Effects of Dietary Supplements on Nail and Hair Health

NCT07373574 | Not Yet Recruiting

• 2 other identifiers: SPD-01Pro00088817
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nutrient Intake; Nutrient Intake Inadequacy

Keywords

Nutrition; Hair Health; Nail Health

Outcome Measures

Primary Outcomes (2)

• Determine the effects of test products (TP1/2) versus active control (AC) on numbers and severity of longitudinal (vertical) nail ridges

  Changes in scores of vertical nail ridge numbers and severity according to Nail Score Chart will be determined at baseline (scores and pictures at V2), at 3 months (pictures only at V3) and 6 months (scores and pictures at V4) of supplementation

  6 months

• Determine the effects of TP1/2 versus AC on nail biostructure and biochemical composition after 6 months of supplementation

  Changes in Raman spectra of fingernail tissue at baseline (V2) compared to month 6 (V4) of supplementation

  6 months

Secondary Outcomes (3)

• Determine the effects of test products TP1/2 versus AC on density, thickness and pigmentation of hair

  6 months

• Determine the effects of TP1/2 versus AC on near vision (visual accommodation)

  6 months

• Determine the effects of TP1/2 versus AC on the scores of general health questionnaire

  6 months

Other Outcomes (96)

• Assess the safety and tolerability of TP1/2 and AC in healthy participants

  6 months

• Anthropometrics

  6 months

• Vitals

  6 months

Study Arms (3)

Congaplex

EXPERIMENTAL

TP1: 6 capsules/day

Dietary Supplement: Immune Health (Congaplex)

Immuplex

EXPERIMENTAL

TP2: 6 capsules/day

Dietary Supplement: Immune Health (Immuplex)

Gastro-Fiber

ACTIVE COMPARATOR

AC: 6 capsules/day

Dietary Supplement: Active Control (Gastro-Fiber)

Interventions

Immune Health (Congaplex) DIETARY_SUPPLEMENT

Supplement related to nail, hair, and immune health

Congaplex

Active Control (Gastro-Fiber) DIETARY_SUPPLEMENT

Supplement not related to immune, hair, or nail health

Gastro-Fiber

Immune Health (Immuplex) DIETARY_SUPPLEMENT

Supplement related to nail, hair, and immune health

Immuplex

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Standard Process Inc.: lead
• UNC Nutrition Research Institute: collaborator

Related Publications (28)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Tappuni AR, Kovacevic T, Shirlaw PJ, Challacombe SJ. Clinical assessment of disease severity in recurrent aphthous stomatitis. J Oral Pathol Med. 2013 Sep;42(8):635-41. doi: 10.1111/jop.12059. Epub 2013 Mar 19.

  PMID: 23509958 BACKGROUND

• Sanchez-Bernal J, Conejero C, Conejero R. Recurrent Aphthous Stomatitis. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):471-480. doi: 10.1016/j.ad.2019.09.004. Epub 2020 May 22. English, Spanish.

  PMID: 32451064 BACKGROUND

• Chang H, Johnson E, Khoo C, Wang W, Gu L. Cranberry Juice Polyphenols Inhibited the Formation of Advanced Glycation End Products in Collagens, Inhibited Advanced Glycation End Product-Induced Collagen Crosslinking, and Cleaved the Formed Crosslinks. J Agric Food Chem. 2022 Dec 14;70(49):15560-15569. doi: 10.1021/acs.jafc.2c06502. Epub 2022 Dec 1.

  PMID: 36455288 BACKGROUND

• Haus JM, Carrithers JA, Trappe SW, Trappe TA. Collagen, cross-linking, and advanced glycation end products in aging human skeletal muscle. J Appl Physiol (1985). 2007 Dec;103(6):2068-76. doi: 10.1152/japplphysiol.00670.2007. Epub 2007 Sep 27.

  PMID: 17901242 BACKGROUND

• Aggarwala KRG. Ocular Accommodation, Intraocular Pressure, Development of Myopia and Glaucoma: Role of Ciliary Muscle, Choroid and Metabolism. Med Hypothesis Discov Innov Ophthalmol. 2020;9(1):66-70. Epub 2020 Jan 5.

  PMID: 31976346 BACKGROUND

• Kuzuhara A, Fujiwara N, Hori T. Analysis of internal structure changes in black human hair keratin fibers with aging using Raman spectroscopy. Biopolymers. 2007 Oct 5-15;87(2-3):134-40. doi: 10.1002/bip.20805.

  PMID: 17626296 BACKGROUND

• Brito ALB, Bruggen C, Ildiz GO, Fausto R. Investigation of menopause-induced changes on hair by Raman spectroscopy and chemometrics. Spectrochim Acta A Mol Biomol Spectrosc. 2022 Jul 5;275:121175. doi: 10.1016/j.saa.2022.121175. Epub 2022 Mar 21.

  PMID: 35344858 BACKGROUND

• Jain N, Doshi B, Khopkar U. Trichoscopy in alopecias: diagnosis simplified. Int J Trichology. 2013 Oct;5(4):170-8. doi: 10.4103/0974-7753.130385.

  PMID: 24778525 BACKGROUND

• Park AM, Khan S, Rawnsley J. Hair Biology: Growth and Pigmentation. Facial Plast Surg Clin North Am. 2018 Nov;26(4):415-424. doi: 10.1016/j.fsc.2018.06.003. Epub 2018 Aug 16.

  PMID: 30213423 BACKGROUND

• Gniadecka M, Faurskov Nielsen O, Christensen DH, Wulf HC. Structure of water, proteins, and lipids in intact human skin, hair, and nail. J Invest Dermatol. 1998 Apr;110(4):393-8. doi: 10.1046/j.1523-1747.1998.00146.x.

  PMID: 9540981 BACKGROUND

• Fawcett RS, Linford S, Stulberg DL. Nail abnormalities: clues to systemic disease. Am Fam Physician. 2004 Mar 15;69(6):1417-24.

  PMID: 15053406 BACKGROUND

• Yin J, Ibrahim S, Petersen F, Yu X. Autoimmunomic Signatures of Aging and Age-Related Neurodegenerative Diseases Are Associated With Brain Function and Ribosomal Proteins. Front Aging Neurosci. 2021 May 28;13:679688. doi: 10.3389/fnagi.2021.679688. eCollection 2021.

  PMID: 34122052 BACKGROUND

• Hanlon PR, Robbins MG, Scholl C, Barnes DM. Aqueous extracts from dietary supplements influence the production of inflammatory cytokines in immortalized and primary T lymphocytes. BMC Complement Altern Med. 2009 Dec 14;9:51. doi: 10.1186/1472-6882-9-51.

  PMID: 20003431 BACKGROUND

• Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019 Apr 23;321(16):1610-1620. doi: 10.1001/jama.2019.3087.

  PMID: 31012939 BACKGROUND

• Blumberg J. Nutritional needs of seniors. J Am Coll Nutr. 1997 Dec;16(6):517-23.

  PMID: 9430078 BACKGROUND

• Ramaa CS, Shirode AR, Mundada AS, Kadam VJ. Nutraceuticals--an emerging era in the treatment and prevention of cardiovascular diseases. Curr Pharm Biotechnol. 2006 Feb;7(1):15-23. doi: 10.2174/138920106775789647.

  PMID: 16472130 BACKGROUND

• Sachdeva V, Roy A, Bharadvaja N. Current Prospects of Nutraceuticals: A Review. Curr Pharm Biotechnol. 2020;21(10):884-896. doi: 10.2174/1389201021666200130113441.

  PMID: 32000642 BACKGROUND

• Bruins MJ, Van Dael P, Eggersdorfer M. The Role of Nutrients in Reducing the Risk for Noncommunicable Diseases during Aging. Nutrients. 2019 Jan 4;11(1):85. doi: 10.3390/nu11010085.

  PMID: 30621135 BACKGROUND

• Odden MC, Coxson PG, Moran A, Lightwood JM, Goldman L, Bibbins-Domingo K. The impact of the aging population on coronary heart disease in the United States. Am J Med. 2011 Sep;124(9):827-33.e5. doi: 10.1016/j.amjmed.2011.04.010. Epub 2011 Jun 30.

  PMID: 21722862 BACKGROUND

• Musillo C, Borgi M, Saul N, Moller S, Luyten W, Berry A, Cirulli F. Natural products improve healthspan in aged mice and rats: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2021 Feb;121:89-105. doi: 10.1016/j.neubiorev.2020.12.001. Epub 2020 Dec 9.

  PMID: 33309907 BACKGROUND

Central Study Contacts

Voruganti

CONTACT

704-250-5034; vorugantiresearch@unc.edu

Bassem F El-Khodor

CONTACT

262-495-6405; belkhodor@Standardprocess.com

Study Design

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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share