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

NCT03811756 | Completed

• 1 other identifier: VIST F4F Q10-collagen 01-2018
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  12 weeks

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

  12 weeks

• Influence of the investigational product in relation to placebo product on TEWL

  12 weeks

• Influence of investigational product in relation to placebo product on dermis thickness

  12 weeks

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

  12 weeks

Study Arms (2)

Test group

ACTIVE COMPARATOR

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

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.

Test group

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.

Placebo group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Pregnancy or breastfeeding,
• Known or suspected allergy to any ingredient of the tested products,
• Veganism,
• 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.

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead
• European Regional Development Fund: collaborator
• Valens Int. d.o.o., Slovenija: collaborator
• Ministry of Education, Science and Sport, Republic of Slovenia: collaborator

Study Sites (1)

Higher School of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Collagen

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Katja Žmitek, PhD

  Head of Reasearch Group

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: October 15, 2018
• Primary Completion: February 19, 2019
• Study Completion: July 10, 2019
• Last Updated: October 14, 2021

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)