Clinical trial NCT05100680: Study of the Effect of 12-week Dietary Supplementation With a Multicomponent Nutritional Supplement on Nails and Skin
Official title: Study of the Effect of 12-week Dietary Supplementation With a Multicomponent Nutritional Supplement on Nails and Skin: a Randomized, Double-blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nail Damage
Lead sponsor: VIST - Faculty of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Science and Sport of Republic of Slovenia
name: European Regional Development Fund
name: Slovenian Research Agency
First posted: 2021-10-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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):

  * 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

Exclusion Criteria:

* 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
* supplementing the diet with dietary supplements containing CoQ10, biotin and other ingredients of the test product in the last three months before inclusion
* 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
* sawing the surface of the nail plate or. polishing it in the last 6 months before inclusion and during the study
* any type of manicure involving gelling, artificial nails in the last 6 months before inclusion and during the study
* any type of classic manicure in the last month before inclusion and during the study
* change in the nail and hand care routine in the last month before inclusion and during the study
* change of dietary habits or dietary supplementation in the last 3 months before inclusion and during the study
* infections of the hands and nails on the hands (fungal, bacterial, viral)
* biting fingernails or cuticles
* mechanical irritation and damage to the nails,
* repeated prolonged exposure of the hands to water or repeated use of hand sanitizers,
* use of antimetabolites, retinoids, statins, antiretroviral drugs, fungicides in the last 3 months before inclusion and during the study
* changes in the use of hormonal preparations in the last 6 months before inclusion and during the study

Primary outcomes:
measure: Change of frequency of nail fracture
timeFrame: 18 weeks
Secondary outcomes:
measure: Change of the PGA score for assessment of the signs of brittle nails
timeFrame: 12 weeks
measure: Change of the PGIA score for assessment of the signs of brittle nails
timeFrame: 12 weeks
measure: Change of the nail growth rate
timeFrame: 18 weeks
measure: Change in self-assessment of nail condition
timeFrame: 12 weeks
measure: Change in expert assessment of nail condition
timeFrame: 12 weeks
measure: Change of frequency in lamellar onychoschizia
timeFrame: 18 weeks
measure: Change of frequency of onychorrhexis
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Visoka sola za storitve
Study officials:
affiliation: Visoka sola za storitve
name: Katja Zmitek, PhD
role: STUDY_DIRECTOR
References: