NCT03679923

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: ESM Technologies, LLC · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NEM® brand eggshell membrane	Dietary supplement for the support of joint health.
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2018-09-20
• Primary completion: 2018-11-13
• Completion: 2018-11-13
• First posted: 2018-09-21
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States