NEM® Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover In Healthy, Post-Menopausal Women
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|ClinicalTrials.gov Identifier: NCT02751944|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Exercise-induced Joint Pain Stiffness and Cartilage Turnover||Dietary Supplement: NEM Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: NEM Treatment
NEM, 500 mg, once daily, orally for 2 weeks
Dietary Supplement: NEM
Dietary supplement for the support of joint health.
Other Name: Natural Eggshell Membrane
Placebo Comparator: Placebo
Placebo, 500 mg, once daily, orally for 2 weeks
Dietary Supplement: Placebo
- 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.
- Exercise-induced Joint Pain via questionnaire [ Time Frame: 2 weeks ]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.
- Exercise-induced Joint Stiffness via questionnaire [ Time Frame: 2 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751944
|Principal Investigator:||Dennis Morrison, D.O.||QPS-Biokinetic|
|Study Director:||Kevin J Ruff, Ph.D., MBA||ESM Technologies, LLC|