Status:
COMPLETED
Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
Lead Sponsor:
Supplement Formulators, Inc.
Conditions:
Inflammation
Eligibility:
All Genders
35-75 years
Phase:
NA
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 genera...
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 ...
Eligibility Criteria
Inclusion
- Ambulatory, male or female, 35-75 years of age
- 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?)
- 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
- 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
- Able to print out and return documents by scan, email or by mail
- Generally healthy and having no significant difficulty with digestion or absorption of food
- Able to complete an Activity Log and Study Product Log daily
- 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 recommendations to maintain their usual diet and regular activity, as per protocol
- Able to communicate, including reading, in English
- 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
- 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):
- 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
- 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:
- 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
- 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
Key Trial Info
Start Date :
January 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04819646
Start Date
January 7 2021
End Date
November 2 2021
Last Update
January 13 2023
Active Locations (1)
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1
Lfie Extension Clinical Reseach, Inc.
Fort Lauderdale, Florida, United States, 33308