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

NCT ID: NCT03760757

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-11
• Study Completion Date: 2019-08-30

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).

Conditions

Inflammation; Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

PCSO-524® (no krill oil)

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).

Group Type: EXPERIMENTAL

PCSO-524®

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

ESPO-572®

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

ESPO-572®

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

Intervention Type: DIETARY_SUPPLEMENT

PCSO-524®

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.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tim Mickleborough

Professor, Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy D Mickleborough, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Indiana University School of Public Health

Bloomington, Indiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25722660 (View on PubMed)

Other Identifiers

1809579862

Identifier Type: -

Identifier Source: org_study_id