Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort

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

An Open-label, Single-arm Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort in Individuals Who Are Generally Healthy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

31

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. 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inflammation
Marine Lipid Oil concentrate softgel and dietary supplement capsule
Dietary supplement: Marine Lipid Oil Concentrate Formulation
Marine Lipid Oil Concentrate softgels
Dietary supplement: Dietary Supplement
Dietary Supplement capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 (Short Form-36) Health Survey
Time Frame: 60 days
Assessment of the mean change in the results from the SF-36 Health Survey from baseline
60 days
Medical Symptoms Questionnaire
Time Frame: 60 days
Assessment of the mean change in the results from the Medical Symptoms Questionnaire from baseline
60 days
Pain Questionnaire
Time Frame: 60 days
Assessment of the mean change in the results from the Pain Questionnaire from baseline
60 days
Minor body discomfort, pain, or soreness
Time Frame: 60 days
Assessment of the mean change in the frequency of minor body discomfort, pain, or soreness per week from baseline
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)

January 7, 2021

Primary Completion (Actual)

September 3, 2021

Study Completion (Actual)

November 2, 2021

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 29, 2021

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL108

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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