NEM® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women

Study Overview
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Brief Summary
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This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell membrane versus placebo in reducing exercise-induced joint pain, stiffness & cartilage turnover in healthy men & women. Half of the study participants will receive NEM, once daily, orally while the other half of the study participants will receive placebo, once daily, orally while performing an exercise regimen every other day for two weeks.

Detailed Description
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Moderate exercise can induce discomfort in joints when done infrequently or when done too intensely or for too long a period. This discomfort is often realized as either pain or stiffness in the joint that was the focus of the exercise. For example, one's knees will hurt after jogging for several miles, particularly if jogging for the first time. This study is intended to evaluate whether NEM® brand eggshell membrane can alleviate joint pain or stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The study will also evaluate NEM's effect, on cartilage turnover via the cartilage degradation biomarker c-terminal cross-linked telopeptide of type II collagen (CTX-II). Participants will perform a minimum of 40 steps per leg utilizing an aerobics step at the clinical site. They will follow this exercise regimen on alternating days for 2 consecutive weeks. Changes in pain & stiffness (immediate & 12-hour) will be compared to both baseline and to the placebo group. Urine samples will also be collected at baseline and at the end of Week 1 & Week 2. The change in CTX-II from baseline will be compared to the placebo group.

Official Title
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Efficacy of NEM® Brand Eggshell Membrane Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women

Conditions
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Exercise-induced Joint Pain, Exercise-induced Joint Stiffness, Exercise-induced Joint Cartilage Turnover

Intervention / Treatment
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* Dietary Supplement: NEM® brand eggshell membrane
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female subjects must be 40-75 years of age at the time of Screening. Subjects must not have been diagnosed with a JCT disease (i.e. osteoarthritis, rheumatoid arthritis, spondyloarthritis, bursitis, gout, systemic lupus erythematosus, fibromyalgia, etc.) affecting the hip, knee, or ankle by a licensed physician prior to enrollment evaluation / screening. Subjects must have a resting pain/discomfort score of ≤ 2 on the 10-point continuous scale in the knee with the most severe pain/discomfort at the Follow-Up Screening/Baseline (first exercise visit). Subjects must be willing and healthy enough, as judged by the clinical Investigator or Sub-Investigator(s), to perform moderate exercise. Subjects must be available for and willing to attend all evaluation visits. Subjects must be able and willing to give informed consent. Subjects must be willing to use only acetaminophen as rescue pain medication, if needed. Subjects participating in prior studies evaluating eggshell membrane, curcumin, fish oil or collagen can participate in the present study so long as they are not currently taking an eggshell membrane, fish oil, curcumin, or collagen supplement and have not done so for 60 days prior to screening. Exclusion Criteria: Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.) or planning to use these products during the study period. Subject has been diagnosed with any clinically significant confounding inflammatory disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (i.e. pseudo gout, Paget's disease, chronic pain syndrome, active rheumatic fever, etc.). Subject has known allergy to any of the investigational products, including but not limited to eggs or egg products and rice or rice flour. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study. Subject suffers from clinically significant cardiac, pulmonary, or other complications that would prevent them from performing moderate exercise or could pose a risk to the subject's health, as judged by the clinical investigator. Subject participates in activities involving intensive use of the lower extremities (i.e. running / jogging, sports, bicycling, dancing, etc.) 2 or more days per week or participates in activities that involve moderate use of the lower extremities (i.e. walking, golfing, yoga, etc.) 3 or more days per week. Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening. Subject is currently taking or is unwilling to forgo the use of prescription, over-the-counter (OTC) treatments, and/or dietary supplements affecting joint health within 30 days prior to baseline evaluation and for the duration of the study. Prohibited medications include: NSAIDs, analgesics (other than acetaminophen), opioids, anti-depressants (of all drug classes for this indication, including but not limited to SSRI's such as citalopram and fluoxetine, TCA's such as amitriptyline and amoxapine, SNRI's such as duloxetine or SNRI's used for fibromyalgia such as milnacipran and NDRI's such as bupropion), other medications for the management of painful conditions (i.e. fibromyalgia) including gabapentin and tizanidine & joint supplements. Examples of these types of medications are: aspirin, ibuprofen, naproxen, oxycodone, propoxyphene, diclofenac, celecoxib, amitriptyline, duloxetine, glucosamine, chondroitin, MSM, white willow bark, turmeric or curcumin, Boswellia, fish oil, etc. a. Washout Periods: Subjects are eligible to participate in the study following a 7-day washout period for opioids, a 14-day washout period for analgesics & NSAIDs, and a 90-day washout period for steroids, anti-depressants, or JCT dietary supplements (i.e. glucosamine, chondroitin, MSM, etc.) Acetaminophen must not have been taken within 24 hours of the first baseline evaluation. 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 the first baseline evaluation. Pregnant and breastfeeding women, or women who intend to become pregnant during the course of the study. Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: treatment versus placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEM® brand eggshell membrane<br>NEM, 500 mg, #0 capsule, once daily orally for 2 weeks | Dietary Supplement: NEM® brand eggshell membrane<br>* Dietary supplement for the support of joint health.<br>* Other names: Natural Eggshell Membrane;|
| Placebo Comparator: Placebo<br>Placebo, 500 mg, #0 capsule, once daily orally for 2 weeks | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise-induced Cartilage Turnover via CTX-II Biomarker | To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced cartilage turnover in healthy men & women by evaluating the change in urinary CTX-II levels. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise-induced Joint Pain via questionnaire | To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced knee discomfort (pain/aching) based upon perceived pain rated on a 0-10 point continuous scale (where 0 = no pain).. | 2 weeks | 
| Exercise-induced Joint Stiffness via questionnaire | To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced knee stiffness based upon perceived stiffness rated on a 0-10 point continuous scale (where 0 = no stiffness). | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTX-II, exercise-induced, joint pain, joint stiffness, cartilage turnover