Chronic InflammationNCT03625427
Effect of Palmitoleic Acid on C-reactive Protein
A study testing Palmitoleic acid, 500 mg (Dose 1) and Palmitoleic acid, 1,000 mg (Dose 2) in people with Chronic Inflammation and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This clinical trial will test the effects of an n-7 monounsaturated fatty acid known as palmitoleic acid (POA) on a chronic inflammation marker in overweight subjects. The study will enroll male and female subjects from healthy populations with high levels of the inflammatory marker c-reactive protein (CRP). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Inflammation, Overweight
- What is being tested?
- Palmitoleic acid, 500 mg (Dose 1) and Palmitoleic acid, 1,000 mg (Dose 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 29 Nov 2022
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject will be free-living, middle-aged to older men and women between ages 18-80 years with BMIs between 20.0-40.0, and CRP greater than or equal to 2.0 mg/L
- Generally healthy adults
- Understand protocol and comply to take supplements during the trial
- Ability to understand English
- Be able to report to clinical research center, fasting, at least 3 times
- Women who are of childbearing potential should be on birth control (one method is acceptable)
Who cannot join
- BMI higher than 40.0
- Taking anti-hyperlipidemia medications (including statins)
- Taking anti-diabetic medications
- Auto-immune disease
- Documented cognitive impairment
- Unable to draw blood from veins
Show all 16Show fewer
- Alcohol or other drug dependency
- Are currently breastfeeding, or pregnant, or plan to become pregnant
- Have experienced a significant weight change of 10%, or more, of body weight in previous 3 months
- If on hormone therapy, no change during study
- Chronic use of NSAIDs
- Decreased QOL due to pathology, such as cancer, genetic diseases, Rx side effects, or injury
- Taking fish oil, within 8 weeks of enrollment
- Taking Seabuckthorn supplements
- Taking sterols or fat blockers
- Fish allergies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: Effects of Palmitoleic Acid on Circulating C-reactive Protein Levels in Humans
This clinical trial will test the effects of an n-7 monounsaturated fatty acid known as palmitoleic acid (POA) on a chronic inflammation marker in overweight subjects. The study will enroll male and female subjects from healthy populations with high levels of the inflammatory marker c-reactive protein (CRP). Investigators will then determine over time if palmitoleic acid supplementation can lower circulating levels of c-reactive protein. Investigators will administer palmitoleic acid at two doses in addition to a placebo and conduct a double-blind parallel arm study. Circulating CRP will be the primary endpoint and secondary endpoints are Interleukin 6 (IL-6), Tumor necrosis factor (TNF) alpha, ghrelin, peptide tyrosine tyrosine (peptide YY), cardio lipid markers, glucose, insulin, leptin, adiponectin, and red blood cell (RBC) and serum fatty acids.
Read the detailed description
Palmitoleic acid (POA) is a monounsaturated fatty acid that has recently been shown to function as a lipokine and is present in the human diet and in blood serum. While there is emerging evidence that POA can positively impact beta cell proliferation, reduce lipogenesis, support endothelial function, and suppress cytokine production, POA remains to be poorly studied for its beneficial anti-inflammatory potential. The latest studies suggest that POA could attenuate inflammation in metabolically active tissues. Therefore, the objective of this study is to determine if administration of POA in 2 varying doses to overweight participants with biomarkers of chronic inflammation will lower circulating c-reactive protein (CRP) and cytokine levels, as well as improve metabolism by lowering levels of circulating leptin and raising expression of adiponectin. The rationale for focusing on overweight individuals is that they routinely have elevated c-reactive protein levels and are highly prone to have chronic inflammation.
Investigators propose a 12-week randomized, double blinded study to assess changes in select inflammatory markers, ghrelin, peptide YY, cardiovascular lipids, fatty acid levels, and glucose sensitivity markers in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects. Approximately 30% loss of subjects is expected. Administration of the POA supplements and placebo (olive oil capsules) will be double blinded. The study sponsor will hold the code for the subjects and will randomize the capsules. Only the study sponsor will have the code. The identity of the capsules will be revealed after the completion of the study. Subjects will bring back their bottles at each of the concurrent visits and the end of the study to assess compliance and to account for any missed doses of POA. The rationale for selecting olive oil as a placebo is that olive oil is routinely consumed by the public. Additionally, oleic acid (the active ingredient of olive oil) is the most prevalent fatty acid in human circulation, and olive oil is a routine placebo for fatty acid intervention studies. The olive oil will not be extra virgin olive oil that has several bioactive components. POA is virtually tasteless, thus participants should not be able to self-identify their regimen of either placebo or active test agent. The rationale for the experimental dose follows what is commercially available in POA products, which average 700 mg per day and generally range from 450 - 1000 mg per day regimens. The rationale for the 12-week time frame is to ensure uptake of POA into the target cells.
- Conditions
- Chronic Inflammation, Overweight
- Being tested
- Placebo, Palmitoleic acid, 500 mg (Dose 1), Palmitoleic acid, 1,000 mg (Dose 2)
- Keywords
- palmitoleic acid, monounsaturated fatty acid, chronic inflammation
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Olive oil
The placebo is olive oil, stripped of polyphenols, 70% oleic acid, administered as two 1-gram capsules per day. Packaged as single-serve packets containing 2 capsules for each daily dose.
Palmitoleic acid, 500 mg (Dose 1)Dietary supplement
Also called POA
Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA
Palmitoleic acid, 1,000 mg (Dose 2)Dietary supplement
Also called POA
Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo is olive oil, stripped of polyphenols, 70% oleic acid, and will be administered at two 1 gram capsules per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast. Receives: Dietary Supplement: Placebo |
| Palmitoleic acid, 500 mg (Dose 1) | Experimental | POA Dose 1 is a 1 gram capsule containing 500 mg POA and one placebo capsule containing 500 mg olive oil per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast. Receives: Dietary Supplement: Palmitoleic acid, 500 mg (Dose 1) |
| Palmitoleic acid, 1,000 mg (Dose 2) | Experimental | POA Dose 2 is two, 1 gram capsules containing 500 mg POA, totaling 1,000 mg POA per day for twelve weeks.The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast. Receives: Dietary Supplement: Palmitoleic acid, 1,000 mg (Dose 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean c-reactive protein circulating level
Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.
Measured: Week 12
Secondary outcomes (8)
Mean circulating cytokine IL-6 level
Fasting blood draws will be used to evaluate circulating cytokine IL-6 level by ELISA (enzyme-linked immunosorbent assay).
Measured: Week 12
Mean circulating cytokine TNF alpha level
Fasting blood draws will be used to evaluate circulating cytokine TNF alpha level by ELISA (enzyme-linked immunosorbent assay).
Measured: Week 12
Mean circulating ghrelin level
Fasting blood draws will be used to evaluate circulating ghrelin level by ELISA (enzyme-linked immunosorbent assay).
Measured: Week 12
Mean circulating peptide YY level
Fasting blood draws will be used to evaluate circulating peptide YY level by ELISA (enzyme-linked immunosorbent assay).
Measured: Week 12
Mean circulating leptin level
Fasting blood draws will be used to evaluate circulating leptin level by ELISA (enzyme-linked immunosorbent assay).
Measured: Week 12
Mean circulating adiponectin level
Fasting blood draws will be used to evaluate circulating adiponectin level by ELISA (enzyme-linked immunosorbent assay).
Measured: Week 12
Mean glucose/insulin ratio level
Fasting blood draws will be used to evaluate glucose/insulin ratio level.
Measured: Week 12
Mean HbA1c level
Fasting blood draws will be used to evaluate HbA1c level.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start26 Sep 2019
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic InflammationStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-week randomized, double blinded study in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Organic Technologies
- Responsible party
- Sponsor
- Investigators
- Saame R Shaikh, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625427
- Sponsor's protocol ID
- 17-2316
- Status last verified
- Nov 2022
- First submitted
- 7 Aug 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
Publications
Frigolet ME, Gutierrez-Aguilar R. The Role of the Novel Lipokine Palmitoleic Acid in Health and Disease. Adv Nutr. 2017 Jan 17;8(1):173S-181S. doi: 10.3945/an.115.011130. Print 2017 Jan.
PubMed 28096141Yadav A, Kataria MA, Saini V, Yadav A. Role of leptin and adiponectin in insulin resistance. Clin Chim Acta. 2013 Feb 18;417:80-4. doi: 10.1016/j.cca.2012.12.007. Epub 2012 Dec 22.
PubMed 23266767Schirmer M, Smeekens SP, Vlamakis H, Jaeger M, Oosting M, Franzosa EA, Ter Horst R, Jansen T, Jacobs L, Bonder MJ, Kurilshikov A, Fu J, Joosten LAB, Zhernakova A, Huttenhower C, Wijmenga C, Netea MG, Xavier RJ. Linking the Human Gut Microbiome to Inflammatory Cytokine Production Capacity. Cell. 2016 Nov 3;167(4):1125-1136.e8. doi: 10.1016/j.cell.2016.10.020.
PubMed 27814509de Souza CO, Vannice GK, Rosa Neto JC, Calder PC. Is Palmitoleic Acid a Plausible Nonpharmacological Strategy to Prevent or Control Chronic Metabolic and Inflammatory Disorders? Mol Nutr Food Res. 2018 Jan;62(1). doi: 10.1002/mnfr.201700504. Epub 2017 Dec 11.
PubMed 28980402Bernstein AM, Roizen MF, Martinez L. WITHDRWAN: Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: a double-blinded, randomized, placebo controlled study. J Clin Lipidol. 2014 Nov-Dec;8(6):612-617. doi: 10.1016/j.jacl.2014.08.001. Epub 2014 Aug 19.
PubMed 25499944
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Palmitoleic Acid on Circulating C-reactive Protein Levels in Humans
- ClinicalTrials.gov ID
- NCT03625427
- Acronym / sponsor ID
- 17-2316
- Conditions
- Chronic Inflammation, Overweight
- Keywords
- palmitoleic acid, monounsaturated fatty acid, chronic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Organic Technologies
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 10 Aug 2018 (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.
This clinical trial will test the effects of an n-7 monounsaturated fatty acid known as palmitoleic acid (POA) on a chronic inflammation marker in overweight subjects. The study will enroll male and female subjects from healthy populations with high levels of the inflammatory marker c-reactive protein (CRP). Investigators will then determine over time if palmitoleic acid supplementation can lower circulating levels of c-reactive protein. Investigators will administer palmitoleic acid at two doses in addition to a placebo and conduct a double-blind parallel arm study. Circulating CRP will be the primary endpoint and secondary endpoints are Interleukin 6 (IL-6), Tumor necrosis factor (TNF) alpha, ghrelin, peptide tyrosine tyrosine (peptide YY), cardio lipid markers, glucose, insulin, leptin, adiponectin, and red blood cell (RBC) and serum fatty acids.
Detailed description
Palmitoleic acid (POA) is a monounsaturated fatty acid that has recently been shown to function as a lipokine and is present in the human diet and in blood serum. While there is emerging evidence that POA can positively impact beta cell proliferation, reduce lipogenesis, support endothelial function, and suppress cytokine production, POA remains to be poorly studied for its beneficial anti-inflammatory potential. The latest studies suggest that POA could attenuate inflammation in metabolically active tissues. Therefore, the objective of this study is to determine if administration of POA in 2 varying doses to overweight participants with biomarkers of chronic inflammation will lower circulating c-reactive protein (CRP) and cytokine levels, as well as improve metabolism by lowering levels of circulating leptin and raising expression of adiponectin. The rationale for focusing on overweight individuals is that they routinely have elevated c-reactive protein levels and are highly prone to have chronic inflammation.
Investigators propose a 12-week randomized, double blinded study to assess changes in select inflammatory markers, ghrelin, peptide YY, cardiovascular lipids, fatty acid levels, and glucose sensitivity markers in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects. Approximately 30% loss of subjects is expected. Administration of the POA supplements and placebo (olive oil capsules) will be double blinded. The study sponsor will hold the code for the subjects and will randomize the capsules. Only the study sponsor will have the code. The identity of the capsules will be revealed after the completion of the study. Subjects will bring back their bottles at each of the concurrent visits and the end of the study to assess compliance and to account for any missed doses of POA. The rationale for selecting olive oil as a placebo is that olive oil is routinely consumed by the public. Additionally, oleic acid (the active ingredient of olive oil) is the most prevalent fatty acid in human circulation, and olive oil is a routine placebo for fatty acid intervention studies. The olive oil will not be extra virgin olive oil that has several bioactive components. POA is virtually tasteless, thus participants should not be able to self-identify their regimen of either placebo or active test agent. The rationale for the experimental dose follows what is commercially available in POA products, which average 700 mg per day and generally range from 450 - 1000 mg per day regimens. The rationale for the 12-week time frame is to ensure uptake of POA into the target cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 12-week randomized, double blinded study in volunteers consuming either the test agent, 500 mg or 1,000 mg POA per day, or an olive oil containing fatty acid (placebo). There are three arms to study and 41 individuals per arm, thus, a total of 123 subjects.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo is olive oil, stripped of polyphenols, 70% oleic acid, and will be administered at two 1 gram capsules per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast. |
| Palmitoleic acid, 500 mg (Dose 1) | Experimental | Dietary Supplement: Palmitoleic acid, 500 mg (Dose 1)POA Dose 1 is a 1 gram capsule containing 500 mg POA and one placebo capsule containing 500 mg olive oil per day for twelve weeks. The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast. |
| Palmitoleic acid, 1,000 mg (Dose 2) | Experimental | Dietary Supplement: Palmitoleic acid, 1,000 mg (Dose 2)POA Dose 2 is two, 1 gram capsules containing 500 mg POA, totaling 1,000 mg POA per day for twelve weeks.The doses will be administered in single serve packets containing two capsules for each daily dose to be taken at breakfast. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject will be free-living, middle-aged to older men and women between ages 18-80 years with BMIs between 20.0-40.0, and CRP greater than or equal to 2.0 mg/L
- Generally healthy adults
- Understand protocol and comply to take supplements during the trial
- Ability to understand English
- Be able to report to clinical research center, fasting, at least 3 times
Key exclusion criteria (16 listed)
- BMI higher than 40.0
- Taking anti-hyperlipidemia medications (including statins)
- Taking anti-diabetic medications
- Auto-immune disease
- Documented cognitive impairment
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 |
|---|---|---|
| PlaceboAlso: Olive oilThe placebo is olive oil, stripped of polyphenols, 70% oleic acid, administered as two 1-gram capsules per day. Packaged as single-serve packets containing 2 capsules for each daily dose. | Dietary supplement | Placebo |
| Palmitoleic acid, 500 mg (Dose 1)Also: POAPalmitoleic acid (POA) 1 gram capsules containing 500 mg POA | Dietary supplement | Palmitoleic acid, 500 mg (Dose 1) |
| Palmitoleic acid, 1,000 mg (Dose 2)Also: POAPalmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA | Dietary supplement | Palmitoleic acid, 1,000 mg (Dose 2) |
Primary outcome
Mean c-reactive protein circulating level
Time frame: Week 12
Fasting blood draws will be used to evaluate circulating CRP level by high-sensitivity c-reactive protein laboratory blood analysis.
8 secondary outcomes
Mean circulating cytokine IL-6 level
Time frame: Week 12
Mean circulating cytokine TNF alpha level
Time frame: Week 12
Mean circulating ghrelin level
Time frame: Week 12
Mean circulating peptide YY level
Time frame: Week 12
Mean circulating leptin level
Time frame: Week 12
Mean circulating adiponectin level
Time frame: Week 12
Mean glucose/insulin ratio level
Time frame: Week 12
Mean HbA1c level
Time frame: Week 12
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 1 Dec 2022.
- Background: PubMed 28096141Frigolet ME, Gutierrez-Aguilar R. The Role of the Novel Lipokine Palmitoleic Acid in Health and Disease. Adv Nutr. 2017 Jan 17;8(1):173S-181S. doi: 10.3945/an.115.011130. Print 2017 Jan.
- Background: PubMed 23266767Yadav A, Kataria MA, Saini V, Yadav A. Role of leptin and adiponectin in insulin resistance. Clin Chim Acta. 2013 Feb 18;417:80-4. doi: 10.1016/j.cca.2012.12.007. Epub 2012 Dec 22.
- Background: PubMed 27814509Schirmer M, Smeekens SP, Vlamakis H, Jaeger M, Oosting M, Franzosa EA, Ter Horst R, Jansen T, Jacobs L, Bonder MJ, Kurilshikov A, Fu J, Joosten LAB, Zhernakova A, Huttenhower C, Wijmenga C, Netea MG, Xavier RJ. Linking the Human Gut Microbiome to Inflammatory Cytokine Production Capacity. Cell. 2016 Nov 3;167(4):1125-1136.e8. doi: 10.1016/j.cell.2016.10.020.
- Background: PubMed 28980402de Souza CO, Vannice GK, Rosa Neto JC, Calder PC. Is Palmitoleic Acid a Plausible Nonpharmacological Strategy to Prevent or Control Chronic Metabolic and Inflammatory Disorders? Mol Nutr Food Res. 2018 Jan;62(1). doi: 10.1002/mnfr.201700504. Epub 2017 Dec 11.
- Results publication: PubMed 25499944Bernstein AM, Roizen MF, Martinez L. WITHDRWAN: Purified palmitoleic acid for the reduction of high-sensitivity C-reactive protein and serum lipids: a double-blinded, randomized, placebo controlled study. J Clin Lipidol. 2014 Nov-Dec;8(6):612-617. doi: 10.1016/j.jacl.2014.08.001. Epub 2014 Aug 19.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina at Chapel Hill.
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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.
Saame R Shaikh, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitoleic acid, 500 mg (Dose 1) and Palmitoleic acid, 1,000 mg (Dose 2) in people with Chronic Inflammation and Overweight, run by University of North Carolina, Chapel Hill 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 6 inclusion and 16 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 1 Dec 2022. 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 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?
Mean c-reactive protein circulating level (time frame: Week 12). 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 NCT03625427, which also lists 5 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 1 Dec 2022; AzTrials last refreshed its copy on 6 Nov 2026.