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Completed

NCT Number: NCT03811756

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

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.

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Key information

Conditions

Dermis Density Dermis Thickness Skin Hydration Trans Epidermal Water Loss (TEWL) Wrinkles

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test syrup containing CoQ10 and collagen

Dietary Supplement

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 syrup

Dietary Supplement

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.

Primary outcomes

  1. Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity

    Time frame: 12 weeks

    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.

  2. Influence of the investigational product in relation to placebo product on skin hydration

    Time frame: 12 weeks

    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.

  3. Influence of the investigational product in relation to placebo product on TEWL

    Time frame: 12 weeks

    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.

  4. Influence of investigational product in relation to placebo product on dermis thickness

    Time frame: 12 weeks

    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.

  5. Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements

    Time frame: 12 weeks

    Assessment of the effects of investigational product on facial wrinkles after 12 weeks of dietary supplementation will be done using wrinkle area fraction measurements.

Sponsors and collaborators

Lead sponsor

VIST - Faculty of Applied Sciences

Other

Collaborators

  • European Regional Development Fund
  • Ministry of Higher Education, Science and Technology, Solvenia
  • Valens Int. d.o.o., Slovenija

Registry information

Official study title

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

Acronym: Q10-collagen

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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