Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
The purpose of the study is to assess the efficacy and safety of a Marine Lipid Oil
 Concentrate formulation on inflammation/discomfort and overall well-being in male and female
 subjects who are generally healthy
This is an open-label, single-arm remote study to evaluate the effects of a Marine Lipid Oil
 Concentrate formulation on inflammation/discomfort and overall well-being in individuals who
 are generally healthy. Each subject will receive a specific dose of the study products to be
 taken once daily for a total of 60 days.

 Participants complete assessments and questionnaires.

 The primary objective is the evaluation of the change in the responses to the SF-36
 (Short-Form-36) Health Survey, Medical Symptoms questionnaire, Pain questionnaire and
 responses on an assessment form relative to baseline.

 Safety and tolerability will be evaluated through receipt of documentation and responses from
 the telephone contacts/emails as per protocol.
Inclusion Criteria:

 1. Ambulatory, male or female, 35-75 years of age

 2. Indicating "very mild," "mild, "or "moderate" for question #7 on the SF-36 Health
 Survey (How much bodily pain have you had during the past 4 weeks?)

 3. Have had minor body discomfort, pain, or soreness occurring at least four times per
 week during the past 4 weeks including symptoms felt when arising in the morning, at
 the end of a day, during or after physical activity

 4. Have personal access and able to operate a smartphone, tablet, or computer with enough
 memory to accommodate additional application(s) and have a reliable internet service

 5. Able to print out and return documents by scan, email or by mail

 6. Generally healthy and having no significant difficulty with digestion or absorption of
 food

 7. Able to complete an Activity Log and Study Product Log daily

 8. Has been generally weight stable for the past six months (+/- 6 lbs.)

 9. Willing and able to give written informed consent

 10. Clearly understands the procedures and study requirements

 11. Willing and able to comply with all study procedures, including following
 recommendations to maintain their usual diet and regular activity, as per protocol

 12. Able to communicate, including reading, in English

 13. Has not taken any nutritional supplements that may contain any of the components of
 the study products for a minimum of 14 days before Screening/baseline and for the
 duration of the study period -

 Exclusion Criteria:

 1. Not having basic skills needed to operate a smartphone, tablet, or computer

 2. Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational
 drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol
 (THC) in the past 30 days

 3. Having donated blood within 30 days before Screening/baseline

 4. Having been diagnosed with dysphagia or difficulty swallowing

 5. Having participated in another study within 30 days prior to Screening/baseline

 6. Being pregnant or planning on becoming pregnant during study participation; or breast
 feeding

 7. History of allergy or sensitivity to any component of the study products

 8. Having taken a lipid lowering medication (including statin medications) on a
 consistent basis for > 3 months and have muscle-related pain and/or anticipate a
 change in the medication during the study period

 9. Currently taking a medication or dietary supplement specifically for pain or
 inflammation, including curcumin, and unwilling to washout (i.e., stop taking
 medication or supplement) for 14 days before Screening/baseline

 10. Currently taking or having taken a fish oil, krill oil, omega-3 supplement and omega-3
 prescription drugs within the past 3 months before Screening/baseline which, in the
 judgment of the Study Investigator/Sub-Investigator, would preclude participation in
 study

 11. Currently taking or having taken pain medications or anti-inflammatory medication(s)
 (e.g., aspirin > 325 mg, non-steroidal anti-inflammatory drugs [NSAIDs], COX-2
 (Cyclooxygenase-2) inhibitors, and corticosteroids) within 14 days before
 Screening/baseline which, in the judgment of the Study Investigator/Sub-Investigator
 would preclude participation in the study

 12. Having been diagnosed, received medical treatment, or taking medication daily for the
 following medical condition(s):

 -  Acute or chronic inflammatory or autoimmune disease (including rheumatoid
 arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren's
 syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic
 arthritis)

 -  Active infection

 -  Active periodontal disease

 13. Having been in an accident or had surgery with resulting body discomfort, pain, or
 soreness

 14. Having been diagnosed with a pain-related disorder or under the care of a pain
 specialist

 15. Presence of active or recurring clinically significant conditions as follows:

 -  Diabetes mellitus or other endocrine disease

 -  Eating disorder

 -  Cardiovascular disease including heart and blood vessel disease, arrhythmia,
 heart attack, stroke, or heart valve problem

 -  Gastrointestinal disease including gallbladder problems, gallstones, or biliary
 tract obstruction

 -  Thyroid disease (unless on a stable dose of medication for ≥ 3 months before
 Screening/baseline and unlikely to change medication or dose during the study)

 -  Hypertension (unless on a stable dose of medication for ≥ 3 months before
 Screening/baseline and unlikely to change medication or dose during the study)

 -  Neurologic condition/disease

 -  Cancer (unless skin cancer other than melanoma which has been treated ≥ 3 years
 before Screening/baseline)

 -  Liver, pancreatic, and kidney disease

 -  Pulmonary disease

 -  Blood coagulation disorder or other hematologic disease

 -  Other condition or medication use that would preclude participation in the study
 in the judgment of the Study Investigator/Sub-Investigator

 16. Currently taking any medication or treatment for a psychiatric disorder (bipolar
 disorder, manic disorder, schizophrenia, apathetic [inherited] disorder), that include
 antidepressant drugs, including selective serotonin reuptake inhibitors (SSRIs),
 tricyclic and atypical antidepressants; benzodiazepines; phenothiazines, central
 nervous system (CNS) depressants as well as the following medications:
 dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs), pentazocine and
 tramadol. These may preclude participation in the study dependent on the judgment of
 the Study Investigator/Sub-Investigator.

 17. Currently taking or having taken within the 30 days before Screening/baseline any
 hormone replacement therapy (including DHEA (dehydroepiandrosterone), estrogen,
 progesterone, or testosterone), except those utilized as a method of birth control and
 which have been taken for > 3 months with no anticipated change for the duration of
 the study period

 18. Having had a surgical procedure or having an internal medical device which, in the
 judgment of the Study Investigator/Sub-Investigator, would preclude participation in
 the study

 19. Currently consumes more than 7 standard alcoholic drinks per week for women and 4
 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of
 beer, one glass of wine, or one ounce of hard liquor)

 20. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville
 oranges, and tangelos for the duration of the study period

 21. History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines
 or amphetamines)

 22. Having any other circumstance that precludes study participation in the judgment of
 the Study Investigator/Sub-Investigator, including use of other nutritional
 supplements, which will be evaluated on a case-by-case basis