Clinical trial NCT04819646: Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: inflammation
Pain
Discomfort
Soreness
Lead sponsor: Supplement Formulators, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: SF-36 (Short Form-36) Health Survey
timeFrame: 60 days
measure: Medical Symptoms Questionnaire
timeFrame: 60 days
measure: Pain Questionnaire
timeFrame: 60 days
measure: Minor body discomfort, pain, or soreness
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Lfie Extension Clinical Reseach, Inc.
state: Florida
Study officials:
affiliation: Life Extension
name: Andrew Swick, Ph.D
role: PRINCIPAL_INVESTIGATOR
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