Clinical trial NCT03811756: The Effect of 12-week Dietary Intake of Syrup Containing CoQ10 and Collagen on Dermis Density and Other Skin Parameters
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermis Density
Trans Epidermal Water Loss (TEWL)
Skin Hydration
Wrinkles
Dermis Thickness
Lead sponsor: VIST - Faculty of Applied Sciences
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
name: Valens Int. d.o.o., Slovenija
name: Ministry of Education, Science and Sport, Republic of Slovenia
First posted: 2019-01-22
Enrollment: 34
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
timeFrame: 12 weeks
Secondary outcomes:
measure: Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
timeFrame: 12 weeks
measure: Influence of the investigational product in relation to placebo product on skin hydration
timeFrame: 12 weeks
measure: Influence of the investigational product in relation to placebo product on TEWL
timeFrame: 12 weeks
measure: Influence of investigational product in relation to placebo product on dermis thickness
timeFrame: 12 weeks
measure: Influence of investigational product in relation to placebo product on wrinkles will be assessed using wrinkle area fraction measurements
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Higher School of Applied Sciences, Institute of Cosmetics
Study officials:
affiliation: Head of Reasearch Group
name: Katja Žmitek, PhD
role: STUDY_DIRECTOR
References: