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Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men

Primary Purpose

Inflammation; Muscle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ESPO-572®
PCSO-524®
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation; Muscle focused on measuring krill oil, DOMS, EIMD (exercise induced muscle damage)

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects will include males (18 to 30 years), determined to be low risk (as determined by ACSM's Guidelines for Exercise Testing and Prescription (American College of Sports Medicine., Thompson, Gordon, & Pescatello, 2010)
  • BMI<30 (not obese) by a modified physical activity readiness questionnaire (PAR-Q),
  • Classified as 'untrained' defined by not habitually exercising more than 3x/week. In order to participate subjects would be allowed to exercise not more than three days a week. Each of the exercise sessions must not be longer than 30 minutes and cannot include downhill or uphill running.

Exclusion Criteria:

  • History of asthma or exercise-induced asthma, COPD, interstitial lung diseases, or cystic fibrosis, dyspnea
  • History of downhill running training or other eccentric endurance exercise within the past 3 months
  • History of fish oil or other omega-3 nutritional supplements within the last 3 months
  • History of significant pain in hips or knees
  • Current participation in a strength training program or having participated in a strength training program within 60 days before the study
  • Regular use of anti-inflammatory medication or nutritional supplements (e.g. ketorolac, celecoxib, creatine, protein drinks, amino acids, fish oil or vitamins)
  • Current daily use of anti-inflammatory medication such as Tylenol, Advil, or Aleve.
  • Allergies to fish, seafood, or shellfish
  • Family or personal history of cardiac, peripheral vascular, or cerebrovascular disease.
  • A diabetic or experience shortness of breath as determined by the modified PAR_Q.
  • In addition to screening subjects for known cardiovascular disease, or signs and symptoms of pulmonary metabolic disease, subjects will be excluded if their values are outside ACSM's guidelines for cardiovascular disease risk as outlined in Figure 2. This would place subjects as low risk. Researchers will be screening based on age, family history of heart attacks, exposure to cigarette smoke, obesity, hypertension, dyslipidemia and pre-diabetes. Since subjects are recruited as sedentary, this a positive risk factor for CVD. Subjects will be screened for dyslipidemia and will be accepted into the study if their values are for low-density lipoprotein (LDL-C) cholesterol less than 130 mg dL-1 (3.37 mmol·L-1) or a total serum cholesterol value of less than 200 mg·dL-1 (5.18mmol L-1) or and HCL-C is greater or equal to 40 mg·dL-1 (1.55mmol L-1). Please note that this will not change the subjects risk status and they will be still classified as low risk. Subjects should not be currently taking and cholesterol lowering medication such as: Atorvastatin (Lipitor), Fluvastatin (Lescol), Lovastatin (Mevacor), Pravastatin (Pravachol), Simvastatin (Zocor), Rosuvastatin (Crestor)

Sites / Locations

  • Indiana University School of Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PCSO-524® (no krill oil)

ESPO-572® (75% PCSO-524®, 25% krill oil)

Arm Description

Four total capsules per day (2 in the morning; 2 at night) for 29 days. Amounts per day equal to 800 mg olive oil, 400 mg lipid extract (~58 mg EPA and 44 mg DHA) and 1.8 mg vitamin E (d-alpha-tocopherol).

Four total capsules per day (2 in the morning; 2 at night) for 29 days. ESPO-572®, a 75/25% PCSO-24®/Krill oil blend. Each capsule of the ESPO-572® contains green lipped mussel oil, krill oil, olive oil and vitamin E.

Outcomes

Primary Outcome Measures

Creatine Kinase
Muscle damage markers: Muscle creatine kinase will be measured using a Beckman DU® Spectrophotometer (Beckman Coulter Inc., Brea, CA) at 360nm using a fluorometric assay kit (Cayman Chemicals, Ann Arbor, MI). Units: ng/mL
Skeletal muscle slow troponin I
Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO). Units: ng/mL
Interleukin-1 Beta
Muscle inflammation markers: Interleukin-1 Beta (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA). Units: pg/mL
Tumor necrosis factor-alpha
Muscle inflammation markers: Tumor necrosis factor-alpha (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA). Units: pg/mL
Isometric torque
Isometric torque: Isometric torque assessment of the dominant leg extensors will be conducted at a knee angle of 80°flexion (measured by a goniometry) using a Cybex Isokinetic System (Medway, MA). Units: Nm
Range of motion
Measurement of knee flexion range of motion Units: degrees
Swelling
Limb girth measurements are used to test for the presence of swelling/edema within a muscle. Units: percentage change from baseline
Delayed onset muscle soreness
Visual analog scale of muscle soreness (delayed onset muscle soreness; DOMS) - Knee extensor soreness will be assessed using a visual analogue scale with "no soreness" indicated at one end (score 0) and "unbearably painful" at the other (score 10). Units: Arbitrary units
Pressure pain threshold
A hand-held pressure algometer (Algometer®, Somedic Sales, Hörby, Sweden) will be used to monitor pressure induced pain at five specific sites on the quadriceps. Pressure pain threshold units: percentage change from baseline

Secondary Outcome Measures

Full Information

First Posted
November 7, 2018
Last Updated
July 27, 2020
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT03760757
Brief Title
Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men
Official Title
Effectiveness of Two Different Forms of Marine Oil, Derived From the New Zealand Green Lipped Mussel and Krill Oil, on Indirect Markers of Muscle Damage and Soreness During Recovery From Muscle Damaging Exercise in Untrained Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effects of PCSO-524®, and a blend of PCSO-24® (75%) and krill oil (25%) (ESPO-572®), on indirect markers of muscle damage, inflammation and soreness during recovery from muscle damaging exercise in untrained men.
Detailed Description
The study will be conducted as a randomized, parallel group trial over 29 days. A total of 50 untrained male subjects will participate in this study. Subjects will be classified as 'untrained' if they exercise less than three times per week for less than 30 min during each session. Subjects will be randomly assigned to either a green-lipped mussel oil blend (PCSO-524® supplementation group, n = 25) or a 75/25% PCSO-24®/Krill oil blend group (ESPO-572® supplementation group, n = 25). Supplementation will begin 26 days before an eccentric exercise bout (downhill running, designed to induce muscle damage and continue for 3 days following the muscle damaging exercise bout).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation; Muscle
Keywords
krill oil, DOMS, EIMD (exercise induced muscle damage)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled non-inferiority trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCSO-524® (no krill oil)
Arm Type
Experimental
Arm Description
Four total capsules per day (2 in the morning; 2 at night) for 29 days. Amounts per day equal to 800 mg olive oil, 400 mg lipid extract (~58 mg EPA and 44 mg DHA) and 1.8 mg vitamin E (d-alpha-tocopherol).
Arm Title
ESPO-572® (75% PCSO-524®, 25% krill oil)
Arm Type
Experimental
Arm Description
Four total capsules per day (2 in the morning; 2 at night) for 29 days. ESPO-572®, a 75/25% PCSO-24®/Krill oil blend. Each capsule of the ESPO-572® contains green lipped mussel oil, krill oil, olive oil and vitamin E.
Intervention Type
Dietary Supplement
Intervention Name(s)
ESPO-572®
Intervention Description
ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.
Intervention Type
Dietary Supplement
Intervention Name(s)
PCSO-524®
Intervention Description
PCSO-524® (Lyprinol®/Omega XL®) is a nutritional supplement containing a patented extract of highly condensed form of stabilized marine lipids from the New Zealand green lipped mussel (Perna canaliculus) that is combined with olive oil and vitamin E. This marine oil lipid and omega-3 polyunsaturated fatty acid (PUFA) blend is a diverse mixture of sterol esters, sterols, polar lipids, triglycerides, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (split between the triacylglycerol and polar lipid classes), and free fatty acids.
Primary Outcome Measure Information:
Title
Creatine Kinase
Description
Muscle damage markers: Muscle creatine kinase will be measured using a Beckman DU® Spectrophotometer (Beckman Coulter Inc., Brea, CA) at 360nm using a fluorometric assay kit (Cayman Chemicals, Ann Arbor, MI). Units: ng/mL
Time Frame
Four days
Title
Skeletal muscle slow troponin I
Description
Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO). Units: ng/mL
Time Frame
Four days
Title
Interleukin-1 Beta
Description
Muscle inflammation markers: Interleukin-1 Beta (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA). Units: pg/mL
Time Frame
Four days
Title
Tumor necrosis factor-alpha
Description
Muscle inflammation markers: Tumor necrosis factor-alpha (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA). Units: pg/mL
Time Frame
Four days
Title
Isometric torque
Description
Isometric torque: Isometric torque assessment of the dominant leg extensors will be conducted at a knee angle of 80°flexion (measured by a goniometry) using a Cybex Isokinetic System (Medway, MA). Units: Nm
Time Frame
Four days
Title
Range of motion
Description
Measurement of knee flexion range of motion Units: degrees
Time Frame
Four days
Title
Swelling
Description
Limb girth measurements are used to test for the presence of swelling/edema within a muscle. Units: percentage change from baseline
Time Frame
Four days
Title
Delayed onset muscle soreness
Description
Visual analog scale of muscle soreness (delayed onset muscle soreness; DOMS) - Knee extensor soreness will be assessed using a visual analogue scale with "no soreness" indicated at one end (score 0) and "unbearably painful" at the other (score 10). Units: Arbitrary units
Time Frame
Four days
Title
Pressure pain threshold
Description
A hand-held pressure algometer (Algometer®, Somedic Sales, Hörby, Sweden) will be used to monitor pressure induced pain at five specific sites on the quadriceps. Pressure pain threshold units: percentage change from baseline
Time Frame
Four days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects will include males (18 to 30 years), determined to be low risk (as determined by ACSM's Guidelines for Exercise Testing and Prescription (American College of Sports Medicine., Thompson, Gordon, & Pescatello, 2010) BMI<30 (not obese) by a modified physical activity readiness questionnaire (PAR-Q), Classified as 'untrained' defined by not habitually exercising more than 3x/week. In order to participate subjects would be allowed to exercise not more than three days a week. Each of the exercise sessions must not be longer than 30 minutes and cannot include downhill or uphill running. Exclusion Criteria: History of asthma or exercise-induced asthma, COPD, interstitial lung diseases, or cystic fibrosis, dyspnea History of downhill running training or other eccentric endurance exercise within the past 3 months History of fish oil or other omega-3 nutritional supplements within the last 3 months History of significant pain in hips or knees Current participation in a strength training program or having participated in a strength training program within 60 days before the study Regular use of anti-inflammatory medication or nutritional supplements (e.g. ketorolac, celecoxib, creatine, protein drinks, amino acids, fish oil or vitamins) Current daily use of anti-inflammatory medication such as Tylenol, Advil, or Aleve. Allergies to fish, seafood, or shellfish Family or personal history of cardiac, peripheral vascular, or cerebrovascular disease. A diabetic or experience shortness of breath as determined by the modified PAR_Q. In addition to screening subjects for known cardiovascular disease, or signs and symptoms of pulmonary metabolic disease, subjects will be excluded if their values are outside ACSM's guidelines for cardiovascular disease risk as outlined in Figure 2. This would place subjects as low risk. Researchers will be screening based on age, family history of heart attacks, exposure to cigarette smoke, obesity, hypertension, dyslipidemia and pre-diabetes. Since subjects are recruited as sedentary, this a positive risk factor for CVD. Subjects will be screened for dyslipidemia and will be accepted into the study if their values are for low-density lipoprotein (LDL-C) cholesterol less than 130 mg dL-1 (3.37 mmol·L-1) or a total serum cholesterol value of less than 200 mg·dL-1 (5.18mmol L-1) or and HCL-C is greater or equal to 40 mg·dL-1 (1.55mmol L-1). Please note that this will not change the subjects risk status and they will be still classified as low risk. Subjects should not be currently taking and cholesterol lowering medication such as: Atorvastatin (Lipitor), Fluvastatin (Lescol), Lovastatin (Mevacor), Pravastatin (Pravachol), Simvastatin (Zocor), Rosuvastatin (Crestor)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy D Mickleborough, Ph.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Public Health
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25722660
Citation
Mickleborough TD, Sinex JA, Platt D, Chapman RF, Hirt M. The effects PCSO-524(R), a patented marine oil lipid and omega-3 PUFA blend derived from the New Zealand green lipped mussel (Perna canaliculus), on indirect markers of muscle damage and inflammation after muscle damaging exercise in untrained men: a randomized, placebo controlled trial. J Int Soc Sports Nutr. 2015 Feb 19;12:10. doi: 10.1186/s12970-015-0073-z. eCollection 2015.
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Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men

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