InflammationNCT04819646
Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
A study testing Marine Lipid Oil Concentrate Formulation and Dietary Supplement in people with Inflammation, run by Supplement Formulators, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Marine Lipid Oil Concentrate Formulation and Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 2 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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 -
Who cannot join
- 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
Show all 37Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lfie Extension Clinical Reseach, Inc.
Fort Lauderdale, Florida, 33308
About this study
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
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
Read the 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.
- Conditions
- Inflammation
- Being tested
- Marine Lipid Oil Concentrate Formulation, Dietary Supplement
- Keywords
- inflammation, Pain, Discomfort, Soreness
- Medical subject headings
- Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marine Lipid Oil Concentrate FormulationDietary supplement
Marine Lipid Oil Concentrate softgels
Dietary SupplementDietary supplement
Dietary Supplement capsules
| Study group | Role | What they receive |
|---|---|---|
| Inflammation | Experimental | Marine Lipid Oil concentrate softgel and dietary supplement capsule Receives: Dietary Supplement: Marine Lipid Oil Concentrate Formulation; Dietary Supplement: Dietary Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 (Short Form-36) Health Survey
Assessment of the mean change in the results from the SF-36 Health Survey from baseline
Measured: 60 days
Medical Symptoms Questionnaire
Assessment of the mean change in the results from the Medical Symptoms Questionnaire from baseline
Measured: 60 days
Pain Questionnaire
Assessment of the mean change in the results from the Pain Questionnaire from baseline
Measured: 60 days
Minor body discomfort, pain, or soreness
Assessment of the mean change in the frequency of minor body discomfort, pain, or soreness per week from baseline
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start7 Jan 2021
- Primary completion3 Sep 2021
- Study completion2 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supplement Formulators, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Swick, Ph.D, Principal investigator, Life Extension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819646
- Sponsor's protocol ID
- CL108
- Status last verified
- Jan 2023
- First submitted
- 24 Mar 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aggarwal BB, Gupta SC, Sung B. Curcumin: an orally bioavailable blocker of TNF and other pro-inflammatory biomarkers. Br J Pharmacol. 2013 Aug;169(8):1672-92. doi: 10.1111/bph.12131.
PubMed 23425071Bassiouny AR, Zaky A, Kandeel KM. Alteration of AP-endonuclease1 expression in curcumin-treated fibrotic rats. Ann Hepatol. 2011 Oct-Dec;10(4):516-30.
PubMed 21911894Buhrmann 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.
PubMed 21669872Campbell, M., Berrones, A., Krishnakumar, I. M., Charnigo, R. J., Westgate, P. M., & Fleenor, B. S. (2017). Responsiveness to curcumin intervention is associated with reduced aortic stiffness in young, obese men with higher initial stiffness. J Funct Foods, 29, 154-160.
Campbell MS, Ouyang A, I M K, Charnigo RJ, Westgate PM, Fleenor BS. Influence of enhanced bioavailable curcumin on obesity-associated cardiovascular disease risk factors and arterial function: A double-blinded, randomized, controlled trial. Nutrition. 2019 Jun;62:135-139. doi: 10.1016/j.nut.2019.01.002. Epub 2019 Jan 11.
PubMed 30889454Chainani-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.
PubMed 21907450Chen 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.
PubMed 26471308Doyle 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.
PubMed 30293857Fiala 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.
PubMed 26401996Hewlings SJ, Kalman DS. Curcumin: A Review of Its Effects on Human Health. Foods. 2017 Oct 22;6(10):92. doi: 10.3390/foods6100092.
PubMed 29065496Krishnakumar, 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.
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.
PubMed 30345312Kumar, 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.
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.
PubMed 25987424Madhu K, Chanda K, Saji MJ. Safety and efficacy of Curcuma longa extract in the treatment of painful knee osteoarthritis: a randomized placebo-controlled trial. Inflammopharmacology. 2013 Apr;21(2):129-36. doi: 10.1007/s10787-012-0163-3. Epub 2012 Dec 16.
PubMed 23242572
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04819646
- Acronym / sponsor ID
- CL108
- Conditions
- Inflammation
- Keywords
- inflammation, Pain, Discomfort, Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 2 Nov 2021 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammation | Experimental | Dietary Supplement: Marine Lipid Oil Concentrate Formulation, Dietary Supplement: Dietary SupplementMarine Lipid Oil concentrate softgel and dietary supplement capsule |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marine Lipid Oil Concentrate FormulationMarine Lipid Oil Concentrate softgels | Dietary supplement | Inflammation |
| Dietary SupplementDietary Supplement capsules | Dietary supplement | Inflammation |
Primary outcome
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
Medical Symptoms Questionnaire
Time frame: 60 days
Assessment of the mean change in the results from the Medical Symptoms Questionnaire from baseline
Pain Questionnaire
Time frame: 60 days
Assessment of the mean change in the results from the Pain Questionnaire from baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Background: PubMed 23425071Aggarwal BB, Gupta SC, Sung B. Curcumin: an orally bioavailable blocker of TNF and other pro-inflammatory biomarkers. Br J Pharmacol. 2013 Aug;169(8):1672-92. doi: 10.1111/bph.12131.
- Background: PubMed 21911894Bassiouny AR, Zaky A, Kandeel KM. Alteration of AP-endonuclease1 expression in curcumin-treated fibrotic rats. Ann Hepatol. 2011 Oct-Dec;10(4):516-30.
- Background: PubMed 21669872Buhrmann 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.
- BackgroundCampbell, M., Berrones, A., Krishnakumar, I. M., Charnigo, R. J., Westgate, P. M., & Fleenor, B. S. (2017). Responsiveness to curcumin intervention is associated with reduced aortic stiffness in young, obese men with higher initial stiffness. J Funct Foods, 29, 154-160.
- Background: PubMed 30889454Campbell MS, Ouyang A, I M K, Charnigo RJ, Westgate PM, Fleenor BS. Influence of enhanced bioavailable curcumin on obesity-associated cardiovascular disease risk factors and arterial function: A double-blinded, randomized, controlled trial. Nutrition. 2019 Jun;62:135-139. doi: 10.1016/j.nut.2019.01.002. Epub 2019 Jan 11.
- Background: PubMed 21907450Chainani-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.
- Background: PubMed 26471308Chen 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.
- Background: PubMed 30293857Doyle 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.
- Background: PubMed 26401996Fiala 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.
- Background: PubMed 29065496Hewlings SJ, Kalman DS. Curcumin: A Review of Its Effects on Human Health. Foods. 2017 Oct 22;6(10):92. doi: 10.3390/foods6100092.
- BackgroundKrishnakumar, 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.
- Background: PubMed 30345312T 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Swick, Ph.D principal investigator
Life Extension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marine Lipid Oil Concentrate Formulation and Dietary Supplement in people with Inflammation, run by Supplement Formulators, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 (Short Form-36) Health Survey (time frame: 60 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04819646, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.