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

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

Sponsors

Lead Sponsor: ESM Technologies, LLC

Collaborator: QPS Bio-Kinetic

Source ESM Technologies, LLC
Brief Summary

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

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.

Overall Status Completed
Start Date September 20, 2018
Completion Date November 13, 2018
Primary Completion Date November 13, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Exercise-induced Cartilage Turnover via CTX-II Biomarker 2 weeks
Secondary Outcome
Measure Time Frame
Exercise-induced Joint Pain via questionnaire 2 weeks
Exercise-induced Joint Stiffness via questionnaire 2 weeks
Enrollment 84
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: NEM® brand eggshell membrane

Description: Dietary supplement for the support of joint health.

Arm Group Label: NEM® brand eggshell membrane

Other Name: Natural Eggshell Membrane

Intervention Type: Dietary Supplement

Intervention Name: Placebo

Description: Placebo

Arm Group Label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

1. Male or Female subjects must be 40-75 years of age at the time of Screening.

2. 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.

3. 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).

4. Subjects must be willing and healthy enough, as judged by the clinical Investigator or Sub-Investigator(s), to perform moderate exercise.

5. Subjects must be available for and willing to attend all evaluation visits.

6. Subjects must be able and willing to give informed consent.

7. Subjects must be willing to use only acetaminophen as rescue pain medication, if needed.

8. 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:

1. 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.

2. 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.).

3. 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.

4. 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.

5. 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.

6. Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.

7. 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.

8. 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.

9. Pregnant and breastfeeding women, or women who intend to become pregnant during the course of the study.

10. Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.

Gender: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: QPS Bio-Kinetic
Location Countries

United States

Verification Date

December 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: NEM® brand eggshell membrane

Type: Experimental

Description: NEM, 500 mg, #0 capsule, once daily orally for 2 weeks

Label: Placebo

Type: Placebo Comparator

Description: Placebo, 500 mg, #0 capsule, once daily orally for 2 weeks

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: treatment versus placebo

Primary Purpose: Supportive Care

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov