Study of the Effect of 12-week Dietary Supplementation With a Multicomponent Nutritional Supplement on Nails and Skin

NCT05100680 | Completed DMC

• 1 other identifier: VIST F4F MULTIK 01-2019
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, randomized, placebo-controlled efficacy study in one period will include 34 participants divided into two groups. One group will receive a test product (n = 22; test group; multicomponent dietary supplement including MSM and several vitamins and minerals); the other group received placebo capsules (n = 12; placebo group; only modified starch). Volunteers will take two capsules / day orally continuously daily for 12 weeks to assess the effect of these substances on nail growth and condition and skin.

Conditions

Nail Damage

Outcome Measures

Primary Outcomes (1)

• Change of frequency of nail fracture

  Significant change of frequency of nail fracture from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Frequency (number/day) of nail fracture will be assessed through diary of nail condition. For baseline nail fracture daily diary log will be kept for 4-6 weeks before dietary supplementation and for evaluation of treatment effects diary log will be kept from week 9 through 12 of the intervention.

  18 weeks

Secondary Outcomes (7)

• Change of the PGA score for assessment of the signs of brittle nails

  12 weeks

• Change of the PGIA score for assessment of the signs of brittle nails

  12 weeks

• Change of the nail growth rate

  18 weeks

• Change in self-assessment of nail condition

  12 weeks

• Change in expert assessment of nail condition

  12 weeks

Study Arms (2)

Multicomp group

ACTIVE COMPARATOR

Food supplement - 2 capsules / day containing together: 20 mg coenzyme Q10,500 mg methyl sulfonyl methane (MSM), 100 mg L-proline, 10 mg L-cysteine (as HCl monohydrate), 2 mg thiamine , 2.4 mg riboflavin, 19 mg niacin, 8.5 mg pantothenic acid, 2.3 mg vitamin B6, 0.15 mg, biotin, 0.0125 mg vitamin B12, 80 mg vitamin C, 5.5 mg vitamin A , 22 mg vitamin E, 10 mg zinc, 0.07 mg selenium, 1.1 mg copper.

Other: Multicomp

Placebo group

PLACEBO COMPARATOR

Placebo - 2 capsules / day containing modified starch

Other: Placebo

Interventions

Multicomp OTHER

Daily dietary supplementation over 12 weeks with test product: food supplement - 2 capsules / day containing together: 20 mg coenzyme Q10,500 mg methyl sulfonyl methane (MSM), 100 mg L-proline, 10 mg L-cysteine (as HCl monohydrate), 2 mg thiamine , 2.4 mg riboflavin, 19 mg niacin, 8.5 mg pantothenic acid, 2.3 mg vitamin B6, 0.15 mg, biotin, 0.0125 mg vitamin B12, 80 mg vitamin C, 5.5 mg vitamin A , 22 mg vitamin E, 10 mg zinc, 0.07 mg selenium, 1.1 mg copper.

Multicomp group

Placebo OTHER

Daily dietary supplementation over 12 weeks with placebo product: dietary supplement - 2 capsules / day, containing only modified starch.

Placebo group

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women and men who are diagnosed at the introductory term with any of the following signs of brittle nails on at least one of the assessed nails (preferably at least two signs):
• rough surface of the nail plate or presence of keratin granulation (trachyonychia)
• lamellar stratification - horizontal layering / peeling (onychoschizia)
• longitudinal stratification or splitting of the distal edge, rupture (onychorrhexis)
• generally healthy
• willingness to participate in research
• signed statement of conscious and free consent to research - informed consent
• willingness not to use any dietary supplements with the active substances contained in the test product (CoQ10, biotin, niacin, vitamin C, β-carotene, vitamin E, zinc, selenium, copper, MSM, L-cysteine, L- proline), other than those to be allocated by researchers
• willingness to follow all research procedures, including participation in all study visits and keeping a diary during the testing of preparations

You may not qualify if:

• Allergy to or suspicion of any ingredient in the test products
• menopause
• pregnancy, lactation
• in the past, surgery on the index finger / middle finger / ring finger of the right hand
• Disorders and deformities of the index finger, middle finger and ring finger of the right hand due to a malformation of the underlying bone, which would interfere with the evaluation of photographs or changes in the nails
• the presence of raised nails from the nail bed (onycholysis) on the index finger, middle finger and ring finger of the right hand
• special eating habits used by a small part of the population (veganism, LCHF, calorie-restricted diets)
• diets prescribed by the medical profession
• uncontrolled metabolic and endocrine diseases
• Chronic dermatoses e.g. psoriasis, ichthyosis, various types of dermatitis, lichen planus, alopecia areata, scleroderma
• systemic diseases such as SLE, DLE, diabetes, neuropathy, peripheral artery disease
• have a known or suspected genetic condition that affects the nails (eg Darier's disease, nail patella syndrome, tuberculous sclerosis)
• the presence of anemia
• mental eating disorders
• mental incapacity that prevents proper understanding or cooperation

Sponsors & Collaborators

• VIST - Faculty of Applied Sciences: lead
• Ministry of Education, Science and Sport of Republic of Slovenia: collaborator
• European Regional Development Fund: collaborator
• Slovenian Research Agency: collaborator

Study Sites (1)

Visoka sola za storitve

Ljubljana, 1000, Slovenia

Location

Study Officials

• Katja Zmitek, PhD

  Visoka sola za storitve

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: October 29, 2021
• Study Start: November 25, 2019
• Primary Completion: May 30, 2020
• Study Completion: September 1, 2020
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)