Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07373574

Effects of Dietary Supplements on Nail and Hair Health

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Nutrient Intake Nutrient Intake Inadequacy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Immune Health (Congaplex)

Dietary Supplement

Supplement related to nail, hair, and immune health

Active Control (Gastro-Fiber)

Dietary Supplement

Supplement not related to immune, hair, or nail health

Immune Health (Immuplex)

Dietary Supplement

Supplement related to nail, hair, and immune health

Primary outcomes

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

    Time frame: 6 months

    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

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 6 months

    Changes in hair density, thickness and pigmentation from baseline to months 3 and 6 of supplementation, measured by trichoscopy. Trichoscopy is a non-invasive procedure that allows a dermatologist to examine the scalp and hair at a high magnification to detect hair and scalp changes.

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

    Time frame: 6 months

    Change in near vision from baseline to months 3 and 6 of supplementation, measured using the Logarithmic Near Vis-ual Acuity Chart 2000 "New ETDRS"

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

    Time frame: 6 months

    Changes in the total scores and subscores of a 36-Item Health Survey Instrument (SF-36) from baseline to months 3 and 6 of supplementation

Other outcomes

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

    Time frame: 6 months

    Reports of adverse events

  2. Anthropometrics

    Time frame: 6 months

    Changes in body mass index [BMI] from baseline to 3 months and six months of supplementation

  3. Vitals

    Time frame: 6 months

    Changes in blood pressure [BP] and heart rate from baseline to 3 and 6 months of supplementation.

  4. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in triglycerides from baseline to 3 months, and 6 months of supplementation

  5. Hepatic Biomarkers

    Time frame: 6 months

    Changes in alanine amino transferase (ALT) from baseline to 3 months, and 6 months of supplementation.

  6. Immune Biomarkers

    Time frame: 6 months

    Changes in immunoglobulin E (IgE) from baseline to 3 months, and 6 months of supplementation.

  7. Adrenal Hormone Biomarkers

    Time frame: 6 months

    Changes in total cortisol from baseline to 3 months, and 6 months of supplementation.

  8. Thyroid Hormone Biomarkers

    Time frame: 6 months

    Changes in Free triiodothyronine (T3) biomarkers from baseline to 3 months, and 6 months of supplementation.

  9. Vitamins and Mineral

    Time frame: 6 months

    Changes in vitamin D and minerals from baseline to 3 months, and 6 months of supplementation.

  10. Cognition Biomarkers

    Time frame: 6 months

    Changes in folate from baseline to 3 months, and 6 months of supplementation.

  11. Polyamine Biomarkers

    Time frame: 6 months

    Changes in spermadine from baseline to 3 months, and 6 months of supplementation.

  12. Other Biomarkers

    Time frame: 6 months

    Changes in autoantibodies against citrullinated and non-citrullinated collagen from baseline to 3 months, and 6 months of supplementation.

  13. Metabolic Biomarkers

    Time frame: 6 months

    Changes in Creatine Kinase (CK) from baseline to 3 months, and 6 months of supplementation.

  14. Metabolic Biomarkers

    Time frame: 6 months

    Changes in Creatinine from baseline to 3 months, and 6 months of supplementation.

  15. Metabolic Biomarkers

    Time frame: 6 months

    Changes in estimated glomerular filtration rate from baseline to 3 months, and 6 months of supplementation.

  16. Metabolic Biomarkers

    Time frame: 6 months

    Changes in glucose from baseline to 3 months, and 6 months of supplementation.

  17. Metabolic Biomarkers

    Time frame: 6 months

    Changes in hemoglobin A1C from baseline to 3 months, and 6 months of supplementation.

  18. Metabolic Biomarkers

    Time frame: 6 months

    Changes in insulin from baseline to 3 months, and 6 months of supplementation.

  19. Metabolic Biomarkers

    Time frame: 6 months

    Changes in lactate dehydrogenase (LDH) from baseline to 3 months, and 6 months of supplementation.

  20. Metabolic Biomarkers

    Time frame: 6 months

    Changes in blood uric acid from baseline to 3 months, and 6 months of supplementation.

  21. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in total cholesterol from baseline to 3 months, and 6 months of supplementation

  22. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in low-density lipoprotein (LDL) from baseline to 3 months, and 6 months of supplementation.

  23. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in high-density lipoprotein cholesterol (HDL-C) from to 3 months, and 6 months of supplementation.

  24. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in lipoprotein (Lpa) from baseline to 3 months, and 6 months of supplementation.

  25. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in apolipoprotein (ApoA) from baseline to 3 months, and 6 months of supplementation.

  26. Lipid Panel Biomarkers

    Time frame: 6 months

    Changes in apolipoprotein (ApoB) from baseline to 3 months, and 6 months of supplementation.

  27. Hepatic Biomarkers

    Time frame: 6 months

    Changes in albumin from baseline to 3 months, and 6 months of supplementation.

  28. Hepatic Biomarkers

    Time frame: 6 months

    Changes in alkaline phosphatase (ALP) from baseline to 3 months, and 6 months of supplementation.

  29. Hepatic Biomarkers

    Time frame: 6 months

    Changes in aspartate aminotransferase (AST) from baseline to 3 months, and 6 months of supplementation.

  30. Hepatic Biomarkers

    Time frame: 6 months

    Changes in C-Reactive protein (CRP) from baseline to 3 months, and 6 months of supplementation.

  31. Hepatic Biomarkers

    Time frame: 6 months

    Changes in gamma-glutamyl transferase (GGT) from baseline to 3 months, and 6 months of supplementation.

  32. Hepatic Biomarkers

    Time frame: 6 months

    Changes in total bilirubin from baseline to 3 months, and 6 months of supplementation.

  33. Hepatic Biomarkers

    Time frame: 6 months

    Changes in globulin from baseline to 3 months, and 6 months of supplementation.

  34. Hepatic Biomarkers

    Time frame: 6 months

    Changes in total protein from baseline to 3 months, and 6 months of supplementation.

  35. Immune Biomarkers

    Time frame: 6 months

    Changes in immunoglobulin M (IgM) from baseline to 3 months, and 6 months of supplementation.

  36. Immune Biomarkers

    Time frame: 6 months

    Changes in immunoglobulin A (IgA) from baseline to 3 months, and 6 months of supplementation.

  37. Immune Biomarkers

    Time frame: 6 months

    Changes in immunoglobulin G (IgG) from baseline to 3 months, and 6 months of supplementation.

  38. Immune Biomarkers

    Time frame: 6 months

    Changes in anti-citrullinated protein antibodies from baseline to 3 months, and 6 months of supplementation.

  39. Adrenal Hormone Biomarkers

    Time frame: 6 months

    Changes in corticosteroid-binding globulin (free cortisol index) from baseline to 3 months, and 6 months of supplementation.

  40. Adrenal Hormone Biomarkers

    Time frame: 6 months

    Changes in dehydroepiandrosterone (DHEA) from baseline to 3 months, and 6 months of supplementation.

  41. Adrenal Hormone Biomarkers

    Time frame: 6 months

    Changes in estradiol from baseline to 3 months, and 6 months of supplementation.

  42. Adrenal Hormone Biomarkers

    Time frame: 6 months

    Changes in sex hormone-binding globulin (SHBG) from baseline to 3 months, and 6 months of supplementation.

  43. Adrenal Hormone Biomarkers

    Time frame: 6 months

    Changes in testosterone from baseline to 3 months, and 6 months of supplementation.

  44. Thyroid Hormone Biomarkers

    Time frame: 6 months

    Changes in free thyroxine (T4) from baseline to 3 months, and 6 months of supplementation.

  45. Thyroid Hormone Biomarkers

    Time frame: 6 months

    Changes in total T3 from baseline to 3 months, and 6 months of supplementation.

  46. Thyroid Hormone Biomarkers

    Time frame: 6 months

    Changes in total T4 from baseline to 3 months, and 6 months of supplementation.

  47. Thyroid Hormone Biomarkers

    Time frame: 6 months

    Changes in thyroid stimulating hormone (TSH) from baseline to 3 months, and 6 months of supplementation.

  48. Thyroid Hormone Biomarkers

    Time frame: 6 months

    Changes in triiodothyronine uptake test from baseline to 3 months, and 6 months of supplementation.

  49. Vitamins and Mineral

    Time frame: 6 months

    Changes in ferritin from baseline to 3 months, and 6 months of supplementation.

  50. Vitamins and Mineral

    Time frame: 6 months

    Changes in iron from baseline to 3 months, and 6 months of supplementation.

  51. Vitamins and Mineral

    Time frame: 6 months

    Changes in chloride from baseline to 3 months, and 6 months of supplementation.

  52. Vitamins and Mineral

    Time frame: 6 months

    Changes in phosphorus from baseline to 3 months, and 6 months of supplementation.

  53. Vitamins and Mineral

    Time frame: 6 months

    Changes in potassium from baseline to 3 months, and 6 months of supplementation.

  54. Vitamins and Mineral

    Time frame: 6 months

    Changes in sodium from baseline to 3 months, and 6 months of supplementation.

  55. Vitamins and Mineral

    Time frame: 6 months

    Changes in calcium from baseline to 3 months, and 6 months of supplementation.

  56. Vitamins and Mineral

    Time frame: 6 months

    Changes in magnesium from baseline to 3 months, and 6 months of supplementation.

  57. Cognition Biomarkers

    Time frame: 6 months

    Changes in homocysteine from baseline to 3 months, and 6 months of supplementation.

  58. Cognition Biomarkers

    Time frame: 6 months

    Changes in vitamin B12 from baseline to 3 months, and 6 months of supplementation.

  59. Polyamine Biomarkers

    Time frame: 6 months

    Changes in spermine from baseline to 3 months, and 6 months of supplementation.

  60. Polyamine Biomarkers

    Time frame: 6 months

    Changes in histamine from baseline to 3 months, and 6 months of supplementation.

  61. Polyamine Biomarkers

    Time frame: 6 months

    Changes in putrescine from baseline to 3 months, and 6 months of supplementation.

  62. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-1 receptor antagonist protein (IL-1RN) from baseline to 3 months, and 6 months of supplementation.

  63. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-6 from baseline to 3 months, and 6 months of supplementation.

  64. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-8 from baseline to 3 months, and 6 months of supplementation.

  65. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-13 from baseline to 3 months, and 6 months of supplementation.

  66. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IFN alpha from baseline to 3 months, and 6 months of supplementation.

  67. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-18 from baseline to 3 months, and 6 months of supplementation.

  68. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IFN beta from baseline to 3 months, and 6 months of supplementation.

  69. Inflammation Biomarkers

    Time frame: 6 months

    Changes in TGFs from baseline to 3 months, and 6 months of supplementation.

  70. Inflammation Biomarkers

    Time frame: 6 months

    Changes in TNFs from baseline to 3 months, and 6 months of supplementation.

  71. Inflammation Biomarkers

    Time frame: 6 months

    Changes in serum amyloid A from baseline to 3 months, and 6 months of supplementation.

  72. Inflammation Biomarkers

    Time frame: 6 months

    Changes in serum tau from baseline to 3 months, and 6 months of supplementation.

  73. Inflammation Biomarkers

    Time frame: 6 months

    Changes in neurofilament light from baseline to 3 months, and 6 months of supplementation.

  74. Inflammation Biomarkers

    Time frame: 6 months

    Changes in S100B from baseline to 3 months, and 6 months of supplementation.

  75. Inflammation Biomarkers

    Time frame: 6 months

    Changes in GFAP from baseline to 3 months, and 6 months of supplementation.

  76. Inflammation Biomarkers

    Time frame: 6 months

    Changes in NLR from baseline to 3 months, and 6 months of supplementation.

  77. Inflammation Biomarkers

    Time frame: 6 months

    Changes in biomarkers from CRP to 3 months, and 6 months of supplementation.

  78. Inflammation Biomarkers

    Time frame: 6 months

    Changes in CAR from baseline to 3 months, and 6 months of supplementation.

  79. Other Biomarkers

    Time frame: 6 months

    Changes in fibronectin from baseline to 3 months, and 6 months of supplementation.

  80. Other Biomarkers

    Time frame: 6 months

    Changes in vimentin from baseline to 3 months, and 6 months of supplementation.

  81. Other Biomarkers

    Time frame: 6 months

    Changes in NSE from baseline to 3 months, and 6 months of supplementation.

  82. Other Biomarkers

    Time frame: 6 months

    Changes in ICAM from baseline to 3 months, and 6 months of supplementation.

  83. Other Biomarkers

    Time frame: 6 months

    Changes in actin from baseline to 3 months, and 6 months of supplementation.

  84. Other Biomarkers

    Time frame: 6 months

    Changes in zonulin from baseline to 3 months, and 6 months of supplementation.

  85. Other Biomarkers

    Time frame: 6 months

    Changes in MYH7 from baseline to 3 months, and 6 months of supplementation.

  86. Other Biomarkers

    Time frame: 6 months

    Changes in myoglobin from baseline to 3 months, and 6 months of supplementation.

  87. Other Biomarkers

    Time frame: 6 months

    Changes in troponin from baseline to 3 months, and 6 months of supplementation.

  88. Metabolic Biomarkers

    Time frame: 6 months

    Changes in C-Peptide from baseline to 3 months, and 6 months of supplementation.

  89. Metabolic Biomarkers

    Time frame: 6 months

    Changes in blood urea nitrogen (BUN) from baseline to 3 months, and 6 months of supplementation.

  90. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-1 antagonist protein (IL-1RN) from baseline to 3 months, and 6 months of supplementation.

  91. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-2 from baseline to 3 months, and 6 months of supplementation.

  92. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-10 from baseline to 3 months, and 6 months of supplementation.

  93. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IL-11 from baseline to 3 months, and 6 months of supplementation.

  94. Inflammation Biomarkers

    Time frame: 6 months

    Changes in IFN gamma from baseline to 3 months, and 6 months of supplementation.

  95. Inflammation Biomarkers

    Time frame: 6 months

    Changes in GM-CSF from baseline to 3 months, and 6 months of supplementation.

  96. Other Biomarkers

    Time frame: 6 months

    Changes in non-citrullinated collagen from baseline to 3 months, and 6 months of supplementation.

Study contacts

Contact information is provided by the study sponsor or research team.

Bassem F El-Khodor

CONTACT

[email protected]

262-495-6405

Voruganti

CONTACT

[email protected]

704-250-5034

Sponsors and collaborators

Lead sponsor

Standard Process Inc.

Industry

Collaborators

  • UNC Nutrition Research Institute

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.