A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise generally healthy.

Detailed Description
-----------------
This is a double-blind randomized, placebo-controlled study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation.. Each subject will receive a specific dose of the study product (A) to be taken once daily with a specific dose of the study product (B) to be taken once daily for a total of 60 days. Participants will receive questionnaires, assessments, blood tests, vital signs and a body composition analysis. The primary objective is the assessment of the change in the blood levels of hs-CRP in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo. The secondary objective is the assessment of the change in the in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo for Interleukin-6 (IL-6), Tumor necrosis factor (TNF-alpha), Erythrocyte Sedimentation Rate (ESR), Fibrinogen Activity, B-type natriuretic peptide (BNP), Ferritin, Blood lipid levels (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides), Short Form-36 (SF-36) Health Survey scores and the Medical Symptoms Questionnaire

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Specialized Pro-Resolving Mediator Formulation on Inflammation in Individuals Who Are Overweight to Mildly Obese and Otherwise Generally Healthy

Conditions
-----------------
Inflammation, Inflammatory Response

Intervention / Treatment
-----------------
* Dietary Supplement: Marine Lipid Oil Concentrate
* Dietary Supplement: Dietary Supplement
* Dietary Supplement: Placebo
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory, male or female, 35-75 years of age A BMI of 23-34.9 hs-CRP level of 1-7.5 mg/L Generally healthy and having no significant difficulty with digestion or absorption of food Has been generally weight stable for the past six months (+/- 6 lbs.) Willing and able to give written informed consent Clearly understands the procedures and study requirements Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol Able to communicate, including reading, in English Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline Exclusion Criteria: Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days. Donated blood within 30 days before Screening/baseline Inability to provide a venous blood sample Participation in another study within 30 days before 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 Currently taking a lipid lowering medication or dietary supplement Currently taking a medication or dietary supplement specifically for pain or inflammation including curcumin and unwilling to washout (i.e., stop taking) 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 Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin, NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline or in the judgment of the Study Investigator/Sub-I would not preclude participation in the study 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, system lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis) Presence of active or recurring clinically significant conditions as follows: Diabetes mellitus or other endocrine disease Acute infection Active periodontal disease 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 and unlikely to change medication or dose during the study) Hypertension (unless on a stable dose of medication for 3 months screening 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 Investigator/Sub-I Currently taking any medications 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; central nervous system (CNS) depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines, and tramadol. These may preclude participation in the study dependent on the judgment of the Investigator/Sub-I. Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), 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) Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-I, would preclude participation in the study Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 110 mg/dL, hs-CRP < 1.0 mg/L or > 5 mg/L, or other lab test result(s) that would preclude study participation in the judgement of the Study Investigator/Sub-I Having blood pressure readings at Screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the Study Investigator/Sub-I Currently consumes more than 7 standard alcoholic drinks per week for women and 14 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 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-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Marine Lipid Oil concentrate<br>Dietary Supplement: Marine Lipid oil concentrate softgel and dietary supplement capsules | Dietary Supplement: Marine Lipid Oil Concentrate<br>* Marine Lipid Oil Concentrate softgels<br>Dietary Supplement: Dietary Supplement<br>* Dietary Supplement capsules<br>|
| Placebo Comparator: Placebo<br>Placebo softgels with Placebo capsules | Dietary Supplement: Placebo<br>* Placebo softgels<br>Dietary Supplement: Placebo<br>* Placebo capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline | Mean or median change in high sensitivity C-reactive protein (hs-CRP) from baseline to Day 60 | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mean or median change in Interleukin-6 (IL-6) relative to baseline | Mean or median change in IL-6 from baseline to Day 60 | 60 days | 
| Assessment of the mean or median change in Tumor Necrosis Factor-alpha (TNF-alpha) relative to baseline | Mean or median change in TNF-alpha from baseline to Day 60 | 60 days | 
| Assessment of the mean or median change in Erythrocyte Sedimentation Rate (ESR) relative to baseline | Mean or median change in ESR from baseline to Day 60 | 60 days | 
| Assessment of the mean or median change in Fibrinogen Activity relative to baseline | Mean or median change in Fibrinogen Activity from baseline to Day 60 | 60 days |