Nutrient Intake, Nutrient Intake Inadequacy
Conditions
Keywords
Nutrition, Hair Health, Nail Health
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.
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®.
Interventions
DIETARY_SUPPLEMENTImmune Health (Congaplex)
Supplement related to nail, hair, and immune health
DIETARY_SUPPLEMENTActive Control (Gastro-Fiber)
Supplement not related to immune, hair, or nail health
DIETARY_SUPPLEMENTImmune Health (Immuplex)
Supplement related to nail, hair, and immune health
Sponsors
Standard Process Inc.
UNC Nutrition Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the effects of TP1/2 versus AC on nail biostructure and biochemical composition after 6 months of supplementation | 6 months | Changes in Raman spectra of fingernail tissue at baseline (V2) compared to month 6 (V4) of supplementation |
| Determine the effects of test products (TP1/2) versus active control (AC) on numbers and severity of longitudinal (vertical) nail ridges | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the effects of test products TP1/2 versus AC on density, thickness and pigmentation of hair | 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. |
| Determine the effects of TP1/2 versus AC on near vision (visual accommodation) | 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" |
| Determine the effects of TP1/2 versus AC on the scores of general health questionnaire | 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 |
Outcome results
None listed