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

NCT06174441 | Completed

• 1 other identifier: VIST TO-HAIR 01-2023
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Hair Thinning; Hair Loss

Outcome Measures

Primary Outcomes (1)

• Change of hair density from baseline in all test groups in comparison to placebo group after 24 weeks of dietary supplementation

  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.

  24-weeks

Secondary Outcomes (4)

• 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

Study Arms (3)

Test group 1 (CPMSM)

ACTIVE COMPARATOR

Investigational product 1: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg.

Dietary Supplement: Investigational product 1 (CPMSM)

Test group 2 (HC+)

ACTIVE COMPARATOR

Investigational product 2: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg. Intervention: Dietary Supplement: Placebo Placebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients).

Dietary Supplement: Investigational product 2 (HC+)

Placebo group

PLACEBO COMPARATOR

placebo product without any of the active ingredients, daily dose 25 mL: no active ingredients.

Dietary Supplement: Placebo

Interventions

Investigational product 1 (CPMSM) DIETARY_SUPPLEMENT

Test group 1 will receive investigational product 1 (CPMSM: daily dose 25 mL contains: Hydrolyzed fish collagen 5 g, methylsulphonylmethane (MSM) 1,5 g, Biotin 150 μg, Vitamin B6 1,6 mg, Zinc 2 mg, Vitamin C 120 mg).

Test group 1 (CPMSM)

Investigational product 2 (HC+) DIETARY_SUPPLEMENT

Test group 2 (TG2) will receive investigational product 2 (HC+: daily dose 25 mL contains: Niacin 16 mg, Pantothenic acid 6 mg, Biotin 500 μg, Vitamin B6 1,4 mg, Folic acid 200 μg, Zinc 2 mg, Pea sprout extract 100 mg, Horsetail aerial parts extract 70 mg, Ashwagandha root extract 40 mg, Saw palmetto fruit extract 40 mg, Nettle leaves extract 30 mg, Grape seed extract 10 mg).

Test group 2 (HC+)

Placebo DIETARY_SUPPLEMENT

Placebo group (PG) will receive placebo product without any of the active ingredients (PL, daily dose 25 mL: no active ingredients).

Placebo group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 3.
• 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.
• 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 oral medications or supplement for hair growth during the study.
• BMI \< 35
• Willingness to avoid a consumption of any other food supplements containing methylsulfonylmethane (MSM), antioxidants, 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, 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 (to follow their compliance and palatability).

You may not qualify if:

• 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.
• Veganism.
• Subjects having any active scalp or skin disease which may interfere with the study treatment 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 last year.
• Subjects who have experienced a known stressful event within the last 6 months such as death in family, miscarriage etc.
• Known history or recent blood work indicating iron deficiency, bleeding disorders or platelet dysfunction syndrome.
• Smokers with usage \> 20 cigarettes/day.
• Mental incapacity that precludes adequate understanding or cooperation.

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead
• Slovenian Research and Innovation Agency: collaborator
• Tosla d.o.o.: collaborator

Study Sites (1)

VIST - Faculty of Applied Sciences, Institute of Cosmetics

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Katja Žmitek, PhD

  Head of research 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: December 8, 2023
• First Posted: December 18, 2023
• Study Start: January 8, 2024
• Primary Completion: July 18, 2024
• Study Completion: October 25, 2024
• Last Updated: October 29, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)