The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters (Q10-collagen)

The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters: Randomised Double-blind Placebo-controlled Study

Placebo controlled double-blind multi-dose comparative study of the effects of coenzyme Q10 and collagen formulation with improved water-solubility in healthy adults.

One group (test group) will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg) and the other (placebo group) placebo syrup without those active ingredients. Participants will test continuous administration of placebo or investigational product for 12 weeks in order to demonstrate and assess multiple-dose effects on skin condition and signs of skin aging.

Study Overview

• Status: Completed
• Conditions: Wrinkles; Skin Hydration; Trans Epidermal Water Loss (TEWL); Dermis Density; Dermis Thickness
• Intervention / Treatment: Dietary supplement: Test syrup containing CoQ10 and collagen; Dietary supplement: Placebo syrup

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Higher School of Applied Sciences, Institute of Cosmetics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Caucasian female volunteers aged between 40 and 65 years at the time of the signature of Informed consent form (ICF),
• Signed Informed consent form (ICF),
• Fitzpatrick skin phototypes II and III,
• Signs of skin aging,
• In good health condition,
• Willingness to avoid a consumption of any food supplements containing CoQ10 and other antioxidants, collagen or vitamins during the study,
• Willingness to follow all study procedures and keeping a diary during the study (to follow their compliance and palatability).

Exclusion Criteria:

• Pregnancy or breastfeeding,
• Known or suspected allergy to any ingredient of the tested products,
• Changes in dietary habits and dietary supplementation in last three months prior to inclusion,
• Regular use of food supplements containing CoQ10 or other antioxidants, collagen or other protein-based food supplements, vitamin A, vitamin E or biotin in last three months prior to inclusion,
• Veganism,
• Changes in cosmetic facial and body care routine in last month prior to inclusion,
• Diagnosed and uncontrolled/untreated/unregulated disease,
• Any clinically significant history of serious metabolic disease, digestive tract disease, liver disease, kidney disease, haematological disease,
• Acute skin diseases,
• Skin pigmentation disorders,
• Increased cholesterol and use of cholesterol lowering drugs (statins),
• Anticipated sunbathing or solarium visits before or during the study,
• Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy, deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,
• Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound therapy) in last 2 months prior to study entry,
• Mental incapacity that precludes adequate understanding or cooperation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test group; Participants will receive investigational product - Test syrup containing CoQ10 and collagen (daily dose 10 mL: fish collagen (Peptan®): 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg).	Dietary supplement: Test syrup containing CoQ10 and collagen; Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks.
Placebo Comparator: Placebo group; Placebo group participants will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.	Dietary supplement: Placebo syrup; Placebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement	Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity	For assessments of skin viscoelasticity measurements will be performed. Significant change of skin viscoeasticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.	12 weeks
Influence of the investigational product in relation to placebo product on skin hydration	Assessment of the effects of the investigational product on skin hydration after 12 weeks of dietary supplementation. Skin hydration measurements will be performed using conductance principle.	12 weeks
Influence of the investigational product in relation to placebo product on TEWL	Assessment of the effects of investigational product on transepidermal water loss after 12 weeks of dietary supplementation. TEWL measurements will be performed using open chambre principle.	12 weeks
Influence of investigational product in relation to placebo product on dermis thickness	Significant change of dermis thickness from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed using ultrasonography.	12 weeks
Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements	Assessment of the effects of investigational product on facial wrinkles after 12 weeks of dietary supplementation will be done using wrinkle area fraction measurements.	12 weeks

Collaborators and Investigators

• Sponsor: Higher School of Applied Sciences (VIST)
• Collaborators: European Regional Development Fund; Valens Int. d.o.o., Slovenija; Ministry of Education, Science and Sport, Republic of Slovenia
• Investigators: Study Director: Katja Žmitek, PhD, Head of Reasearch Group

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): February 19, 2019
• Study Completion (Actual): July 10, 2019

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Coenzyme Q10
• Other Study ID Numbers: VIST F4F Q10-collagen 01-2018

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