Effects of Eggshell Membrane and Curcumin Extract Supplementation, Separately or Combined, on Recovery From Intense Exercise
Effects of NEM® Brand Eggshell Membrane and curQ+® Brand Highly Absorbable Curcumin Supplementation, Alone or in Combination, on Recovery From Intense Exercise in Recreationally Active Men.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Richard B. Kreider, Ph.D.
- Phone Number: (979) 458-1498
- Email: rbkreider@tamu.edu
Study Contact Backup
- Name: Christopher Rasmussen, M.S.
- Phone Number: (979) 458-1498
- Email: crasmussen@tamu.edu
Study Locations
-
-
Texas
-
College Station, Texas, United States, 77843
- Recruiting
- Exercise & Sport Nutrition Lab - Texas A&M University
-
Contact:
- Richard B. Kreider, Ph.D.
- Phone Number: (979) 458-1498
- Email: rbkreider@tamu.edu
-
Contact:
- Christopher Rasmussen, M.S.
- Phone Number: (979) 458-1498
- Email: crasmussen@tamu.edu
-
Principal Investigator:
- Richard B. Kreider, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 40 at the time of consent.
- Healthy and recreationally active.
- Ability to comply with study procedures.
- Agree to refrain from alcohol intake and use of non-steroidal anti-inflammatory (NSAIDS), aspirin, and other over-the-counter pain medications for 48 hours prior to and after completion of each testing session.
Exclusion Criteria:
- No recent history of exercise training
- An orthopedic limitation that would prevent the ability to perform the exercise intervention.
- Participants who currently smoke cigarettes.
- Known allergies to eggs, sulfur, or curcumin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Active, EM
500 mg/day of NEM® brand eggshell membrane powder in a single #0 capsule.
|
500 mg/day of NEM® brand eggshell membrane powder in a single #0 capsule.
2,860 mg/day of coconut oil/polysorbate blend in a single 10 Oval softgel.
|
|
Experimental: Active, curc
2,860 mg/day of curQ+® brand highly absorbable curcumin in a single 10 Oval softgel.
|
2,860 mg/day of curQ+® brand highly absorbable curcumin in a single 10 Oval softgel.
500 mg/day of psyllium husk fiber powder in a single #0 capsule.
|
|
Placebo Comparator: Placebo
500 mg/day of psyllium husk fiber powder in a single #0 capsule PLUS 2,860 mg/day of coconut oil/polysorbate blend in a single 10 Oval softgel.
|
2,860 mg/day of coconut oil/polysorbate blend in a single 10 Oval softgel.
500 mg/day of psyllium husk fiber powder in a single #0 capsule.
|
|
Experimental: Active, EM+Curc
500 mg/day of NEM® brand eggshell membrane powder in a single #0 capsule PLUS 2,860 mg/day of curQ+® brand highly absorbable curcumin in a single 10 Oval softgel.
|
500 mg/day of NEM® brand eggshell membrane powder in a single #0 capsule PLUS 2,860 mg/day of curQ+® brand highly absorbable curcumin in a single 10 Oval softgel.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS Muscle Soreness Rating
Time Frame: 2 weeks
|
Changes in Visual Analog Scale (VAS) ratings of muscle soreness (rated from zero to 100 mm) from baseline following intense exercise.
The higher the rating, the more muscle soreness so negative changes in VAS would equate to improvement.
|
2 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary CTX-II
Time Frame: 2 weeks
|
Changes in urinary CTX-II biomarker from baseline following intense exercise.
|
2 weeks
|
|
Muscle Damage
Time Frame: 2 weeks
|
Changes in markers of muscle enzyme efflux/damage (CK, LDH) from baseline following intense exercise.
|
2 weeks
|
|
Exercise Performance
Time Frame: 2 weeks
|
Changes in exercise performance (strength, muscular endurance, peak aerobic capacity) from baseline following intense exercise.
|
2 weeks
|
|
Inflammation Biomarkers
Time Frame: 2 weeks
|
Changes in markers of inflammation (TNFα, interleukin (IL) cytokines (IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10) from baseline following intense exercise.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Director: Kevin J. Ruff, Ph.D., ESM Technologies, LLC
- Principal Investigator: Richard B. Kreider, Ph.D., Exercise & Sport Nutrition Lab, Texas A&M University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- STUDY2025-0899
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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