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. We value your participation.
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® supplements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
Supplement related to nail, hair, and immune health
Supplement not related to immune, hair, or nail health
Supplement related to nail, hair, and immune health
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 from baseline to months 3 and 6 of supplementation. Higher number of vertical ridges indicate poorer outcome.
Time frame: 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 and surround tissue from baseline to month 6 of supplementation
Time frame: 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 examination of the scalp and hair at a high magnification to examine hair and scalp health. This will look at the quality of the hair.
Time frame: 6 months
Determine the effects of TP1/2 versus AC on hair biostructure and biochemical compositions after 3 and 6 months of supplementation
Changes in Raman spectra of newly grown parts of nail from baseline to months 3 and 6 of supplementation to compare quality of nail structure
Time frame: 6 months
Determine the effects of TP1/2 versus AC on near vision (visual accommodation)
Change in vision and near vision from baseline to months 3 and 6 of supplementation, measured using a Bailey Lovie Chart
Time frame: 6 months
Determine the effects of TP1/2 versus AC on the scores of general health questionnaire
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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
Time frame: 6 months