Clinical trial NCT03760757: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation; Muscle
Keywords: krill oil
DOMS
EIMD (exercise induced muscle damage)
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 57
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled non-inferiority trial
Primary purpose: BASIC_SCIENCE

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).

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)

Primary outcomes:
measure: Creatine Kinase
timeFrame: Four days
measure: Skeletal muscle slow troponin I
timeFrame: Four days
measure: Interleukin-1 Beta
timeFrame: Four days
measure: Tumor necrosis factor-alpha
timeFrame: Four days
measure: Isometric torque
timeFrame: Four days
measure: Range of motion
timeFrame: Four days
measure: Swelling
timeFrame: Four days
measure: Delayed onset muscle soreness
timeFrame: Four days
measure: Pressure pain threshold
timeFrame: Four days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University School of Public Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Timothy D Mickleborough, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.