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

Not Applicable

Completed

• Conditions: Inflammation; Muscle
• Interventions: Dietary Supplement: ESPO-572®; Dietary Supplement: PCSO-524®

• Registration Number: NCT03760757
• Lead Sponsor: Indiana University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2019-02-11
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 57

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESPO-572® (75% PCSO-524®, 25% krill oil)	ESPO-572®	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.
PCSO-524® (no krill oil)	PCSO-524®	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).

Primary Outcome Measures

Name	Time	Method
Creatine Kinase	Four days	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
Pressure pain threshold	Four days	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
Isometric torque	Four days	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
Tumor necrosis factor-alpha	Four days	Muscle inflammation markers: Tumor necrosis factor-alpha (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA).; Units: pg/mL
Delayed onset muscle soreness	Four days	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
Range of motion	Four days	Measurement of knee flexion range of motion; Units: degrees
Swelling	Four days	Limb girth measurements are used to test for the presence of swelling/edema within a muscle.; Units: percentage change from baseline
Skeletal muscle slow troponin I	Four days	Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO).; Units: ng/mL
Interleukin-1 Beta	Four days	Muscle inflammation markers: Interleukin-1 Beta (Cayman Chemicals, Ann Arbor, MI) will be analyzed using enzyme-linked immunoassay (ELISA).; Units: pg/mL

Trial Locations

Locations (1)

Indiana University School of Public Health; 🇺🇸 Bloomington, Indiana, United States