Lipid MetabolismMIRACLENCT07502898
Modulating Immune Responses After Consistent Lipid Exposure
A study testing Dairy-derived breakfast shake consumption and Plant-derived breakfast shake consumption in people with Lipid Metabolism and Postprandial Inflammation, run by Wageningen University at 1 site in Netherlands.
Trial summary
Background of the study: Enhanced immune responses can lead to chronic hyperinflammation, which contributes to the development of non-communicable diseases such as type 2 diabetes and cardiovascular disease. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipid Metabolism, Postprandial Inflammation
- What is being tested?
- Dairy-derived breakfast shake consumption and Plant-derived breakfast shake consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jan 2026to 5 Jun 2026
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy man or woman
- Age 40-70y at the time of screening
- BMI of 22-27 kg/m2
- Having a Hb value above 8.4 (men) or 7.4 (women) mmol/L
- Having veins suitable for blood sampling via a catheter cannula (judged by study nurse/ medical doctor)
- Willing to have dairy-based breakfast every day
- Having a mobile phone suitable for installing the research app
- Signed informed consent and able to adhere to the protocol
Who cannot join
- A history of cardiovascular diseases, such as a stroke or heart disease;
- Having an eating disorder;
- Having diabetes (type I or type II);
- Having used antibiotics in the past 3 months;
- Using diabetes medication;
- Using medications that may affect the study results (as assessed by the study physician);
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- Suffering from stomach or intestinal problems, such as Crohn's disease, ulcerative colitis, irritable bowel syndrome, or having undergone major digestive system surgery;
- Having known food allergies or intolerances to foods used in the study (e.g., cow's milk);
- Having an Hb level of less than 8.5 mmol/L (for men) or less than 7.5 mmol/L (for women) - to be tested during the eligibility assessment;
- Being allergic or intolerant to medical skin patches;
- Suffering from chronic or acute inflammatory diseases, such as rheumatoid arthritis or psoriatic arthritis;
- Having an autoimmune disease;
- Having thyroid problems;
- Having recently donated blood (within 2 months before the eligibility assessment) or planning to donate blood during the study period;
- Having recently participated in another medical-scientific study (within 2 months before the eligibility assessment);
- Suffering from severe kidney or liver problems or a chronic kidney or liver disease;
- Following a specific diet that may affect the results or is unsuitable for the study, such as a vegan diet;
- Using tobacco/drugs or smoking (including snus and/or vaping);
- Drinking more than 14 (for women) or 21 (for men) alcoholic drinks per week;
- Being pregnant, planning to become pregnant, or breastfeeding;
- Gained or lost more than 5 kg body weight in the past 3 months;
- Intention to lose or gain more than 5 kg during the study period;
- Intention to change exercise intensity during the study period;
- Not having a mobile phone suitable for using a research application;
- Having another serious medical condition that may interfere with participation, thus being deemed unsuitable for participation in the study as assessed by the study physician or principal investigator (e.g., displaying inappropriate behavior);
- Inability to comply with the study diet
- Inability to understand study information/communicate with staff;
- Being employed or doing an internship at the Department of Human Nutrition and Health of Wageningen University or FrieslandCampina.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The MIRACLE Study: Modulating Immune Responses After Consistent Lipid Exposure
Background of the study:
Enhanced immune responses can lead to chronic hyperinflammation, which contributes to the development of non-communicable diseases such as type 2 diabetes and cardiovascular disease. Poor dietary habits, particularly the consumption of high-fat meals, are thought to trigger this process by increasing the concentration of triglyceride-rich lipoproteins in the bloodstream, resulting in postprandial triglyceridemia. This state stimulates immune cell activation, elevates circulating lipopolysaccharide levels, and enhances the production of inflammatory mediators including IL-6, TNFα, VCAM1, and ICAM1, as well as changes in inflammatory gene expression in peripheral blood mononuclear cells. Until now, most research investigating the relationship between fat intake and postprandial inflammation has focused on the effects of a single high-fat meal. However, in daily life, individuals typically spend the majority of the day-up to 18 hours-in a postprandial state, continuously exposed to multiple meals containing a mix of macronutrients and fats from diverse sources. It remains unclear how repeated fat intake influences the timing, magnitude, and overall pattern of the postprandial immune response. The MIRACLE study is designed to address this gap by exploring how repetitive postprandial fat exposure affects circulating immune cells in healthy individuals, comparing the effects of plant-derived and dairy-derived lipids. The study employs a double-blind, randomized, cross-over, two-armed intervention design in which each participant acts as their own control.
Read more
Objective of the study:
The primary objective of the MIRACLE study is to determine how daily repetitive exposure to lipids from the same source modulates the postprandial immune response, as reflected by IL-6 levels, compared with acute exposure. Postprandial IL-6 concentrations will be measured using multiplex ELISA assays at multiple time points following the high-fat shake at baseline (T0) and after repeated exposure (T1). These data will allow calculation of protein dynamics and incremental area under the curve (iAUC) values for IL-6.
Secondary objectives:
Secondary objectives include comparing postprandial IL-6 iAUC values across T0, T1, and T2; comparing IL-6 responses between the plant- and dairy-derived fats; and identifying mechanisms underlying lipid-induced immunomodulation in PBMCs, including changes in immune cell functioning, phenotypes, and circulating inflammatory parameters. The study will also assess the effects of repeated fat intake on postprandial metabolic markers such as glucose and triglyceride levels. Glucose will be continuously monitored using glucose sensors, while other metabolic parameters will be measured in plasma. Additionally, the relationship between body composition, as assessed by Dual Energy X-ray Absorptiometry (DXA), and postprandial immune and metabolic responses will be evaluated at T0, T1, and T2.
Study design:
On each test day, a catheter cannula will be inserted into an antecubital vein, followed by a 30-minute rest period before measurements begin. Baseline blood samples (t = 0) will be drawn from the catheter, after which participants consume a 0.6 L high-fat shake containing 95 grams of fat from one of the two lipid sources. Subsequent blood samples will be collected at 0.5, 1, 2, 3, 4, and 6 hours post-consumption to monitor postprandial responses. Following the first test day, participants will consume smaller breakfast shakes (~300 mL, ~20 grams of fat) daily for four consecutive weeks, using lipid powders corresponding to the same fat source. After these four weeks, the postprandial test day will be repeated following the same procedures as on the first day.
After the second test day, a washout period of two weeks will take place before participants return for a third test day, again following the same protocol. This will be followed by another washout period of two weeks to three months before beginning the second arm of the study, during which participants will consume lipids from the alternate fat source. Thus, each participant completes both the plant-derived and dairy-derived fat interventions in a randomized order, ensuring within-subject comparison.
Study population:
39 healthy male or female volunteers, age 40-70, BMI 22-27.
Intervention:
2 different breakfast shakes based on either plant-derived or dairy-derived fat.
- Conditions
- Lipid Metabolism, Postprandial Inflammation
- Being tested
- Dairy-derived breakfast shake consumption, Plant-derived breakfast shake consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy-derived breakfast shake consumptionOther
4-week consumption of a breakfast shake containing dairy-derived lipids.
Plant-derived breakfast shake consumptionOther
4-week consumption of a breakfast shake containing plant-derived lipids.
| Study group | Role | What they receive |
|---|---|---|
| Dairy-derived fat shake then plant-derived fat | Active comparator | During the first dietary intervention, the breakfast will consist of a dairy-derived lipid shake. During the second dietary intervention, the breakfast will consist of a plant-derived lipid shake. Receives: Other: Dairy-derived breakfast shake consumption; Other: Plant-derived breakfast shake consumption |
| Plant-derived fat shake then dairy-derived fat shake | Experimental | During the first dietary intervention, the breakfast will consist of a plant-derived lipid shake. During the second dietary intervention, the breakfast will consist of a dairy-derived lipid shake. Receives: Other: Dairy-derived breakfast shake consumption; Other: Plant-derived breakfast shake consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial IL-6 plasma levels in response to a high fat shake before and after the 4-week intervention period.
The main objective is to establish the impact of daily repetitive exposure (after a 4-week intervention period) to lipids from the same lipid source on the postprandial immune response reflected by circulating IL-6 levels, compared to the effects of acute exposure (before a 4-week intervention period) using two different lipid sources in healthy middle-aged men and women. Therefore, we will measure: Postprandial IL-6 levels in the circulation in response to a high fat shake measured as part of a multiplex ELISA assay before and after the 4-week intervention period. By measuring baseline levels and levels at all postprandial sampling time points, we will be able to determine protein dynamics and iAUCs of these cytokines. As we will determine cytokine levels in response to the same high fat shake before and after the 4-week intervention period, we will be able to define whether repetitive intake of fat from the same source alters the postprandial immune response.
Measured: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on the two test days per lipid source.
Secondary outcomes (4)
Postprandial inflammatory plasma proteins in response to a high-fat shake before the 4-week intervention phase, directly after the intervention phase, and after a two-week wash out period.
To define whether changes in the postprandial immune response due to repetitive intake are persistent even when intake is ceased: We will, similar to before and after intervention measurements, asses IL-6 concentrations in the circulation via a multiplex assay, measuring cytokines including, but not limited to IL-6. Other markers include pro-inflammatory cytokines like TNF and IL-8. By measuring baseline levels and levels at all postprandial sampling time points we will be able to determine protein dynamics and iAUC of these cytokines after high fat consumption before the 4-week intervention period, directly after the 4-week intervention period and after a two-week wash out period. This enables the opportunity to compare postprandial responses to a high-fat shake before the 4-week intervention period, directly after the 4-week intervention period and after a 2-week wash out period. These responses will be compared for both the dairy-derived and plant-derived lipid source.
Measured: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following high-fat shake at baseline and up to 6 hours postprandially on all three test days per lipid source.
Postprandial IL-6 plasma levels in response to two different high fat shakes before, directly after the 4-week intervention period and after a 2-week wash out period.
To explore postprandial immunological differences between the plant-derived and dairy-derived fat shakes, postprandial plasma iAUC IL-6 values will be calculated from IL-6 levels at baseline and up to 6 hours postprandially after intake of the high-fat shakes before the intervention phases, after the intervention phases of 4 weeks, and after a wash out period of two weeks. iAUC IL-6 values calculated from the above described time points will be compared for intake of plant-derived and dairy-derived lipids.
Measured: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on all three test days per lipid source.
Postprandial glucose levels in response to two different high fat shakes before, directly after the 4-week intervention period and after a 2-week wash out period.
To explore postprandial glucose responses to the plant-derived and dairy-derived fat shakes, continuous postprandial glucose levels will be measured throughout the study by means of CGMs.
Measured: Levels will be assessed through CGM sensors during the entire duration of the study, so during the full six weeks of both arms including all test days involving high-fat shake consumption.
Postprandial lipid profiles in response to two different high fat shakes before, directly after the 4-week intervention period and after a 2-week wash out period.
Postprandial lipid profiles will be assessed in response to a high-fat shake containing plant-derived or dairy-derived lipids, before a 4-week intervention period, directly after a 4-week intervention period and after 2-week wash out period. In which the intervention covers a breakfast shake consumption containing corresponding lipid compositions. Lipid profiles will defined by measuring triglyceride concentrations, cholesterol levels, free fatty acid levels and free fatty acid compositions in plasma.
Measured: Lipids will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on all three test days per lipid source.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start5 Jan 2026
- Primary completion22 May 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid MetabolismStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina, Amersfoort, The Netherlands
- Responsible party
- Principal investigator, Rinke Stienstra, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502898
- Sponsor's protocol ID
- NL009718
- Acronym
- MIRACLE
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MIRACLE Study: Modulating Immune Responses After Consistent Lipid Exposure
- ClinicalTrials.gov ID
- NCT07502898
- Acronym / sponsor ID
- MIRACLE / NL009718
- Conditions
- Lipid Metabolism, Postprandial Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- FrieslandCampina, Amersfoort, The Netherlands
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 31 Mar 2026 (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.
Background of the study:
Enhanced immune responses can lead to chronic hyperinflammation, which contributes to the development of non-communicable diseases such as type 2 diabetes and cardiovascular disease. Poor dietary habits, particularly the consumption of high-fat meals, are thought to trigger this process by increasing the concentration of triglyceride-rich lipoproteins in the bloodstream, resulting in postprandial triglyceridemia. This state stimulates immune cell activation, elevates circulating lipopolysaccharide levels, and enhances the production of inflammatory mediators including IL-6, TNFα, VCAM1, and ICAM1, as well as changes in inflammatory gene expression in peripheral blood mononuclear cells. Until now, most research investigating the relationship between fat intake and postprandial inflammation has focused on the effects of a single high-fat meal. However, in daily life, individuals typically spend the majority of the day-up to 18 hours-in a postprandial state, continuously exposed to multiple meals containing a mix of macronutrients and fats from diverse sources. It remains unclear how repeated fat intake influences the timing, magnitude, and overall pattern of the postprandial immune response. The MIRACLE study is designed to address this gap by exploring how repetitive postprandial fat exposure affects circulating immune cells in healthy individuals, comparing the effects of plant-derived and dairy-derived lipids. The study employs a double-blind, randomized, cross-over, two-armed intervention design in which each participant acts as their own control.
Objective of the study:
The primary objective of the MIRACLE study is to determine how daily repetitive exposure to lipids from the same source modulates the postprandial immune response, as reflected by IL-6 levels, compared with acute exposure. Postprandial IL-6 concentrations will be measured using multiplex ELISA assays at multiple time points following the high-fat shake at baseline (T0) and after repeated exposure (T1). These data will allow calculation of protein dynamics and incremental area under the curve (iAUC) values for IL-6.
Secondary objectives:
Secondary objectives include comparing postprandial IL-6 iAUC values across T0, T1, and T2; comparing IL-6 responses between the plant- and dairy-derived fats; and identifying mechanisms underlying lipid-induced immunomodulation in PBMCs, including changes in immune cell functioning, phenotypes, and circulating inflammatory parameters. The study will also assess the effects of repeated fat intake on postprandial metabolic markers such as glucose and triglyceride levels. Glucose will be continuously monitored using glucose sensors, while other metabolic parameters will be measured in plasma. Additionally, the relationship between body composition, as assessed by Dual Energy X-ray Absorptiometry (DXA), and postprandial immune and metabolic responses will be evaluated at T0, T1, and T2.
Study design:
On each test day, a catheter cannula will be inserted into an antecubital vein, followed by a 30-minute rest period before measurements begin. Baseline blood samples (t = 0) will be drawn from the catheter, after which participants consume a 0.6 L high-fat shake containing 95 grams of fat from one of the two lipid sources. Subsequent blood samples will be collected at 0.5, 1, 2, 3, 4, and 6 hours post-consumption to monitor postprandial responses. Following the first test day, participants will consume smaller breakfast shakes (~300 mL, ~20 grams of fat) daily for four consecutive weeks, using lipid powders corresponding to the same fat source. After these four weeks, the postprandial test day will be repeated following the same procedures as on the first day.
After the second test day, a washout period of two weeks will take place before participants return for a third test day, again following the same protocol. This will be followed by another washout period of two weeks to three months before beginning the second arm of the study, during which participants will consume lipids from the alternate fat source. Thus, each participant completes both the plant-derived and dairy-derived fat interventions in a randomized order, ensuring within-subject comparison.
Study population:
39 healthy male or female volunteers, age 40-70, BMI 22-27.
Intervention:
2 different breakfast shakes based on either plant-derived or dairy-derived fat.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy-derived fat shake then plant-derived fat | Active comparator | Other: Dairy-derived breakfast shake consumption, Other: Plant-derived breakfast shake consumptionDuring the first dietary intervention, the breakfast will consist of a dairy-derived lipid shake. During the second dietary intervention, the breakfast will consist of a plant-derived lipid shake. |
| Plant-derived fat shake then dairy-derived fat shake | Experimental | Other: Dairy-derived breakfast shake consumption, Other: Plant-derived breakfast shake consumptionDuring the first dietary intervention, the breakfast will consist of a plant-derived lipid shake. During the second dietary intervention, the breakfast will consist of a dairy-derived lipid shake. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Apparently healthy man or woman
- Age 40-70y at the time of screening
- BMI of 22-27 kg/m2
- Having a Hb value above 8.4 (men) or 7.4 (women) mmol/L
- Having veins suitable for blood sampling via a catheter cannula (judged by study nurse/ medical doctor)
Key exclusion criteria (28 listed)
- A history of cardiovascular diseases, such as a stroke or heart disease;
- Having an eating disorder;
- Having diabetes (type I or type II);
- Having used antibiotics in the past 3 months;
- Using diabetes medication;
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 |
|---|---|---|
| Dairy-derived breakfast shake consumption4-week consumption of a breakfast shake containing dairy-derived lipids. | Other | Dairy-derived fat shake then plant-derived fat, Plant-derived fat shake then dairy-derived fat shake |
| Plant-derived breakfast shake consumption4-week consumption of a breakfast shake containing plant-derived lipids. | Other | Dairy-derived fat shake then plant-derived fat, Plant-derived fat shake then dairy-derived fat shake |
Primary outcome
Postprandial IL-6 plasma levels in response to a high fat shake before and after the 4-week intervention period.
Time frame: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on the two test days per lipid source.
The main objective is to establish the impact of daily repetitive exposure (after a 4-week intervention period) to lipids from the same lipid source on the postprandial immune response reflected by circulating IL-6 levels, compared to the effects of acute exposure (before a 4-week intervention period) using two different lipid sources in healthy middle-aged men and women. Therefore, we will measure: Postprandial IL-6 levels in the circulation in response to a high fat shake measured as part of a multiplex ELISA assay before and after the 4-week intervention period. By measuring baseline levels and levels at all postprandial sampling time points, we will be able to determine protein dynamics and iAUCs of these cytokines. As we will determine cytokine levels in response to the same high fat shake before and after the 4-week intervention period, we will be able to define whether repetitive intake of fat from the same source alters the postprandial immune response.
4 secondary outcomes
Postprandial inflammatory plasma proteins in response to a high-fat shake before the 4-week intervention phase, directly after the intervention phase, and after a two-week wash out period.
Time frame: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following high-fat shake at baseline and up to 6 hours postprandially on all three test days per lipid source.
Postprandial IL-6 plasma levels in response to two different high fat shakes before, directly after the 4-week intervention period and after a 2-week wash out period.
Time frame: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on all three test days per lipid source.
Postprandial glucose levels in response to two different high fat shakes before, directly after the 4-week intervention period and after a 2-week wash out period.
Time frame: Levels will be assessed through CGM sensors during the entire duration of the study, so during the full six weeks of both arms including all test days involving high-fat shake consumption.
Postprandial lipid profiles in response to two different high fat shakes before, directly after the 4-week intervention period and after a 2-week wash out period.
Time frame: Lipids will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on all three test days per lipid source.
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 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy-derived breakfast shake consumption and Plant-derived breakfast shake consumption in people with Lipid Metabolism and Postprandial Inflammation, run by Wageningen University at 1 site in Netherlands.
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 8 inclusion and 28 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 26 Aug 2026. 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 Netherlands. 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?
Postprandial IL-6 plasma levels in response to a high fat shake before and after the 4-week intervention period. (time frame: Levels will be assessed in cryopreserved plasma, derived from whole blood collected before and following a high-fat shake at baseline and up to 6 hours postprandially on the two test days per lipid source.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.