Exercise-induced Joint PainNCT03769857
NEM® + BIOCURC® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
A study testing NEM® + BIOCURC® in people with Exercise-induced Joint Pain and Exercise-induced Joint Stiffness, run by ESM Technologies, LLC at 1 site in United States.
Trial summary
This study is intended to evaluate the combined effects of the dietary supplement NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin versus placebo in reducing exercise-induced joint pain, stiffness \& cartilage turnover in healthy men \& women. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Joint Pain, Exercise-induced Joint Stiffness, Exercise-induced Joint Cartilage Turnover
- What is being tested?
- NEM® + BIOCURC®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2019to 15 Apr 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of NEM® Brand Eggshell Membrane Plus BIOCURC® Brand Bioavailable Curcumin Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
This study is intended to evaluate the combined effects of the dietary supplement NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin versus placebo in reducing exercise-induced joint pain, stiffness \& cartilage turnover in healthy men \& women. Half of the study participants will receive NEM+BIOCURC, 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.
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 the combination of NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin can alleviate joint pain or stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The study will also evaluate the combination'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 50 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.
- Conditions
- Exercise-induced Joint Pain, Exercise-induced Joint Stiffness, Exercise-induced Joint Cartilage Turnover
- Being tested
- NEM® + BIOCURC®, Placebo
- Keywords
- exercise-induced, joint pain, joint stiffness, 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.
NEM® + BIOCURC®Dietary supplement
Dietary supplement combination for the support of joint health.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NEM® + BIOCURC® | Experimental | NEM® + BIOCURC®
NEM, 500 mg, #0 capsule, once daily orally for 2 weeks PLUS BIOCURC, 350 mg, #10 oval softgel, once daily orally for 2 weeks Receives: Dietary Supplement: NEM® + BIOCURC® |
| Placebo | Placebo comparator | Placebo, 500 mg, #0 capsule, once daily orally for 2 weeks PLUS Placebo, 350 mg, #10 oval softgel, 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®+BIOCURC® versus placebo at reducing exercise-induced cartilage turnover in healthy men \& 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®+BIOCURC® 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).
Measured: 2 Weeks
Exercise-induced Joint Stiffness via questionnaire
To evaluate the efficacy of NEM®+BIOCURC® versus placebo at reducing exercise-induced knee stiffness based upon perceived stiffness rated on a 0-10 point continuous scale (where 0 = no stiffness).
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 posted10 Dec 2018
- Study start13 Jan 2019
- Primary completion20 Feb 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced Joint PainStudies 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
- Model description
- treatment versus placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ESM Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QPS Bio-Kinetic
- Responsible party
- Sponsor
- Investigators
- Kevin Ruff, Ph.D., Study chair, ESM Technologies, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769857
- Sponsor's protocol ID
- ESM-CLN#2019T01
- Status last verified
- Jul 2019
- First submitted
- 6 Dec 2018
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of NEM® Brand Eggshell Membrane Plus BIOCURC® Brand Bioavailable Curcumin Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
- ClinicalTrials.gov ID
- NCT03769857
- Acronym / sponsor ID
- ESM-CLN#2019T01
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ESM Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- QPS Bio-Kinetic
- Study start
- 13 Jan 2019 (actual)
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 10 Dec 2018 (actual)
- 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 combined effects of the dietary supplement NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin versus placebo in reducing exercise-induced joint pain, stiffness \& cartilage turnover in healthy men \& women. Half of the study participants will receive NEM+BIOCURC, 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 the combination of NEM® brand eggshell membrane and BIOCURC® brand bioavailable curcumin can alleviate joint pain or stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The study will also evaluate the combination'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 50 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.
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
- Model description
- treatment versus placebo
| Arm | Type | Receives |
|---|---|---|
| NEM® + BIOCURC® | Experimental | Dietary Supplement: NEM® + BIOCURC®NEM® + BIOCURC® NEM, 500 mg, #0 capsule, once daily orally for 2 weeks PLUS BIOCURC, 350 mg, #10 oval softgel, once daily orally for 2 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo, 500 mg, #0 capsule, once daily orally for 2 weeks PLUS Placebo, 350 mg, #10 oval softgel, once daily orally for 2 weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| NEM® + BIOCURC®Dietary supplement combination for the support of joint health. | Dietary supplement | NEM® + BIOCURC® |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Exercise-induced Cartilage Turnover via CTX-II Biomarker
Time frame: 2 Weeks
To evaluate the efficacy of NEM®+BIOCURC® versus placebo at reducing exercise-induced cartilage turnover in healthy men \& 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 18 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Kevin Ruff, Ph.D. study chair
ESM Technologies, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEM® + BIOCURC® in people with Exercise-induced Joint Pain and Exercise-induced Joint Stiffness, run by ESM Technologies, LLC at 1 site in United States.
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 8 inclusion and 11 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 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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 18 Jul 2019.