Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
NCT ID: NCT04819646
Last Updated: 2023-01-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
31 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-07
Study Completion Date
2021-11-02
Brief Summary
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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
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Detailed Description
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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.
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.
Conditions
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Inflammation
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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Inflammation
Marine Lipid Oil concentrate softgel and dietary supplement capsule
Group Type
EXPERIMENTAL
Marine Lipid Oil Concentrate Formulation
Intervention Type
DIETARY_SUPPLEMENT
Marine Lipid Oil Concentrate softgels
Dietary Supplement
Intervention Type
DIETARY_SUPPLEMENT
Dietary Supplement capsules
Interventions
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Marine Lipid Oil Concentrate Formulation
Marine Lipid Oil Concentrate softgels
Intervention Type
DIETARY_SUPPLEMENT
Dietary Supplement
Dietary Supplement capsules
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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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 -
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
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
Minimum Eligible Age
35 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Supplement Formulators, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Andrew Swick, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Life Extension
Locations
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Lfie Extension Clinical Reseach, Inc.
Fort Lauderdale, Florida, United States
Site Status
Countries
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United States
References
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Buhrmann C, Mobasheri A, Busch F, Aldinger C, Stahlmann R, Montaseri A, Shakibaei M. Curcumin modulates nuclear factor kappaB (NF-kappaB)-mediated inflammation in human tenocytes in vitro: role of the phosphatidylinositol 3-kinase/Akt pathway. J Biol Chem. 2011 Aug 12;286(32):28556-66. doi: 10.1074/jbc.M111.256180. Epub 2011 Jun 13.
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Chainani-Wu N, Madden E, Lozada-Nur F, Silverman S Jr. High-dose curcuminoids are efficacious in the reduction in symptoms and signs of oral lichen planus. J Am Acad Dermatol. 2012 May;66(5):752-60. doi: 10.1016/j.jaad.2011.04.022. Epub 2011 Sep 9.
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Chen FY, Zhou J, Guo N, Ma WG, Huang X, Wang H, Yuan ZY. Curcumin retunes cholesterol transport homeostasis and inflammation response in M1 macrophage to prevent atherosclerosis. Biochem Biophys Res Commun. 2015 Nov 27;467(4):872-8. doi: 10.1016/j.bbrc.2015.10.051. Epub 2015 Oct 19.
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Doyle R, Sadlier DM, Godson C. Pro-resolving lipid mediators: Agents of anti-ageing? Semin Immunol. 2018 Dec;40:36-48. doi: 10.1016/j.smim.2018.09.002. Epub 2018 Oct 4.
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Fiala M, Terrando N, Dalli J. Specialized Pro-Resolving Mediators from Omega-3 Fatty Acids Improve Amyloid-beta Phagocytosis and Regulate Inflammation in Patients with Minor Cognitive Impairment. J Alzheimers Dis. 2015;48(2):293-301. doi: 10.3233/JAD-150367.
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Hewlings SJ, Kalman DS. Curcumin: A Review of Its Effects on Human Health. Foods. 2017 Oct 22;6(10):92. doi: 10.3390/foods6100092.
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Krishnakumar, I. M., Abhilash, M., Gopakumar, G., Dinesh, K., Balu, M., & Ramadasan, K. (2015). Improved blood-brain-barrier permeability and tissue distribution following the oral administration of a food-grade formulation of curcumin with fenugreek fibre. J Funct Foods, 14, 215-225.
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T Krishnareddy N, Thomas JV, Nair SS, N Mulakal J, Maliakel BP, Krishnakumar IM. A Novel Curcumin-Galactomannoside Complex Delivery System Improves Hepatic Function Markers in Chronic Alcoholics: A Double-Blinded, randomized, Placebo-Controlled Study. Biomed Res Int. 2018 Sep 23;2018:9159281. doi: 10.1155/2018/9159281. eCollection 2018.
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Kumar, D., Jacob, D., Subash, P. S., Abhilash, M., Johannah, N. M., Ramadassan, K., . Krishnakumar, I. M. (2016). Enhanced bioavailability and relative distribution of free (unconjugated) curcuminoids following the oral administration of a food-grade formulation with fenugreek dietary fibre: A randomised double-blind crossover study. J Funct Foods, 22, 578 - 587.
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Lopez-Vicario C, Rius B, Alcaraz-Quiles J, Garcia-Alonso V, Lopategi A, Titos E, Claria J. Pro-resolving mediators produced from EPA and DHA: Overview of the pathways involved and their mechanisms in metabolic syndrome and related liver diseases. Eur J Pharmacol. 2016 Aug 15;785:133-143. doi: 10.1016/j.ejphar.2015.03.092. Epub 2015 May 15.
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Mehra MR, Lavie CJ, Ventura HO, Milani RV. Fish oils produce anti-inflammatory effects and improve body weight in severe heart failure. J Heart Lung Transplant. 2006 Jul;25(7):834-8. doi: 10.1016/j.healun.2006.03.005. Epub 2006 May 24.
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Norris PC, Skulas-Ray AC, Riley I, Richter CK, Kris-Etherton PM, Jensen GL, Serhan CN, Maddipati KR. Identification of specialized pro-resolving mediator clusters from healthy adults after intravenous low-dose endotoxin and omega-3 supplementation: a methodological validation. Sci Rep. 2018 Dec 21;8(1):18050. doi: 10.1038/s41598-018-36679-4.
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Panahi Y, Hosseini MS, Khalili N, Naimi E, Simental-Mendia LE, Majeed M, Sahebkar A. Effects of curcumin on serum cytokine concentrations in subjects with metabolic syndrome: A post-hoc analysis of a randomized controlled trial. Biomed Pharmacother. 2016 Aug;82:578-82. doi: 10.1016/j.biopha.2016.05.037. Epub 2016 Jun 6.
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Saji S, Asha S, Svenia PJ, Ratheesh M, Sheethal S, Sandya S, Krishnakumar IM. Curcumin-galactomannoside complex inhibits pathogenesis in Ox-LDL-challenged human peripheral blood mononuclear cells. Inflammopharmacology. 2018 Oct;26(5):1273-1282. doi: 10.1007/s10787-018-0474-0. Epub 2018 Apr 9.
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So J, Wu D, Lichtenstein AH, Tai AK, Matthan NR, Maddipati KR, Lamon-Fava S. EPA and DHA differentially modulate monocyte inflammatory response in subjects with chronic inflammation in part via plasma specialized pro-resolving lipid mediators: A randomized, double-blind, crossover study. Atherosclerosis. 2021 Jan;316:90-98. doi: 10.1016/j.atherosclerosis.2020.11.018. Epub 2020 Dec 7.
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Spite M, Claria J, Serhan CN. Resolvins, specialized proresolving lipid mediators, and their potential roles in metabolic diseases. Cell Metab. 2014 Jan 7;19(1):21-36. doi: 10.1016/j.cmet.2013.10.006. Epub 2013 Nov 14.
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Wongcharoen W, Jai-Aue S, Phrommintikul A, Nawarawong W, Woragidpoonpol S, Tepsuwan T, Sukonthasarn A, Apaijai N, Chattipakorn N. Effects of curcuminoids on frequency of acute myocardial infarction after coronary artery bypass grafting. Am J Cardiol. 2012 Jul 1;110(1):40-4. doi: 10.1016/j.amjcard.2012.02.043. Epub 2012 Apr 3.
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Reference Type
BACKGROUND
Other Identifiers
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CL108
Identifier Type: -
Identifier Source: org_study_id
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