The Effect of 24-week Dietary Intake of Food Supplements on Hair: Double Blind, Placebo-controlled, Randomised Three-way Study to Assess Effectiveness of Two Test Products
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hair Thinning
- Sponsor
- VIST - Faculty of Applied Sciences
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily use of novel dietary supplements over 24 weeks is able strengthen and promote growth of hairs, improve their density and thickness and reduce hair loss in adults with self-perceived thinning hair.
Detailed Description
Single centre, randomized, double-blind, placebo-controlled, one-period effectiveness study to evaluate whether the daily use of novel dietary supplements over 24 weeks will strengthen and promote density and quality of hair in adults with self-perceived thinning hair. Study population will be divided in three groups - 32 in active groups and 20 in placebo group. Test group 1 (TG1) will receive investigational product 1 (CPMSM: containing fish collagen, methylsulphonylmethane (MSM), vitamins and zinc), test group 2 (TG2) will receive investigational product 2 (HC+: containing mixture of herbal extracts, B-vitamins and zinc) and the placebo group (PG) will receive placebo product without any of the active ingredients (PL, no active ingredients). Participants will test continuous administration of placebo or investigational products (in the form of syrups) for 24 weeks in order to demonstrate and assess multiple-dose effects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Caucasian volunteers of both sexes; aged 25-60 years at the time of the signature of Informed consent form (ICF).
- •Darker (not blonde or grey) at least 5 cm long on midline.
- •Signed Informed consent form (ICF).
- •Fitzpatrick skin phototypes I-IV.
- •Self-perceived hair thinning - subjects complaining of hair fall and damage.
- •Derived Sinclair Scale score up to
- •In good general health condition.
- •Subjects who are not crash dieting.
- •Willingness to maintain using regular hair care routine regarding hair washing and styling, hair dye / hair colour during the study period.
- •Willingness to refrain from any type of hair treatment like perming, permanent straightening etc. during the study duration.
Exclusion Criteria
- •Pregnancy or breastfeeding or planning pregnancy in near future (in next year).
- •Menopausal female subjects as determined by medical history.
- •Recent initiation or change (\<6 months) of hormones for birth control or hormone replacement therapy in females or other hormonal therapies.
- •Use of treatments for hair growth treatment including minoxidil, finasteride or light therapy within the last 3 months or other medications that are known to cause hair loss or affect hair growth (eg. Cyproterone acetate, Aldactone/spironolactone, 5-alpha-reductase inhibitors, phenytoin) within the last 6 months.
- •Subjects with any clinically significant history of underlying uncontrolled medical illness including thyroid disorders, diabetes mellitus, hypertension, cancer, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
- •Changes in dietary habits and dietary supplementation in the last three months prior to inclusion.
- •Veganism.
- •Regular use of food supplements containing methylsulfonylmethane (MSM), collagen or other protein-based food supplements, Pea sprout extract, Horsetail extract, Ashwagandha root extract, Saw palmetto fruit extract, Nettle leaves extract, Grape seed extract, or vitamin or antioxidant supplements, which will compromise the study, in the last three months prior to inclusion.
- •Subjects having any active scalp or skin disease which may interfere with the study treatment and evaluations.
- •Subjects who have had hair transplant.
Outcomes
Primary Outcomes
Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation
Time Frame: 24-weeks
Significant change of hair density from baseline in test groups, in comparison to placebo group after 24 weeks of dietary supplementation with study products is expected. Hair density will be assessed through trichoscopy using H2H matching procedure. Results will be analysed for whole sample and separately for men and women.
Secondary Outcomes
- Change of scalp sebum from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation(24 weeks)
- Change of hair thickness from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation(24-weeks)
- Change of hair loss from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation(24-weeks)
- Change of terminal hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation(24 weeks)