Metabolic Diseases, Type 2 Diabetes, Cardiovascular DiseaseSCONENCT07420023
The Satiety Control Optimization by Nutritional Enhancement Study
A study testing Cereal-based food, Fiber-enriched scones in people with Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease, run by University College Cork at 1 site in Ireland.
Trial summary
High-glycaemic foods contribute to elevated risk of obesity, type 2 diabetes, and cardiometabolic disease. Replacing digestible carbohydrates with dietary fibres is known to reduce postprandial glycaemic excursions, enhance satiety, and support beneficial microbial fermentation. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
- What is being tested?
- Cereal-based food, Fiber-enriched scones
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIreland
- Study dates
- 18 Aug 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age.
- Have a BMI of =25<30kg/m2(overweight).
- Have a waist circumference of >94cm for a male, >80cm for a female (increased risk of metabolic syndrome).
- Have had a stable body weight (<5% change over the past three months).
- Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).
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- Be willing to avoid consuming dietary supplements (at the discretion of the investigator), prebiotics, probiotics, or fibre-rich supplements within four weeks before the baseline visit, and until the end of the study.
- Be willing to avoid vigorous physical activities on the interventional days (defined as any physical activity that is planned to achieve a fitness goal).
- Be willing to consume the investigational food products and menu plan daily for the duration of the study.
Who cannot join
- Pregnant, lactating, or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have had antibiotic treatment within three months before baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include anti-inflammatory drugs, H2 blockers, antacids, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, and immunosuppressant medication. Participants should have a wash-out period of at least two weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed into the study if the dose has been stable for at least two months before the study baseline visit.
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have a habitual alcohol consumption of >2 alcoholic beverages/day (>28g ethanol daily).
- Follow a vegetarian or vegan diet.
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- Have a typical fibre intake of >30g per day.
- Have experienced major dietary changes within three months before the study baseline.
- Plan major lifestyle changes (diet, physical activity, or travel) during the study period.
- Have a clinically diagnosed eating disorder.
- Have a food allergy or intolerance that would preclude study product intake (for example, eggs, gluten, nuts, milk, or any other food allergy or intolerance).
- Have an active gastrointestinal disorder or previous gastrointestinal surgery.
- Have a significant active and medically-diagnosed acute or chronic co-existing illness including: metabolic, psychiatric, cardiovascular, endocrinological, immunological condition, gastrointestinal disease or any other condition which contraindicates, in the investigator's judgement, entry to the study (such as, diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers, hepatitis A/B/C, HIV, cancer, diabetes etc) or a significant history of such diseases.
- Are severely immunocompromised (e.g., HIV positive, transplant patient, on anti-rejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last 12 months).
- Have a malignant disease or concomitant end-stage organ disease.
- Have symptomatic respiratory or cardiac illness.
- Experience alarm features such as sudden weight loss, rectal bleeding, a recent change in bowel habits, or significant abdominal pain within three months before baseline.
- Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study protocol.
- Are receiving treatment involving experimental drugs.
- If the participant has been in a recent experimental trial, these must have been completed not less than 30 days before this study.
- Individuals who regularly undertake rigorous exercise.
- Individuals who smoke or vape.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
University College Cork
Cork
Manon Oliero, PhD, +353 (0)86 199 2919, sconestudy@ucc.ie
About this study
Official title: Characterization of the Impact of Dietary Fibre Interactions in Food Products on Postprandial Glycaemic Response, Satiety, and Microbiome Composition and Function
High-glycaemic foods contribute to elevated risk of obesity, type 2 diabetes, and cardiometabolic disease. Replacing digestible carbohydrates with dietary fibres is known to reduce postprandial glycaemic excursions, enhance satiety, and support beneficial microbial fermentation. However, limited evidence exists on how interactions between different isolated fibres within a processed food matrix may modulate these responses, particularly when such interactions could recreate structural features of intrinsic plant fibre networks that naturally restrict starch accessibility and alter fermentation dynamics.
This randomized, single-blinded, placebo-controlled crossover trial will investigate how isolated dietary fibres, alone and in combination, influence metabolic and microbial responses when incorporated into a commonly consumed cereal-based food (scone). Overweight but otherwise healthy adults (BMI 25-<30 kg/m²) will consume seven fibre-enriched scone formulations across two consecutive mornings per intervention phase. Outcomes include postprandial glycaemic response measured via continuous glucose monitoring (primary outcome), perceived satiety and energy intake, gastrointestinal symptoms, fermentation dynamics via breath hydrogen and methane, and gut microbiota composition assessed through 16S rRNA sequencing. This study will generate novel insights into potential synergistic interactions between isolated fibres within a food matrix and their consequences for glycaemic control, satiety, microbial fermentation, and community. Findings will inform next-generation food design strategies aimed at replicating complex intrinsic fibre structures to enhance the health impact of processed foods.
Read the detailed description
The study will be conducted over a 28-day period, during which each participant will complete a structured sequence of controlled dietary interventions while continuous metabolic and gastrointestinal data are collected. Participants will rotate through seven intervention phases, each lasting two consecutive days. In each phase, they will consume one of the fibre-enriched scone formulations provided by the research team, accompanied by standardized, calorie-controlled meals. Snacks will be provided but may be consumed ad libitum, ensuring consistent macronutrient intake across intervention days while preserving ecological validity.
To maintain data quality and support participant adherence, each intervention phase is followed by a washout day during which participants return to their habitual diet. These washout periods minimize carryover effects from previous fibre exposures and allow both glycaemic responses and microbial activity to stabilize before the next intervention. Weekends are intentionally left free of study foods and structured routines, a design choice that improves flexibility, reduces participant fatigue, and helps maintain high compliance without compromising continuous data collection.
Upon enrolment, participants will receive two continuous glucose monitoring (CGM) sensors, each worn for 14 days, ensuring uninterrupted interstitial glucose measurement throughout the study. This approach allows precise characterization of postprandial glycaemic responses to each test food under free-living conditions while minimizing participant burden.
To assess fermentation dynamics, participants will provide breath samples using a portable breath-analysis device capable of quantifying hydrogen and methane. Measurements will be collected immediately before and after each intervention meal, enabling assessment of both the magnitude and timing of microbial fermentation in response to the different fibre combinations.
Gastrointestinal sensations and tolerance will be evaluated using validated questionnaires that capture bloating, discomfort, stool frequency, and form (including the Bristol Stool Scale), and other relevant symptoms. Satiety and hunger perception will be assessed using standardized visual analogue scales administered before and after each intervention meal, providing detailed insight into subjective digestive and appetite-related responses.
Eligible participants are healthy men and women aged 18-45 years with a body mass index between 25 and <30 kg/m². All participants must be weight-stable for at least three months prior to enrolment and free from metabolic, gastrointestinal, or chronic inflammatory diseases. Exclusion criteria include diagnosed diabetes or pre-diabetes, use of glucose-modulating or lipid-lowering medications, recent antibiotic therapy, adherence to restrictive diets (such as ketogenic, vegan, or medically prescribed regimens), significant food allergies relevant to study products, smoking, pregnancy or breastfeeding, and any condition that may interfere with digestion, absorption, or gut microbiota composition.
Overall, the combination of controlled feeding, continuous glucose monitoring, breath-based fermentation measurements, validated gastrointestinal and satiety assessments, and microbiome profiling will generate a comprehensive dataset describing how isolated dietary fibres shape metabolic, digestive, and microbial responses when incorporated into a familiar cereal-based food matrix.
- Being tested
- Cereal-based food, Fiber-enriched scones
- Keywords
- Dietary fibers, metabolic diseases, blood glucose, satiety, fermentation, food matrix
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereal-based food, Fiber-enriched sconesOther
Scone supplemented with 4 to 20 grams of fibres, nicknamed (A, B, C, D, E, F, G)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | The order in which each participant receives the seven different scone recipes. D, C, E, A, F, B, G Receives: Other: Cereal-based food, Fiber-enriched scones |
| B | Experimental | The order in which each participant receives the seven different scone recipes. C, D, G, B, A, F, E Receives: Other: Cereal-based food, Fiber-enriched scones |
| C | Experimental | The order in which each participant receives the seven different scone recipes. E, F, A, G, D, C, B Receives: Other: Cereal-based food, Fiber-enriched scones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on Postprandial Glycaemic Response
Change in interstitial glucose concentration following consumption of each interventional meal, measured using continuous glucose monitoring. The primary endpoint is the incremental area under the curve (iAUC) for glucose over 2 hours post-consumption between treatments.
Measured: Measured continuously over each 2-day intervention phase, with readings recorded every 15 minutes, covering all seven scone interventions plus baseline across the 28-day study period.
Secondary outcomes (4)
Changes in participant-reported Perceived Satiety
Subjective feelings of hunger and fullness were assessed using a validated Satiety Labeled Intensity Magnitude (SLIM) visual analogue scale (VAS) ranging from -50 ("greatest imaginable hunger") to +50 ("greatest fullness"), administered before and after each intervention meal. Snack consumption, provided ad libitum, was also monitored as an objective proxy for satiety.
Measured: Before and after each breakfast, lunch, and dinner, measurements were taken over the three days of baseline (days 1-3) and during each 2-day intervention phase for all seven scone interventions (days 5-6, 8-9, 12-13, 15-16, 19-20, 22-23, 26-27).
Gastrointestinal Tolerance and Symptoms
Participant-reported GI symptoms (bloating, cramping, stool frequency and form, discomfort) collected via validated questionnaires, including the Bristol Stool Scale, to assess tolerance to fibre-enriched scones
Measured: 8 times total at baseline (day 3) and on the second day of each intervention phase (days 6, 9, 13, 16, 20, 23, 27)
Bacterial Fermentation
Measurement of breath hydrogen and methane concentrations to assess colonic fermentation and transit of fibre, using a portable breath-analysis device
Measured: Before and after each breakfast, lunch, and dinner, measurements were taken over the three days of baseline (days 1-3) and during each 2-day intervention phase for all seven scone interventions (days 5-6, 8-9, 12-13, 15-16, 19-20, 22-23, 26-27).
Gut Microbiome Composition
Analysis of participant faecal samples using 16S rRNA gene sequencing to determine microbiota composition, diversity, and potential functional changes in response to individual or combined dietary fibres.
Measured: 8 times total a day after baseline (day 4) and on the day after each intervention phase (days 7, 10, 14, 17, 21, 24, 28).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start18 Aug 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Diseases, Type 2 Diabetes, Cardiovascular DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-blinded, randomised, crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Walter, PhD, Principal investigator, University College Cork; University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420023
- Sponsor's protocol ID
- APC-189
- Acronym
- SCONE
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Impact of Dietary Fibre Interactions in Food Products on Postprandial Glycaemic Response, Satiety, and Microbiome Composition and Function
- ClinicalTrials.gov ID
- NCT07420023
- Acronym / sponsor ID
- SCONE / APC-189
- Keywords
- Dietary fibers, metabolic diseases, blood glucose, satiety, fermentation, food matrix
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 19 Feb 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.
High-glycaemic foods contribute to elevated risk of obesity, type 2 diabetes, and cardiometabolic disease. Replacing digestible carbohydrates with dietary fibres is known to reduce postprandial glycaemic excursions, enhance satiety, and support beneficial microbial fermentation. However, limited evidence exists on how interactions between different isolated fibres within a processed food matrix may modulate these responses, particularly when such interactions could recreate structural features of intrinsic plant fibre networks that naturally restrict starch accessibility and alter fermentation dynamics.
This randomized, single-blinded, placebo-controlled crossover trial will investigate how isolated dietary fibres, alone and in combination, influence metabolic and microbial responses when incorporated into a commonly consumed cereal-based food (scone). Overweight but otherwise healthy adults (BMI 25-<30 kg/m²) will consume seven fibre-enriched scone formulations across two consecutive mornings per intervention phase. Outcomes include postprandial glycaemic response measured via continuous glucose monitoring (primary outcome), perceived satiety and energy intake, gastrointestinal symptoms, fermentation dynamics via breath hydrogen and methane, and gut microbiota composition assessed through 16S rRNA sequencing. This study will generate novel insights into potential synergistic interactions between isolated fibres within a food matrix and their consequences for glycaemic control, satiety, microbial fermentation, and community. Findings will inform next-generation food design strategies aimed at replicating complex intrinsic fibre structures to enhance the health impact of processed foods.
Detailed description
The study will be conducted over a 28-day period, during which each participant will complete a structured sequence of controlled dietary interventions while continuous metabolic and gastrointestinal data are collected. Participants will rotate through seven intervention phases, each lasting two consecutive days. In each phase, they will consume one of the fibre-enriched scone formulations provided by the research team, accompanied by standardized, calorie-controlled meals. Snacks will be provided but may be consumed ad libitum, ensuring consistent macronutrient intake across intervention days while preserving ecological validity.
To maintain data quality and support participant adherence, each intervention phase is followed by a washout day during which participants return to their habitual diet. These washout periods minimize carryover effects from previous fibre exposures and allow both glycaemic responses and microbial activity to stabilize before the next intervention. Weekends are intentionally left free of study foods and structured routines, a design choice that improves flexibility, reduces participant fatigue, and helps maintain high compliance without compromising continuous data collection.
Upon enrolment, participants will receive two continuous glucose monitoring (CGM) sensors, each worn for 14 days, ensuring uninterrupted interstitial glucose measurement throughout the study. This approach allows precise characterization of postprandial glycaemic responses to each test food under free-living conditions while minimizing participant burden.
To assess fermentation dynamics, participants will provide breath samples using a portable breath-analysis device capable of quantifying hydrogen and methane. Measurements will be collected immediately before and after each intervention meal, enabling assessment of both the magnitude and timing of microbial fermentation in response to the different fibre combinations.
Gastrointestinal sensations and tolerance will be evaluated using validated questionnaires that capture bloating, discomfort, stool frequency, and form (including the Bristol Stool Scale), and other relevant symptoms. Satiety and hunger perception will be assessed using standardized visual analogue scales administered before and after each intervention meal, providing detailed insight into subjective digestive and appetite-related responses.
Eligible participants are healthy men and women aged 18-45 years with a body mass index between 25 and <30 kg/m². All participants must be weight-stable for at least three months prior to enrolment and free from metabolic, gastrointestinal, or chronic inflammatory diseases. Exclusion criteria include diagnosed diabetes or pre-diabetes, use of glucose-modulating or lipid-lowering medications, recent antibiotic therapy, adherence to restrictive diets (such as ketogenic, vegan, or medically prescribed regimens), significant food allergies relevant to study products, smoking, pregnancy or breastfeeding, and any condition that may interfere with digestion, absorption, or gut microbiota composition.
Overall, the combination of controlled feeding, continuous glucose monitoring, breath-based fermentation measurements, validated gastrointestinal and satiety assessments, and microbiome profiling will generate a comprehensive dataset describing how isolated dietary fibres shape metabolic, digestive, and microbial responses when incorporated into a familiar cereal-based food matrix.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Single-blinded, randomised, crossover
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Cereal-based food, Fiber-enriched sconesThe order in which each participant receives the seven different scone recipes. D, C, E, A, F, B, G |
| B | Experimental | Other: Cereal-based food, Fiber-enriched sconesThe order in which each participant receives the seven different scone recipes. C, D, G, B, A, F, E |
| C | Experimental | Other: Cereal-based food, Fiber-enriched sconesThe order in which each participant receives the seven different scone recipes. E, F, A, G, D, C, B |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be willing and able to give written informed consent.
- Be between 18 and 45 years of age.
- Have a BMI of =25<30kg/m2(overweight).
- Have a waist circumference of >94cm for a male, >80cm for a female (increased risk of metabolic syndrome).
- Have had a stable body weight (<5% change over the past three months).
Key exclusion criteria (22 listed)
- Pregnant, lactating, or post-menopausal women, or women who are planning to become pregnant over the study period.
- Have had antibiotic treatment within three months before baseline.
- Are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of study results; to include anti-inflammatory drugs, H2 blockers, antacids, proton pump inhibitors, anti-hypertensive medications, corticosteroids, laxatives, enemas, antibiotics, anti-coagulants, and immunosuppressant medication. Participants should have a wash-out period of at least two weeks for each of these medications except for antibiotics, which should not have been taken in the previous three months. Participants taking proton pump inhibitors and medications for chronic conditions (e.g., anti-hypertensive medication) will be allowed into the study if the dose has been stable for at least two months before the study baseline visit.
- Have a history or indication of drug and/or alcohol abuse at the time of enrolment.
- Have a habitual alcohol consumption of >2 alcoholic beverages/day (>28g ethanol daily).
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 |
|---|---|---|
| Cereal-based food, Fiber-enriched sconesScone supplemented with 4 to 20 grams of fibres, nicknamed (A, B, C, D, E, F, G) | Other | A, B, C |
Primary outcome
Impact on Postprandial Glycaemic Response
Time frame: Measured continuously over each 2-day intervention phase, with readings recorded every 15 minutes, covering all seven scone interventions plus baseline across the 28-day study period.
Change in interstitial glucose concentration following consumption of each interventional meal, measured using continuous glucose monitoring. The primary endpoint is the incremental area under the curve (iAUC) for glucose over 2 hours post-consumption between treatments.
4 secondary outcomes
Changes in participant-reported Perceived Satiety
Time frame: Before and after each breakfast, lunch, and dinner, measurements were taken over the three days of baseline (days 1-3) and during each 2-day intervention phase for all seven scone interventions (days 5-6, 8-9, 12-13, 15-16, 19-20, 22-23, 26-27).
Gastrointestinal Tolerance and Symptoms
Time frame: 8 times total at baseline (day 3) and on the second day of each intervention phase (days 6, 9, 13, 16, 20, 23, 27)
Bacterial Fermentation
Time frame: Before and after each breakfast, lunch, and dinner, measurements were taken over the three days of baseline (days 1-3) and during each 2-day intervention phase for all seven scone interventions (days 5-6, 8-9, 12-13, 15-16, 19-20, 22-23, 26-27).
Gut Microbiome Composition
Time frame: 8 times total a day after baseline (day 4) and on the day after each intervention phase (days 7, 10, 14, 17, 21, 24, 28).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
Jens Walter, PhD principal investigator
University College Cork; University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereal-based food, Fiber-enriched scones in people with Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease, run by University College Cork at 1 site in Ireland.
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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 19 Feb 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manon Oliero, PhD (+353 (0)86 199 2919, sconestudy@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on Postprandial Glycaemic Response (time frame: Measured continuously over each 2-day intervention phase, with readings recorded every 15 minutes, covering all seven scone interventions plus baseline across the 28-day study period.). 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 19 Feb 2026.