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| Name | Class |
|---|---|
| Ministry of Higher Education, Science and Technology, Solvenia | OTHER_GOV |
| European Regional Development Fund | OTHER |
| Slovenian Research Agency | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Placebo group | Placebo Comparator | Placebo - 2 capsules / day containing modified starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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):
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katja Zmitek, PhD | Visoka sola za storitve | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visoka sola za storitve | Ljubljana | 1000 | Slovenia |
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| Placebo | Other | Daily dietary supplementation over 12 weeks with placebo product: dietary supplement - 2 capsules / day, containing only modified starch. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 18 weeks |