Exercise-induced Joint Pain Stiffness and Cartilage TurnoverNCT02751944
NEM® Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover In Healthy, Post-Menopausal Women
A study testing NEM in people with Exercise-induced Joint Pain Stiffness and Cartilage Turnover, run by ESM Technologies, LLC.
Trial 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 post-menopausal women. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Joint Pain Stiffness and Cartilage Turnover
- What is being tested?
- NEM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be female, 40-75 years of age.
- Subject must have been amenorrheic (post-menopausal) for at least 12 months prior to baseline evaluation, either naturally or surgically.
- Subject must not have been diagnosed with a joint or connective tissue (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.
- Subjects must have a resting pain/discomfort score of ≤ 3 on the 10 point Likert scale in the knee with the most severe pain/discomfort.
- Subject must be willing and healthy enough to perform moderate exercise.
- Subject must be available for and willing to attend all evaluation visits.
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- Subject 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 can participate in the current study so long as they are not currently taking an eggshell membrane supplement and have not done so for 60 days prior to screening.
Who cannot join
- Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, tumor necrosis factor (TNF) biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.).
- 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 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.
- 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 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.
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- Subject body weight is greater than 275 pounds (125 kg).
- 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 prescribed for painful conditions (i.e. fibromyalgia) \& 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.
- 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, methylsulfonylmethane (MSM), etc.) Acetaminophen must not have been taken within 24 hours of 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 baseline evaluation.
- Pregnant and breastfeeding women.
- Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.
About this study
Official title: Evaluation of the Effects of NEM® Brand Eggshell Membrane Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy, Post-menopausal Women
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 post-menopausal 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.
Read the 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, if any, 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 50 steps per leg utilizing an aerobics step at the clinical site. They will follow this exercise regimen on alternating days for 2 weeks. Changes in pain \& stiffness (immediate \& 12-hour) will be compared to both baseline and to the placebo group. Blood \& Urine samples will also be collected at baseline and at the end of Week 1 \& Week 2. The change in CTX-II will be compared to baseline.
- Being tested
- NEM, Placebo
- Keywords
- exercise-induced, joint pain, joint stiffness, post-menopausal, women, cartilage turnover, CTX-II
- Medical subject headings
- Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEMDietary supplement
Also called Natural Eggshell Membrane
Dietary supplement for the support of joint health.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NEM Treatment | Experimental | NEM, 500 mg, once daily, orally for 2 weeks Receives: Dietary Supplement: NEM |
| Placebo | Placebo comparator | Placebo, 500 mg, once daily, orally for 2 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise-induced Cartilage Turnover via CTX-II Biomarker
To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced cartilage turnover in healthy, post-menopausal women by evaluating the change in urinary CTX-II levels.
Measured: 2 weeks
Secondary outcomes (2)
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 10 point Likert scale.
Measured: 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 10 point Likert scale.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced Joint Pain Stiffness and Cartilage TurnoverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESM Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Morrison, D.O., Principal investigator, QPS-BiokineticKevin J Ruff, Ph.D., MBA, Study director, ESM Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751944
- Sponsor's protocol ID
- ESM-CLN#2015T02
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2016
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ruff KJ, Morrison D, Duncan SA, Back M, Aydogan C, Theodosakis J. Beneficial effects of natural eggshell membrane versus placebo in exercise-induced joint pain, stiffness, and cartilage turnover in healthy, postmenopausal women. Clin Interv Aging. 2018 Feb 19;13:285-295. doi: 10.2147/CIA.S153782. eCollection 2018.
PubMed 29497287
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of NEM® Brand Eggshell Membrane Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy, Post-menopausal Women
- ClinicalTrials.gov ID
- NCT02751944
- Acronym / sponsor ID
- ESM-CLN#2015T02
- Keywords
- exercise-induced, joint pain, joint stiffness, post-menopausal, women, cartilage turnover, CTX-II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ESM Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 post-menopausal 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.
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, if any, 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 50 steps per leg utilizing an aerobics step at the clinical site. They will follow this exercise regimen on alternating days for 2 weeks. Changes in pain \& stiffness (immediate \& 12-hour) will be compared to both baseline and to the placebo group. Blood \& Urine samples will also be collected at baseline and at the end of Week 1 \& Week 2. The change in CTX-II will be compared to baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEM Treatment | Experimental | Dietary Supplement: NEMNEM, 500 mg, once daily, orally for 2 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, 500 mg, once daily, orally for 2 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be female, 40-75 years of age.
- Subject must have been amenorrheic (post-menopausal) for at least 12 months prior to baseline evaluation, either naturally or surgically.
- Subject must not have been diagnosed with a joint or connective tissue (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.
- Subjects must have a resting pain/discomfort score of ≤ 3 on the 10 point Likert scale in the knee with the most severe pain/discomfort.
- Subject must be willing and healthy enough to perform moderate exercise.
Key exclusion criteria (12 listed)
- Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, tumor necrosis factor (TNF) biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.).
- 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 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEMAlso: Natural Eggshell MembraneDietary supplement for the support of joint health. | Dietary supplement | NEM Treatment |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Exercise-induced Cartilage Turnover via CTX-II Biomarker
Time frame: 2 weeks
To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced cartilage turnover in healthy, post-menopausal women by evaluating the change in urinary CTX-II levels.
2 secondary outcomes
Exercise-induced Joint Pain via questionnaire
Time frame: 2 weeks
Exercise-induced Joint Stiffness via questionnaire
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Results publication: PubMed 29497287Ruff KJ, Morrison D, Duncan SA, Back M, Aydogan C, Theodosakis J. Beneficial effects of natural eggshell membrane versus placebo in exercise-induced joint pain, stiffness, and cartilage turnover in healthy, postmenopausal women. Clin Interv Aging. 2018 Feb 19;13:285-295. doi: 10.2147/CIA.S153782. eCollection 2018.
- Published in Clinical Interventions in AgingLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Exercise-induced Joint Pain Stiffness and Cartilage Turnover
Recruiting
Effects of Eggshell Membrane and Curcumin Extract Supplementation, Separately or Combined, on Recovery From Intense Exercise
Exercise-induced Muscle Soreness, Exercise-induced Joint Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Morrison, D.O. principal investigator
QPS-Biokinetic
Kevin J Ruff, Ph.D., MBA study director
ESM Technologies, LLC
Questions about this trial
What is this clinical trial studying?
A study testing NEM in people with Exercise-induced Joint Pain Stiffness and Cartilage Turnover, run by ESM Technologies, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise-induced Cartilage Turnover via CTX-II Biomarker (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.