Inflammation; MuscleNCT03760757
Effectiveness of Two Different Forms of Marine Oil on Indirect Markers of Muscle Damage and Soreness in Untrained Men
A study testing ESPO-572® and PCSO-524® in people with Inflammation; Muscle, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation; Muscle
- What is being tested?
- ESPO-572® and PCSO-524®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2019to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University School of Public Health
Bloomington, Indiana, 47405
About this study
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
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.
Read the 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
- Being tested
- ESPO-572®, PCSO-524®
- Keywords
- krill oil, DOMS, EIMD (exercise induced muscle damage)
- Medical subject headings
- Myositis, Inclusion Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPO-572®Dietary supplement
ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Dietary Supplement: ESPO-572® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four days
Skeletal muscle slow troponin I
Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO).
Units: ng/mL
Measured: 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
Measured: 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
Measured: 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
Measured: Four days
Range of motion
Measurement of knee flexion range of motion
Units: degrees
Measured: Four days
Swelling
Limb girth measurements are used to test for the presence of swelling/edema within a muscle.
Units: percentage change from baseline
Measured: 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
Measured: 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
Measured: Four days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start11 Feb 2019
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammation; MuscleStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled non-inferiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Mickleborough, Indiana University
- Investigators
- Timothy D Mickleborough, Ph.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760757
- Sponsor's protocol ID
- 1809579862
- Status last verified
- Jul 2020
- First submitted
- 7 Nov 2018
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25722660
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03760757
- Acronym / sponsor ID
- 1809579862
- Conditions
- Inflammation; Muscle
- Keywords
- krill oil, DOMS, EIMD (exercise induced muscle damage)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| PCSO-524® (no krill oil) | Experimental | Dietary Supplement: 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). |
| ESPO-572® (75% PCSO-524®, 25% krill oil) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPO-572®ESPO-572® is the same as PCSO-524®, except it has krill oil added to it. | Dietary supplement | ESPO-572® (75% PCSO-524®, 25% krill oil) |
| 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. | Dietary supplement | PCSO-524® (no krill oil) |
Primary outcome
Creatine Kinase
Time frame: 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
Skeletal muscle slow troponin I
Time frame: Four days
Muscle damage markers: Skeletal muscle slow troponin I, (Novus Biologicals LLc., Littleton, CO). Units: ng/mL
Interleukin-1 Beta
Time frame: Four days
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
Time frame: 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
Isometric torque
Time frame: 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
Range of motion
Time frame: Four days
Measurement of knee flexion range of motion Units: degrees
Swelling
Time frame: Four days
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
Time frame: 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
Pressure pain threshold
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 25722660Mickleborough 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy D Mickleborough, Ph.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPO-572® and PCSO-524® in people with Inflammation; Muscle, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creatine Kinase (time frame: Four days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03760757, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.