Eggshell Membrane Beauty From Within Trial

Study Overview
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Brief Summary
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This study is intended to evaluate the efficacy of oral supplementation of an unhydrolyzed eggshell membrane ingredient (uESM) vs placebo on both objective and subjective markers of skin aging in middle-aged and senior adults using the Cutometer® MPA 580 multi-probe system along with specially designed subject questionnaires. Secondary objectives will be to assess the benefits of uESM on the health of hair and fingernails based on a subject questionnaire.

Detailed Description
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This study will be conducted according to a single-center, randomized, double-blind, placebo-controlled trial design. The study protocol will be approved by an independent institutional review board (IRB) and patients will provide their written informed consent to participate. The nutritional ingredient used in this study will be unhydrolyzed eggshell membrane (uESM) (Ovolux™ brand) (ESM Technologies LLC, Carthage, MO. USA), an unhydrolyzed, minimally processed chicken eggshell membrane powder. Up to 90 subjects will be evaluated in this placebo-controlled study at a single investigational site in the U.S. Subjects will be randomly divided into three groups of equal numbers. The first group will receive a treatment protocol consisting of enough capsules to provide a daily dose of two capsules containing one 300 mg capsule of uESM + 1 dummy capsule of psyllium husk fiber, the second group will receive enough capsules for a two capsule daily dose containing two 300 mg capsules of uESM, and a third group will receive enough capsules for a two capsule daily dose containing just psyllium husk fiber as a placebo treatment. Subjects will take the capsules with a morning meal for 12 consecutive weeks. Assessments will be performed at baseline (Day 0), at Week 6 and again at the end of the study (Week 12). After a period of 10-30 minutes at the study facility for acclimation to the study center environment, skin elasticity, firmness, and fatigue will be measured using the Cutometer® MPA 580 multi-probe system by applying a constant negative pressure. Trans-epidermal water loss (TEWL) will be evaluated with the Cutometer® MPA 580 multi-probe system utilizing a TEWL probe, and changes in skin hydration will be measured with the Cutometer® MPA 580 multi-probe system utilizing a corneometer probe. Subjects will also be given questionnaires to evaluate subjective responses to skin look and feel and to evaluate subjects' observations regarding changes in the condition and growth of hair and fingernails.

Official Title
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Evaluation of the Effects of Eggshell Membrane in Protecting Skin From Damage Caused by Environmental Challenges and Aging

Conditions
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Skin Elasticity, Skin Hydration, Skin Barrier to Water Loss, Fingernail Health, Hair Health

Intervention / Treatment
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* Dietary Supplement: unhydrolyzed eggshell membrane
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be male or female, 40-70 years of age and have a light complexion Subject should be generally healthy and free of chronic skin conditions Subject must be able and willing to give informed consent Subject must be available for and willing to attend all evaluation visits Subject must not have used for 30 days prior to screening and be willing to discontinue use of all topical and ingested products expected to improve the health of the skin, hair, or fingernails for the duration of the study (Examples of these types of medicines are: tretinoin (Retin A®), isotretinoin (Accutane®), hyaluronic acid, collagen, topical steroids, topical antibiotics, topical retinol, topical benzoyl peroxide, topical glycolic acid, topical salicylic acid, etc.) Subject must not be a current smoker and have not smoked cigarettes, cigars, a pipe, etc. for 3 months prior to screening and be willing to remain non-smoking for the duration of the study (the use of 'vape' pens is allowed) Subjects participating in prior studies evaluating eggshell membrane can participate in the current study so long as they are not currently taking an eggshell membrane supplement and have not done so for 90 days prior to screening Exclusion Criteria: Subject has had Botox® or other facial injection (dermal filler) at or near the temple area within 6 months of screening Subject has had facial cosmetic surgery affecting skin elasticity/flexibility (e.g. face lift, etc.) Subject has undergone any medical procedure that would materially affect the appearance, texture or elasticity of skin at or near the evaluation sites (face or arm), as judged by the clinical investigator (e.g. chemical peel, laser resurfacing, dermaplaning, microdermabrasion, etc.) within 6 months prior to screening Subject has a known eating disorder or any dysfunction affecting the digestive tract or the ability to digest food properly Subject is taking any medication or substance known to impact gastric or intestinal motility or the body's ability to break down and utilize foods (i.e., weight loss drugs) Subject has been diagnosed with or experienced within 30 days prior to screening any clinically significant confounding disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (e.g. an allergic response resulting in hives or other skin manifestation, an outbreak of rosacea, a severe sunburn, eczema, psoriasis, skin cancer, etc.) Subject has a known allergy to eggs or egg products. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study a. Such sensitivity may be realized as a reaction to inoculations wherein the inoculate is derived from or contains egg components (i.e., influenza vaccine) Subject body weight is greater than 350 pounds (159 kg) Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of baseline evaluation Pregnant and breastfeeding women

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center, randomized, double-blind, single-dummy, placebo-controlled trial design
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low-dose uESM<br>This arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of two capsules containing one 300 mg capsule of uESM + 1 dummy capsule of psyllium husk fiber. | Dietary Supplement: unhydrolyzed eggshell membrane<br>* an unhydrolyzed, minimally processed chicken eggshell membrane powder.<br>* Other names: Ovolux™ brand;|
| Experimental: high-dose uESM<br>This arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of two capsules containing two 300 mg capsules of uESM. | Dietary Supplement: unhydrolyzed eggshell membrane<br>* an unhydrolyzed, minimally processed chicken eggshell membrane powder.<br>* Other names: Ovolux™ brand;|
| Placebo Comparator: Placebo<br>This arm will receive a treatment protocol consisting of enough capsules to provide a daily dose of two capsules containing psyllium husk fiber. | Dietary Supplement: Placebo<br>* psyllium husk fiber powder<br>* Other names: psyllium husk fiber;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin elasticity/firmness | The primary endpoint will be any statistically significant improvement in skin firmness/elasticity in either the anterior region of the temporal fossa of the face or near the antecubital fossa of the arm based upon measurements taken with the Cutometer® MPA 580 multi-probe system. | 6 weeks or 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin hydration | A secondary endpoint will be any statistically significant improvement in skin hydration in either the anterior region of the temporal fossa of the face or near the antecubital fossa of the arm based upon measurements taken with the Cutometer® MPA 580 multi-probe system. | 6 weeks or 12 weeks | 
| skin barrier function | A secondary endpoint will be any statistically significant improvement in trans-epidermal water loss (TEWL) in either the anterior region of the temporal fossa of the face or near the antecubital fossa of the arm based upon measurements taken with the Cutometer® MPA 580 multi-probe system. | 6 weeks or 12 weeks | 
| overall skin health | An additional secondary endpoint will be any statistically significant improvement in overall skin health versus the placebo group as determined via a Patient's Assessment. | 6 weeks or 12 weeks | 
| overall hair health | A final secondary endpoint will be any statistically significant improvement in hair health versus the placebo group as determined via a Patient's Assessment. | 6 weeks or 12 weeks | 
| overall fingernail health | A final secondary endpoint will be any statistically significant improvement fingernail health versus the placebo group as determined via a Patient's Assessment. | 6 weeks or 12 weeks |