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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00088817 | Other Identifier | Advarra |
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| Name | Class |
|---|---|
| UNC Nutrition Research Institute | OTHER |
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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.
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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Congaplex | Experimental | TP1: 6 capsules/day |
|
| Immuplex | Experimental | TP2: 6 capsules/day |
|
| Gastro-Fiber | Active Comparator | AC: 6 capsules/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune Health (Congaplex) | Dietary Supplement | Supplement related to nail, hair, and immune health |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Voruganti | Contact | 704-250-5034 | vorugantiresearch@unc.edu | |
| Bassem F El-Khodor | Contact | 262-495-6405 | belkhodor@Standardprocess.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11491194 | Background | 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. | |
| 7091289 | 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. |
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| 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 |
|
| 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 |
| 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 |
| 6 months |
| Vitals | Changes in blood pressure [BP] and heart rate from baseline to 3 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 |
| Hepatic Biomarkers | Changes in alanine amino transferase (ALT) 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 |
| 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 |
| Cognition Biomarkers | Changes in folate 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 |
| 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 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 lactate dehydrogenase (LDH) 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 IFN alpha 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 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 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 |
| Metabolic Biomarkers | Changes in C-Peptide from baseline to 3 months, and 6 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 |
| 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 |
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