST)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Higher School of Applied Sciences (VIST)
ClinicalTrials.gov Identifier:
NCT02604641
Other Study ID Numbers:
  • Q10 01-2014
First Posted:
Nov 13, 2015
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Higher School of Applied Sciences (VIST)

Study Results

No Results Posted as of Oct 8, 2021