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

NCT03760757 | Completed

• 1 other identifier: 1809579862
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Muscle

Keywords

krill oil; DOMS; EIMD (exercise induced muscle damage)

Outcome Measures

Primary Outcomes (9)

• 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

  Four days

• Skeletal muscle slow troponin I

  Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO). Units: ng/mL

  Four days

• 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

  Four days

• 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

  Four days

• 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

  Four days

• Range of motion

  Measurement of knee flexion range of motion Units: degrees

  Four days

• Swelling

  Limb girth measurements are used to test for the presence of swelling/edema within a muscle. Units: percentage change from baseline

  Four days

• 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

  Four days

• 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

  Four days

Study Arms (2)

PCSO-524® (no krill oil)

EXPERIMENTAL

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).

Dietary Supplement: PCSO-524®

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

EXPERIMENTAL

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.

Dietary Supplement: ESPO-572®

Interventions

ESPO-572® DIETARY_SUPPLEMENT

ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.

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

PCSO-524® DIETARY_SUPPLEMENT

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.

PCSO-524® (no krill oil)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

Location

Related Publications (1)

• 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.

  PMID: 25722660 BACKGROUND

MeSH Terms

Conditions

Myositis, Inclusion Body

Interventions

PCSO-524

Condition Hierarchy (Ancestors)

Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Timothy D Mickleborough, Ph.D.

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Kinesiology

Model Details: Randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 30, 2018
• Study Start: February 11, 2019
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

US (1)