Effects of Dietary Supplements on Nail and Hair Health

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

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrient Intake Inadequacy; Nutrient Intake
• Intervention / Treatment: Dietary supplement: Immune Health (Congaplex); Dietary supplement: Immune Health (Immuplex); Dietary supplement: Active Control (Gastro-Fiber)

Detailed Description

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®.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Voruganti; Phone Number: 704-250-5034; Email: vorugantiresearch@unc.edu
• Study Contact Backup: Name: Bassem F El-Khodor; Phone Number: 262-495-6405; Email: belkhodor@Standardprocess.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

INCLUSION CRITERIA:

1. Healthy female and male adults who are 18 to 75 years of age (inclusive)
2. Display longitudinal (vertical) nail ridges in the absence of other nail abnormalities
3. 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)
4. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product

5. 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:

   1. 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
   2. 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
   3. 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.
6. Agree to refrain from treatments listed in Section 8.3 in the defined timeframe
7. 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
8. 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:

1. Individuals who are lactating, pregnant or planning to become pregnant during the study as con-firmed at the baseline visit (Visit 2)
2. Individuals who have applied cosmetic/topical treatments to fingernails in the past 6 months (i.e., manicures with nail plate filing, nail polish)
3. 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])
4. Individuals with active nail biting (onychophagia) or other behaviors that may affect nail integrity
5. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients
6. Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit
7. Individuals opposed to consuming animal products
8. Have a history of uncontrolled hypertension (140/90 or greater mmHg), kidney dysfunction or dis-ease (dialysis or renal failure), hepatic impairment or disease
9. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Congaplex; TP1: 6 capsules/day	Dietary supplement: Immune Health (Congaplex); Supplement related to nail, hair, and immune health
Experimental: Immuplex; TP2: 6 capsules/day	Dietary supplement: Immune Health (Immuplex); Supplement related to nail, hair, and immune health
Active Comparator: Gastro-Fiber; AC: 6 capsules/day	Dietary supplement: Active Control (Gastro-Fiber); Supplement not related to immune, hair, or nail health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effects of TP1/2 versus AC on the scores of general health questionnaire	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	6 months
Determine the effects of test products TP1/2 versus AC on density, thickness and pigmentation of hair	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.	6 months
Determine the effects of TP1/2 versus AC on near vision (visual accommodation)	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"	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the safety and tolerability of TP1/2 and AC in healthy participants	Reports of adverse events	6 months
Anthropometrics	Changes in body mass index [BMI] from baseline to 3 months and six months of supplementation	6 months
Metabolic Biomarkers	Changes in blood urea nitrogen (BUN) from baseline to 3 months, and 6 months of supplementation.	6 months
Lipid Panel Biomarkers	Changes in triglycerides from baseline to 3 months, and 6 months of supplementation	6 months
Immune Biomarkers	Changes in immunoglobulin E (IgE) from baseline to 3 months, and 6 months of supplementation.	6 months
Adrenal Hormone Biomarkers	Changes in total cortisol from baseline to 3 months, and 6 months of supplementation.	6 months
Cognition Biomarkers	Changes in folate from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in autoantibodies against citrullinated and non-citrullinated collagen from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in C-Peptide from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in Creatine Kinase (CK) from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in Creatinine from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in estimated glomerular filtration rate from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in glucose from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in hemoglobin A1C from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in insulin from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in blood uric acid from baseline to 3 months, and 6 months of supplementation.	6 months
Lipid Panel Biomarkers	Changes in total cholesterol from baseline to 3 months, and 6 months of supplementation	6 months
Lipid Panel Biomarkers	Changes in low-density lipoprotein (LDL) from baseline to 3 months, and 6 months of supplementation.	6 months
Lipid Panel Biomarkers	Changes in high-density lipoprotein cholesterol (HDL-C) from to 3 months, and 6 months of supplementation.	6 months
Lipid Panel Biomarkers	Changes in lipoprotein (Lpa) from baseline to 3 months, and 6 months of supplementation.	6 months
Lipid Panel Biomarkers	Changes in apolipoprotein (ApoA) from baseline to 3 months, and 6 months of supplementation.	6 months
Lipid Panel Biomarkers	Changes in apolipoprotein (ApoB) from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in albumin from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in alkaline phosphatase (ALP) from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in aspartate aminotransferase (AST) from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in C-Reactive protein (CRP) from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in gamma-glutamyl transferase (GGT) from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in total bilirubin from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in globulin from baseline to 3 months, and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in total protein from baseline to 3 months, and 6 months of supplementation.	6 months
Immune Biomarkers	Changes in immunoglobulin M (IgM) from baseline to 3 months, and 6 months of supplementation.	6 months
Immune Biomarkers	Changes in immunoglobulin A (IgA) from baseline to 3 months, and 6 months of supplementation.	6 months
Immune Biomarkers	Changes in immunoglobulin G (IgG) from baseline to 3 months, and 6 months of supplementation.	6 months
Immune Biomarkers	Changes in anti-citrullinated protein antibodies from baseline to 3 months, and 6 months of supplementation.	6 months
Adrenal Hormone Biomarkers	Changes in corticosteroid-binding globulin (free cortisol index) from baseline to 3 months, and 6 months of supplementation.	6 months
Adrenal Hormone Biomarkers	Changes in dehydroepiandrosterone (DHEA) from baseline to 3 months, and 6 months of supplementation.	6 months
Adrenal Hormone Biomarkers	Changes in estradiol from baseline to 3 months, and 6 months of supplementation.	6 months
Adrenal Hormone Biomarkers	Changes in sex hormone-binding globulin (SHBG) from baseline to 3 months, and 6 months of supplementation.	6 months
Adrenal Hormone Biomarkers	Changes in testosterone from baseline to 3 months, and 6 months of supplementation.	6 months
Thyroid Hormone Biomarkers	Changes in free thyroxine (T4) from baseline to 3 months, and 6 months of supplementation.	6 months
Thyroid Hormone Biomarkers	Changes in total T3 from baseline to 3 months, and 6 months of supplementation.	6 months
Thyroid Hormone Biomarkers	Changes in total T4 from baseline to 3 months, and 6 months of supplementation.	6 months
Thyroid Hormone Biomarkers	Changes in thyroid stimulating hormone (TSH) from baseline to 3 months, and 6 months of supplementation.	6 months
Thyroid Hormone Biomarkers	Changes in triiodothyronine uptake test from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in ferritin from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in iron from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in chloride from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in phosphorus from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in potassium from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in sodium from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in calcium from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in magnesium from baseline to 3 months, and 6 months of supplementation.	6 months
Cognition Biomarkers	Changes in homocysteine from baseline to 3 months, and 6 months of supplementation.	6 months
Cognition Biomarkers	Changes in vitamin B12 from baseline to 3 months, and 6 months of supplementation.	6 months
Polyamine Biomarkers	Changes in spermine from baseline to 3 months, and 6 months of supplementation.	6 months
Polyamine Biomarkers	Changes in histamine from baseline to 3 months, and 6 months of supplementation.	6 months
Polyamine Biomarkers	Changes in putrescine from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-1 receptor antagonist protein (IL-1RN) from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-6 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-8 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-13 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-18 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IFN beta from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in serum amyloid A from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in serum tau from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in neurofilament light from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in S100B from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in GFAP from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in NLR from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in biomarkers from CRP to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in CAR from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in fibronectin from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in vimentin from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in NSE from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in ICAM from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in actin from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in zonulin from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in MYH7 from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in myoglobin from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in troponin from baseline to 3 months, and 6 months of supplementation.	6 months
Vitals	Changes in blood pressure [BP] and heart rate from baseline to 3 and 6 months of supplementation.	6 months
Hepatic Biomarkers	Changes in alanine amino transferase (ALT) from baseline to 3 months, and 6 months of supplementation.	6 months
Thyroid Hormone Biomarkers	Changes in Free triiodothyronine (T3) biomarkers from baseline to 3 months, and 6 months of supplementation.	6 months
Vitamins and Mineral	Changes in vitamin D and minerals from baseline to 3 months, and 6 months of supplementation.	6 months
Polyamine Biomarkers	Changes in spermadine from baseline to 3 months, and 6 months of supplementation.	6 months
Metabolic Biomarkers	Changes in lactate dehydrogenase (LDH) from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IFN alpha from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in TGFs from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in TNFs from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-1 antagonist protein (IL-1RN) from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-2 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-10 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IL-11 from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in IFN gamma from baseline to 3 months, and 6 months of supplementation.	6 months
Inflammation Biomarkers	Changes in GM-CSF from baseline to 3 months, and 6 months of supplementation.	6 months
Other Biomarkers	Changes in non-citrullinated collagen from baseline to 3 months, and 6 months of supplementation.	6 months

Collaborators and Investigators

• Sponsor: Standard Process Inc.
• Collaborators: UNC Nutrition Research Institute

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Nutrition; Hair Health; Nail Health
• Other Study ID Numbers: SPD-01; Pro00088817 (Other Identifier: Advarra)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No