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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inflammation | Experimental | Marine Lipid Oil concentrate softgel and dietary supplement capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marine Lipid Oil Concentrate Formulation | Dietary Supplement | Marine Lipid Oil Concentrate softgels |
|
| Measure | Description | Time Frame |
|---|---|---|
| SF-36 (Short Form-36) Health Survey | Assessment of the mean change in the results from the SF-36 Health Survey from baseline | 60 days |
| Medical Symptoms Questionnaire | Assessment of the mean change in the results from the Medical Symptoms Questionnaire from baseline | 60 days |
| Pain Questionnaire | Assessment of the mean change in the results from the Pain Questionnaire from baseline | 60 days |
| Minor body discomfort, pain, or soreness | Assessment of the mean change in the frequency of minor body discomfort, pain, or soreness per week from baseline | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
Not having basic skills needed to operate a smartphone, tablet, or computer
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
Having donated blood within 30 days before Screening/baseline
Having been diagnosed with dysphagia or difficulty swallowing
Having participated in another study within 30 days prior to Screening/baseline
Being pregnant or planning on becoming pregnant during study participation; or breast feeding
History of allergy or sensitivity to any component of the study products
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
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
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
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
Having been diagnosed, received medical treatment, or taking medication daily for the following medical condition(s):
Having been in an accident or had surgery with resulting body discomfort, pain, or soreness
Having been diagnosed with a pain-related disorder or under the care of a pain specialist
Presence of active or recurring clinically significant conditions as follows:
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.
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
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
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)
Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos for the duration of the study period
History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines)
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
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Swick, Ph.D | Life Extension | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lfie Extension Clinical Reseach, Inc. | Fort Lauderdale | Florida | 33308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23425071 | Background | Aggarwal BB, Gupta SC, Sung B. Curcumin: an orally bioavailable blocker of TNF and other pro-inflammatory biomarkers. Br J Pharmacol. 2013 Aug;169(8):1672-92. doi: 10.1111/bph.12131. | |
| 21911894 | Background | Bassiouny AR, Zaky A, Kandeel KM. Alteration of AP-endonuclease1 expression in curcumin-treated fibrotic rats. Ann Hepatol. 2011 Oct-Dec;10(4):516-30. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement | Dietary Supplement | Dietary Supplement capsules |
|
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