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

January 12, 2023 updated by: Supplement Formulators, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Lfie Extension Clinical Reseach, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ambulatory, male or female, 35-75 years of age
  2. A BMI of 23-34.9
  3. hs-CRP level of 1-7.5 mg/L
  4. Generally healthy and having no significant difficulty with digestion or absorption of food
  5. Has been generally weight stable for the past six months (+/- 6 lbs.)
  6. Willing and able to give written informed consent
  7. Clearly understands the procedures and study requirements
  8. Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
  9. Able to communicate, including reading, in English
  10. 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:

  1. 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.
  2. Donated blood within 30 days before Screening/baseline
  3. Inability to provide a venous blood sample
  4. Participation in another study within 30 days before Screening/baseline
  5. Being pregnant or planning on becoming pregnant during study participation; or breast feeding
  6. History of allergy or sensitivity to any component of the study products
  7. Currently taking a lipid lowering medication or dietary supplement
  8. 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
  9. 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
  10. 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

  11. 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)

  12. 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
  13. 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.
  14. 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)
  15. 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
  16. 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
  17. 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
  18. 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)
  19. Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges, and tangelos
  20. History of known or suspected substance abuse (e.g., alcohol, opiates, benzodiazepines or amphetamines).
  21. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

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
Time Frame: 60 days
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
Time Frame: 60 days
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
Time Frame: 60 days
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
Time Frame: 60 days
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
Time Frame: 60 days
Mean or median change in Fibrinogen Activity from baseline to Day 60
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supplement Formulators, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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