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

NCT03679923 | Completed

• 1 other identifier: ESM-CLN#2018T02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover

Keywords

exercise-induced; joint pain; joint stiffness; cartilage turnover; CTX-II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Exercise-induced Joint Pain via questionnaire

  2 weeks

• Exercise-induced Joint Stiffness via questionnaire

  2 weeks

Study Arms (2)

NEM® brand eggshell membrane

EXPERIMENTAL

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

Dietary Supplement: NEM® brand eggshell membrane

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

NEM® brand eggshell membrane DIETARY_SUPPLEMENT

Dietary supplement for the support of joint health.

Also known as: Natural Eggshell Membrane

NEM® brand eggshell membrane

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ESM Technologies, LLC: lead
• QPS Bio-Kinetic: collaborator

Study Sites (1)

QPS Bio-Kinetic

Springfield, Missouri, 65802, United States

Location

Related Publications (1)

• Ruff KJ, Morton KM, Duncan SA, Back M. Eggshell Membrane (NEM®) Reduces Exercise-Induced Joint Pain, Stiffness and Cartilage Turnover in Healthy Men and Women: A Randomized Controlled Trial. Int J Phys Med Rehabil. (2024) 12:722.

  BACKGROUND

Related Links

• International Journal of Physical Medicine \& Rehabilitation Website

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kevin Ruff, Ph.D.

  ESM Technologies, LLC

  STUDY CHAIR

• Christopher Bailey, Ph.D.

  ESM Technologies, LLC

  STUDY DIRECTOR

• Kayce Morton, D.O.

  QPS Bio-Kinetic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: treatment versus placebo

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: September 20, 2018
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)