InflammationNCT04269876
A Study to Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation
A study testing Marine Lipid Oil Concentrate and Dietary Supplement in people with Inflammation and Inflammatory Response, run by Supplement Formulators, Inc. at 1 site in United States.
Trial summary
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise 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, Inflammatory Response
- What is being tested?
- Marine Lipid Oil Concentrate and Dietary Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 30 Sep 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
- A BMI of 23-34.9
- hs-CRP level of 1-7.5 mg/L
- Generally healthy and having no significant difficulty with digestion or absorption of food
- Has been generally weight stable for the past six months (+/- 6 lbs.)
- Willing and able to give written informed consent
Show all 10Show fewer
- Clearly understands the procedures and study requirements
- Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol
- Able to communicate, including reading, in English
- Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days before Screening/baseline
Who cannot join
- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days.
- Donated blood within 30 days before Screening/baseline
- Inability to provide a venous blood sample
- Participation in another study within 30 days before 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
Show all 35Show fewer
- Currently taking a lipid lowering medication or dietary supplement
- Currently taking a medication or dietary supplement specifically for pain or inflammation including curcumin and unwilling to washout (i.e., stop taking) 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
- Currently taking or having taken pain medications or anti-inflammatory medication(s) (e.g., aspirin, NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, and corticosteroids) within 14 days before Screening/baseline or in the judgment of the Study Investigator/Sub-I would not 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, system lupus erythematosus, ankylosing spondylitis, Sjögren's syndrome, polymyalgia rheumatica, inflammatory bowel disease, and psoriatic arthritis)
- Presence of active or recurring clinically significant conditions as follows:
- Diabetes mellitus or other endocrine disease
- Acute infection
- Active periodontal disease
- 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 and unlikely to change medication or dose during the study)
- Hypertension (unless on a stable dose of medication for 3 months screening 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 Investigator/Sub-I
- Currently taking any medications 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; central nervous system (CNS) depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines, and tramadol. These may preclude participation in the study dependent on the judgment of the Investigator/Sub-I.
- Currently taking or having taken within the 30 days before Screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), 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)
- Having had a surgical procedure or having an internal medical device which, in the judgment of the Study Investigator/Sub-I, would preclude participation in the study
- Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 110 mg/dL, hs-CRP < 1.0 mg/L or > 5 mg/L, or other lab test result(s) that would preclude study participation in the judgement of the Study Investigator/Sub-I
- Having blood pressure readings at Screening/baseline > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the Study Investigator/Sub-I
- Currently consumes more than 7 standard alcoholic drinks per week for women and 14 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
- 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-I, 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: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Specialized Pro-Resolving Mediator Formulation on Inflammation in Individuals Who Are Overweight to Mildly Obese and Otherwise Generally Healthy
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise generally healthy.
Read the detailed description
This is a double-blind randomized, placebo-controlled study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation.. Each subject will receive a specific dose of the study product (A) to be taken once daily with a specific dose of the study product (B) to be taken once daily for a total of 60 days.
Participants will receive questionnaires, assessments, blood tests, vital signs and a body composition analysis.
The primary objective is the assessment of the change in the blood levels of hs-CRP in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo.
The secondary objective is the assessment of the change in the in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo for Interleukin-6 (IL-6), Tumor necrosis factor (TNF-alpha), Erythrocyte Sedimentation Rate (ESR), Fibrinogen Activity, B-type natriuretic peptide (BNP), Ferritin, Blood lipid levels (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides), Short Form-36 (SF-36) Health Survey scores and the Medical Symptoms Questionnaire
- Conditions
- Inflammation, Inflammatory Response
- Being tested
- Marine Lipid Oil Concentrate, Dietary Supplement, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marine Lipid Oil ConcentrateDietary supplement
Marine Lipid Oil Concentrate softgels
Dietary SupplementDietary supplement
Dietary Supplement capsules
PlaceboDietary supplement
Placebo softgels
PlaceboDietary supplement
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Marine Lipid Oil concentrate | Experimental | Dietary Supplement: Marine Lipid oil concentrate softgel and dietary supplement capsules Receives: Dietary Supplement: Marine Lipid Oil Concentrate; Dietary Supplement: Dietary Supplement |
| Placebo | Placebo comparator | Placebo softgels with Placebo capsules Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline
Mean or median change in high sensitivity C-reactive protein (hs-CRP) from baseline to Day 60
Measured: 60 days
Secondary outcomes (4)
Assessment of the mean or median change in Interleukin-6 (IL-6) relative to baseline
Mean or median change in IL-6 from baseline to Day 60
Measured: 60 days
Assessment of the mean or median change in Tumor Necrosis Factor-alpha (TNF-alpha) relative to baseline
Mean or median change in TNF-alpha from baseline to Day 60
Measured: 60 days
Assessment of the mean or median change in Erythrocyte Sedimentation Rate (ESR) relative to baseline
Mean or median change in ESR from baseline to Day 60
Measured: 60 days
Assessment of the mean or median change in Fibrinogen Activity relative to baseline
Mean or median change in Fibrinogen Activity from baseline to Day 60
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 posted17 Feb 2020
- Study start31 Oct 2019
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 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
- NCT04269876
- Sponsor's protocol ID
- CL103
- Status last verified
- Jul 2022
- First submitted
- 12 Feb 2020
- 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 26471308Dallal, G (2017). Randomization.com. Retrieved from http://www.randomization.com
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.
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. 2016;49(4):1191. doi: 10.3233/JAD-159008. No abstract available.
PubMed 26756328Hewlings 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, Abhilash, M., Gopakumar, G.,et al. 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. et al. (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 Funt 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 25987424
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
- A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Specialized Pro-Resolving Mediator Formulation on Inflammation in Individuals Who Are Overweight to Mildly Obese and Otherwise Generally Healthy
- ClinicalTrials.gov ID
- NCT04269876
- Acronym / sponsor ID
- CL103
- Conditions
- Inflammation, Inflammatory Response
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Supplement Formulators, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 17 Feb 2020 (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.
To assess the efficacy and safety of a Marine Lipid Oil Concentrate formulation on inflammatory biomarkers and overall well-being in male and female subjects who are overweight to mildly obese, but otherwise generally healthy.
Detailed description
This is a double-blind randomized, placebo-controlled study to evaluate the effects of a Marine Lipid Oil Concentrate formulation on inflammation.. Each subject will receive a specific dose of the study product (A) to be taken once daily with a specific dose of the study product (B) to be taken once daily for a total of 60 days.
Participants will receive questionnaires, assessments, blood tests, vital signs and a body composition analysis.
The primary objective is the assessment of the change in the blood levels of hs-CRP in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo.
The secondary objective is the assessment of the change in the in response to the Marine Lipid Oil Concentrate formulation relative to screening/baseline compared to placebo for Interleukin-6 (IL-6), Tumor necrosis factor (TNF-alpha), Erythrocyte Sedimentation Rate (ESR), Fibrinogen Activity, B-type natriuretic peptide (BNP), Ferritin, Blood lipid levels (Total Cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides), Short Form-36 (SF-36) Health Survey scores and the Medical Symptoms Questionnaire
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marine Lipid Oil concentrate | Experimental | Dietary Supplement: Marine Lipid Oil Concentrate, Dietary Supplement: Dietary SupplementDietary Supplement: Marine Lipid oil concentrate softgel and dietary supplement capsules |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo softgels with Placebo capsules |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ambulatory, male or female, 35-75 years of age
- A BMI of 23-34.9
- hs-CRP level of 1-7.5 mg/L
- Generally healthy and having no significant difficulty with digestion or absorption of food
- Has been generally weight stable for the past six months (+/- 6 lbs.)
Key exclusion criteria (35 listed)
- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug as well as any product containing cannabidiol (CBD) and tetrahydrocannabinol in the past 30 days.
- Donated blood within 30 days before Screening/baseline
- Inability to provide a venous blood sample
- Participation in another study within 30 days before Screening/baseline
- Being pregnant or planning on becoming pregnant during study participation; or breast feeding
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 ConcentrateMarine Lipid Oil Concentrate softgels | Dietary supplement | Marine Lipid Oil concentrate |
| Dietary SupplementDietary Supplement capsules | Dietary supplement | Marine Lipid Oil concentrate |
| PlaceboPlacebo softgels | Dietary supplement | Placebo |
| PlaceboPlacebo capsules | Dietary supplement | Placebo |
Primary outcome
Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline
Time frame: 60 days
Mean or median change in high sensitivity C-reactive protein (hs-CRP) from baseline to Day 60
4 secondary outcomes
Assessment of the mean or median change in Interleukin-6 (IL-6) relative to baseline
Time frame: 60 days
Assessment of the mean or median change in Tumor Necrosis Factor-alpha (TNF-alpha) relative to baseline
Time frame: 60 days
Assessment of the mean or median change in Erythrocyte Sedimentation Rate (ESR) relative to baseline
Time frame: 60 days
Assessment of the mean or median change in Fibrinogen Activity relative to baseline
Time frame: 60 days
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
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.
- BackgroundDallal, G (2017). Randomization.com. Retrieved from http://www.randomization.com
- 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 26756328Fiala 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. 2016;49(4):1191. doi: 10.3233/JAD-159008. No abstract available.
- 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, Abhilash, M., Gopakumar, G.,et al. 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
- 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 and Dietary Supplement in people with Inflammation and Inflammatory Response, 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 10 inclusion and 35 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: stopped early, 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
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?
Assessment of the mean or median change in high sensitivity C-reactive protein (hs-CRP) relative to baseline (time frame: 60 days). 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 NCT04269876, which also lists 30 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.