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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
34
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.
Daily dietary supplementation over 12 weeks with placebo product: dietary supplement - 2 capsules / day, containing only modified starch.
Visoka sola za storitve
Ljubljana, Slovenia
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.
Time frame: 18 weeks
Change of the PGA score for assessment of the signs of brittle nails
Change of the signs of brittle nails from the initial state according to PGA score (physical global assessment score) after 12 weeks of supplementation with a test supplement compared to placebo. PGA scale of expression of changes on the nail: 0: no noticeable changes, 1: mild change, 2: mild / moderate change, 3: moderate change, 4: moderate / strong change, 5: strong change.
Time frame: 12 weeks
Change of the PGIA score for assessment of the signs of brittle nails
Change of the signs of brittle nails from the initial state according to PGIA score (physical global improvement assessment score) Improvement of brittle nail symptoms from baseline after 12 weeks of supplementation with a test supplement compared to a placebo product rated with a PGIA (physical global improvement assessment score): -1: worsening, 0: unchanged, 1: mild improvement, 2: moderate marked improvement, 3: strong improvement.
Time frame: 12 weeks
Change of the nail growth rate
Change in nail growth rate from baseline after 12 weeks of supplementation with a test supplement compared to placebo. For baseline nail growth rate nail will be market at week 0 and growth measured after 4-6 weeks, before start of the supplementation. For growth rate after supplementation nail will be market at week 8 and growth measured after 4 weeks of further supplementation.
Time frame: 18 weeks
Change in self-assessment of nail condition
Change in self-assessment of nail condition from baseline will be done at baseline and after 12 weeks of supplementation with a test supplement compared to a placebo product rated on a scale: 1 = very poor condition, 2 = poor condition, 3 = neither poor nor good condition, 4 = good condition, 5 = very good condition.
Time frame: 12 weeks
Change in expert assessment of nail condition
Change in expert assessment of nail condition from baseline will be done at baseline and after 12 weeks of supplementation with a test supplement compared to a placebo product rated on a scale: 1 = very poor condition, 2 = poor condition, 3 = neither poor nor good condition, 4 = good condition, 5 = very good condition.
Time frame: 12 weeks
Change of frequency in lamellar onychoschizia
Significant change of frequency of lamellar onychoschizia from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Frequency of lamellar onychoschizia will be assessed through diary of nail condition. For baseline lamellar onychoschizia 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.
Time frame: 18 weeks
Change of frequency of onychorrhexis
Significant change of frequency of onychorrhexis from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Frequency of onychorrhexis will be assessed through diary of nail condition. For baseline onychorrhexis 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.
Time frame: 18 weeks
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