The Effect of 24-week Dietary Intake of Food Supplements on Hair

Last updated: October 25, 2024
Sponsor: VIST - Faculty of Applied Sciences
Overall Status: Completed

Phase

N/A

Condition

Alopecia

Hair Loss

Treatment

Placebo

Investigational product 1 (CPMSM)

Investigational product 2 (HC+)

Clinical Study ID

NCT06174441
VIST TO-HAIR 01-2023
  • Ages 21-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Caucasian volunteers of both sexes; aged 25-60 years at the time of the signature ofInformed 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 3.

  • In good general health condition.

  • Subjects who are not crash dieting.

  • Willingness to maintain using regular hair care routine regarding hair washing andstyling, hair dye / hair colour during the study period.

  • Willingness to refrain from any type of hair treatment like perming, permanentstraightening etc. during the study duration.

  • Willingness to not substantially change their lifestyle, current diet, medications,or exercise routines for the duration of the study.

  • Willingness to refrain from any other topical treatment/hair spa and oralmedications or supplement for hair growth during the study.

  • BMI < 35

  • Willingness to avoid a consumption of any other food supplements containingmethylsulfonylmethane (MSM), antioxidants, collagen or other protein-based foodsupplements, Pea sprout extract, Horsetail extract, Ashwagandha root extract, Sawpalmetto fruit extract, Nettle leaves extract, Grape seed extract, biotin, zinc,niacin, pantothenic acid, vitamin B6, folic acid during the study.

  • Willingness to follow all study procedures and keeping a diary during the study (tofollow their compliance and palatability).

  • Willingness not to begin or change any estrogen or progesterone or other hormonaltherapies.

  • Willingness of subjects who have color treated hair to have the color treatmentperformed at the same time interval prior to each visit.

  • No known or suspected allergy to any ingredient of the tested products asestablished by medical history.

Exclusion

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 hormonereplacement therapy in females or other hormonal therapies.

  • Use of treatments for hair growth treatment including minoxidil, finasteride orlight therapy within the last 3 months or other medications that are known to causehair 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 medicalillness including thyroid disorders, diabetes mellitus, hypertension, cancer, HIV,hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or anyother serious medical illness.

  • Changes in dietary habits and dietary supplementation in the last three months priorto inclusion.

  • Veganism.

  • Regular use of food supplements containing methylsulfonylmethane (MSM), collagen orother protein-based food supplements, Pea sprout extract, Horsetail extract,Ashwagandha root extract, Saw palmetto fruit extract, Nettle leaves extract, Grapeseed extract, or vitamin or antioxidant supplements, which will compromise thestudy, in the last three months prior to inclusion.

  • Subjects having any active scalp or skin disease which may interfere with the studytreatment and evaluations.

  • Subjects who have had hair transplant.

  • Subjects undergoing any chemical hair salon treatment-straightening / perming.

  • Subjects participating in other similar cosmetic or therapeutic trial within lastyear.

  • Subjects who have experienced a known stressful event within the last 6 months suchas death in family, miscarriage etc.

  • Known history or recent blood work indicating iron deficiency, bleeding disorders orplatelet dysfunction syndrome.

  • Smokers with usage > 20 cigarettes/day.

  • Changes in hair care routine in the last month prior to inclusion,

  • Mental incapacity that precludes adequate understanding or cooperation.

Study Design

Total Participants: 89
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
October 25, 2024

Study 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.

Connect with a study center

  • VIST - Faculty of Applied Sciences, Institute of Cosmetics

    Ljubljana, 1000
    Slovenia

    Site Not Available

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