Effects of Dietary Supplements on Nail and Hair Health

Официальное название

Effects of the Dietary Supplements, Congaplex® and Immuplex®, on Age-Related Changes in Fingernail and Hair Health

Обзор

This is a research study conducted by Standard Process, Inc. and the University of North Carolina and Chapel Hill Nutrition Research Institute, which aims to evaluate the effectiveness of nutritional supplementation in improving the health of fingernails and hair.

Подробное описание

This study is a prospective, randomized, double-blind, controlled clinical trial focused on evaluating the effects of two nutritional supplements, Congaplex® (test product 1, TP1) and Immuplex® (TP2), versus an active control (AC) product, Gastro-Fiber®, on the health of fingernails and hair. The study will include a total of 90 participants across 3 arms and use a parallel-group design: 30 participants in TP1 group, 30 participants in TP2 group, and 30 participants in the AC group. The participants and the research personnel will be blind to the treatment. The AC product contains powder in capsules that have an identical size and similar appearance to Congaplex® and Immuplex®.

Вмешательства

• Пищевая добавка Immune Health (Congaplex)
  Supplement related to nail, hair, and immune health
• Пищевая добавка Active Control (Gastro-Fiber)
  Supplement not related to immune, hair, or nail health
• Пищевая добавка Immune Health (Immuplex)
  Supplement related to nail, hair, and immune health

Первичные конечные точки

• Determine the effects of test products (TP1/2) versus active control (AC) on numbers and severity of longitudinal (vertical) nail ridges [Срок оценки: 6 months]
• Determine the effects of TP1/2 versus AC on nail biostructure and biochemical composition after 6 months of supplementation [Срок оценки: 6 months]

Вторичные конечные точки (3)

• Determine the effects of test products TP1/2 versus AC on density, thickness and pigmentation of hair [Срок оценки: 6 months]
• Determine the effects of TP1/2 versus AC on near vision (visual accommodation) [Срок оценки: 6 months]
• Determine the effects of TP1/2 versus AC on the scores of general health questionnaire [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Healthy female and male adults who are 18 to 75 years of age (inclusive)
• Display longitudinal (vertical) nail ridges in the absence of other nail abnormalities
• No cosmetic nail treatments that would mask the natural appearance of the nail plate in the past 6 months (i.e., manicure procedures that smooth the nail surface, nail polish)
• In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product
• Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:

• use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contra-ceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or
• use for at least 1 month prior to the first dose of study product: double-barrier method, non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual inter-course that may result in pregnancy; or
• vasectomy of partner at least 6 months prior to the first dose of study product Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that may result in pregnancy is also acceptable.
• Agree to refrain from treatments listed in Section 8.3 in the defined timeframe
• Have maintained stable dietary habits (including supplement intake), exercise habits and lifestyle for the last 3 months prior to screening and agree to maintain dietary and exercise habits and lifestyle throughout the study
• Willing and able to agree to the requirements and restrictions of this study, be willing to give volun-tary consent, be able to understand and read the questionnaire, and carry out all study-related pro-cedures

Критерии исключения

• Individuals who are lactating, pregnant or planning to become pregnant during the study as con-firmed at the baseline visit (Visit 2)
• Individuals who have applied cosmetic/topical treatments to fingernails in the past 6 months (i.e., manicures with nail plate filing, nail polish)
• Individuals who display nail abnormalities indicative of a health condition affecting nail appearance or have been diagnosed with a disease affecting nails (i.e., thickening, discoloration, horizontal nail ridges \[Beau's lines\])
• Individuals with active nail biting (onychophagia) or other behaviors that may affect nail integrity
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
• Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit
• Individuals opposed to consuming animal products
• Have a history of uncontrolled hypertension (140/90 or greater mmHg), kidney dysfunction or dis-ease (dialysis or renal failure), hepatic impairment or disease
• Individuals who lack the capacity to provide informed consent, as determined by the study team based on cognitive impairment, altered mental status, or inability to understand the study and make an informed decision

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Hays RD, Morales LS. The RAND-36 measure of health-related quality of life. Ann Med. 2001 Jul;33(5):350-7. doi: 10.3109/07853890109002089. PMID 11491194
• Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6. PMID 7091289
• Kim DY, Ahn H, Lee S, Jun I, Seo KY, Kim SY, Kim TI. Efficacy of a new refractive multifocal contact lens for presbyopia. Sci Rep. 2024 Apr 17;14(1):8878. doi: 10.1038/s41598-024-55918-5. PMID 38632261
• Ozeren E. Is C-reactive protein-albumin ratio or neutrophil-lymphocyte ratio a better indicator to predict in-hospital mortality in traumatic brain injury? Ulus Travma Acil Cerrahi Derg. 2022 Oct;28(10):1482-1487. doi: 10.14744/tjtes.2022.00794. PMID 36169474
• Baccaglini L, Theriaque DW, Shuster JJ, Serrano G, Lalla RV. Validation of anamnestic diagnostic criteria for recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Apr;42(4):290-4. doi: 10.1111/jop.12015. Epub 2012 Oct 27. PMID 23106421
• Karincaoglu Y, Batcioglu K, Erdem T, Esrefoglu M, Genc M. The levels of plasma and salivary antioxidants in the patient with recurrent aphthous stomatitis. J Oral Pathol Med. 2005 Jan;34(1):7-12. doi: 10.1111/j.1600-0714.2004.00253.x. PMID 15610400
• Arikan S, Durusoy C, Akalin N, Haberal A, Seckin D. Oxidant/antioxidant status in recurrent aphthous stomatitis. Oral Dis. 2009 Oct;15(7):512-5. doi: 10.1111/j.1601-0825.2009.01580.x. PMID 19761497
• Edgar NR, Saleh D, Miller RA. Recurrent Aphthous Stomatitis: A Review. J Clin Aesthet Dermatol. 2017 Mar;10(3):26-36. Epub 2017 Mar 1. PMID 28360966

Идентификаторы

NCT: NCT07373574 · SPD-01 · Pro00088817

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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