Sarcopenia in ElderlyNCT07689994
Evaluation of the Effect of a Seaweed Flour- and Leucine-Enriched Food on Metabolic and Inflammatory Status in Older Adults With Probable Sarcopenia or Sarcopenia
A study testing Standard chocolate-flavored cake, Leucine-Enriched Chocolate Cake and Leucine Plus Seaweed Flour-Enriched Chocolate Cake in people with Sarcopenia in Elderly, run by Finis Terrae University at 1 site in Chile.
Trial summary
Sarcopenia and probable sarcopenia are associated with loss of muscle strength, functional impairment, frailty, and an increased risk of adverse outcomes in older adults. In short-term interventions, structural or functional changes may be modest, whereas certain serum biomarkers of metabolic-nutritional response may… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- Standard chocolate-flavored cake, Leucine-Enriched Chocolate Cake and Leucine Plus Seaweed Flour-Enriched Chocolate Cake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2026to 1 Mar 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 and 80 years at the time of enrollment.
- Ability to understand the study procedures and provide written informed consent.
- SARC-F score ≥4 during screening.
- Reduced muscle strength defined as handgrip strength <27 kg in men or <16 kg in women; alternatively, a time >15 seconds on the five-repetition chair stand test when handgrip dynamometry cannot be validly performed or is contraindicated.
- Availability to attend study visits and comply with daily consumption of the study product for 28 days.
- Willingness to provide fasting blood samples at the Day 0 and Day 28 visits. Exclusion Criteria
Show all 16Show fewer
- Cognitive impairment according to the abbreviated Mini-Mental State Examination (MMSE), using the operational cutoff approved for the study (≤13 points).
- Clinically significant chronic liver disease, clinically significant chronic kidney disease, nephrotic syndrome, active cancer or recent oncological treatment, or any condition that may substantially affect serum TTR levels or increase participant risk.
- Acute infection, acute inflammatory condition, or clinical decompensation at baseline that may interfere with the interpretation of serum TTR measurements.
- Uncontrolled diabetes mellitus or any metabolic condition that, in the investigator's judgment, may increase the risks associated with the intervention.
- Food allergy or intolerance to any component of the study product, including gluten, egg, milk, or other specific cake ingredients.
- Use of leucine, HMB, or protein supplements within the previous 3 months.
- Chronic use of systemic corticosteroids, immunosuppressive agents, or other therapies that may significantly alter the metabolic response under study.
- Untreated thyroid disease or any other unstable endocrine disorder.
- Clinically significant edema, severe dehydration, or any condition that may compromise the validity of bioelectrical impedance measurements.
- Any medical, functional, social, or cognitive condition that may limit safe participation or adherence to the study protocol.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Universidad Finis Terrae
Santiago, 8010000
Cristian R Encina Acosta, Ph D, +56 9 62240100, cencinaa@uft.edu
Conrado S Camilo Manriquez, +56 9 77508471, ccamilo@uft.cl
About this study
Official title: Evaluation of the Effect of a Seaweed Flour- and Leucine-Enriched Food on Metabolic and Inflammatory Status in Older Adults With Probable Sarcopenia or Sarcopenia: A Prospective, Controlled, Randomized, Double-Blind, Three-Arm Parallel Clinical Trial
Sarcopenia and probable sarcopenia are associated with loss of muscle strength, functional impairment, frailty, and an increased risk of adverse outcomes in older adults. In short-term interventions, structural or functional changes may be modest, whereas certain serum biomarkers of metabolic-nutritional response may be more sensitive. In this protocol version, serum transthyretin (TTR) has been selected as the primary outcome, without assuming that it represents, by itself, a direct measure of muscle mass or overall clinical efficacy.
Read the detailed description
Sarcopenia is a progressive skeletal muscle disorder associated with aging and an increased risk of disability, hospitalization, dependency, and mortality. Contemporary consensus definitions identify low muscle strength as the primary characteristic of the condition, while muscle quantity or quality and physical performance are used to support the diagnosis and determine its severity.
In older adults, anabolic resistance reduces the muscle's responsiveness to habitual dietary protein intake. Leucine has been proposed as an amino acid capable of stimulating key anabolic pathways and therefore represents a plausible candidate for short-term nutritional interventions. In turn, Durvillaea incurvata flour provides bioactive compounds and dietary fiber with potential antioxidant and anti-inflammatory properties, although clinical evidence supporting its use in sarcopenia remains limited.
From a methodological perspective, a 28-day follow-up period may be sufficient to detect early metabolic and nutritional responses, but it may be insufficient to demonstrate robust clinical changes in muscle strength, muscle mass, or physical performance. For this reason, serum TTR has been selected as the primary short-term response outcome in the present protocol.
The selection of serum TTR as the primary outcome requires careful interpretation. Serum TTR levels may be influenced by protein-energy intake, liver function, inflammatory status, and intercurrent clinical conditions. Accordingly, in this protocol, serum TTR will not be interpreted as a direct surrogate of muscle mass or as a stand-alone measure of clinical efficacy. Rather, it will be considered a serum marker of early metabolic and nutritional response, whose interpretation will be complemented by functional, body composition, inflammatory, and safety-related outcomes.
This study is therefore designed as an exploratory, randomized proof-of-concept trial to determine whether the combination of leucine and seaweed flour improves serum TTR and whether this response is accompanied by consistent secondary changes in muscle strength, mobility, body composition, and the metabolic-inflammatory profile.
- Conditions
- Sarcopenia in Elderly
- Being tested
- Standard chocolate-flavored cake, Leucine-Enriched Chocolate Cake, Leucine Plus Seaweed Flour-Enriched Chocolate Cake
- Keywords
- Sarcopenia, Seaweed, Inflammatory status, older adults
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard chocolate-flavored cakeDietary supplement
Also called Cake
Participants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour.
Leucine-Enriched Chocolate CakeDietary supplement
Also called Leucin
Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days.
Leucine Plus Seaweed Flour-Enriched Chocolate CakeDietary supplement
Also called Seaweed
Participants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Control chocolate cake | Placebo comparator | One daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days Receives: Dietary Supplement: Standard chocolate-flavored cake |
| Leucine-enriched chocolate cake | Active comparator | One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days Receives: Dietary Supplement: Leucine-Enriched Chocolate Cake |
| Leucine and Durvillaea incurvata Flour-Enriched Chocolate Cake | Experimental | One daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour for 28 consecutive days. Receives: Dietary Supplement: Leucine Plus Seaweed Flour-Enriched Chocolate Cake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in fasting serum transthyretin concentration at day 28.
Fasting serum transthyretin (TTR; prealbumin) concentration (mg/dL) measured using Human Transthyretin/Prealbumin ELISA Kit (NBP2-60516, Bio-Techne, Novus Biologicals). The outcome is the change from Day 0 to Day 28 according to the Statistical Analysis Plan.
Measured: 28 days
Secondary outcomes (5)
Change from baseline in handgrip strength at day 28.
Handgrip strength (kg) measured by dynamometry under standardized conditions. The operational measure, such as the best of three valid attempts.
Measured: 28 days
Change from baseline in 4-meter gait speed at day 28.
Usual gain speed (m/s) calculated from the 4-meter walk test under standardized condition.
Measured: 28 days
Change from baseline in appendicular muscle mass index at day 28.
Appendicular skeletal muscle mass index (kg/m2) measured calculated as appendicular skeletal muscle mass divided by height squared
Measured: 28 days
Percentage (%) of prescribed study product serving consumed during the intervention.
Adherence calculated from returned product counts and participant self-report as number of consumed servings divided by the number of prescribed servings.
Measured: 28 days
Number of participants with adequate adherence during the intervention.
Participants who consume at least 80% of prescribed study product serving during the 28-day intervention.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
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 Sarcopenia in ElderlyStudies 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
- Parallel groups
- Model description
- Randomized, single-center, double-blind, controlled, three-arm parallel clinical trial with a 1:1:1 allocation ratio and a 28-day follow-up period. The study is designed as an exploratory proof-of-concept trial focused on early efficacy and safety.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finis Terrae University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Salomé Mariotti Celis, Finis Terrae University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689994
- Sponsor's protocol ID
- 25-124
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calvani R, Marini F, Cesari M, Tosato M, Anker SD, von Haehling S, Miller RR, Bernabei R, Landi F, Marzetti E; SPRINTT consortium. Biomarkers for physical frailty and sarcopenia: state of the science and future developments. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):278-86. doi: 10.1002/jcsm.12051. Epub 2015 Jul 7.
PubMed 26675566Shenkin A. Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9. doi: 10.1373/clinchem.2006.077412. No abstract available.
PubMed 17138848Beaudart C, Alcazar J, Aprahamian I, Batsis JA, Yamada Y, Prado CM, Reginster JY, Sanchez-Rodriguez D, Lim WS, Sim M, von Haehling S, Woo J, Duque G; Global Leadership Initiative in Sarcopenia (GLIS) group. Health outcomes of sarcopenia: a consensus report by the outcome working group of the Global Leadership Initiative in Sarcopenia (GLIS). Aging Clin Exp Res. 2025 Mar 22;37(1):100. doi: 10.1007/s40520-025-02995-9.
PubMed 40120052Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
PubMed 32033882Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Seaweed Flour- and Leucine-Enriched Food on Metabolic and Inflammatory Status in Older Adults With Probable Sarcopenia or Sarcopenia: A Prospective, Controlled, Randomized, Double-Blind, Three-Arm Parallel Clinical Trial
- ClinicalTrials.gov ID
- NCT07689994
- Acronym / sponsor ID
- 25-124
- Conditions
- Sarcopenia in Elderly
- Keywords
- Sarcopenia, Seaweed, Inflammatory status, older adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Finis Terrae UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Jul 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.
Sarcopenia and probable sarcopenia are associated with loss of muscle strength, functional impairment, frailty, and an increased risk of adverse outcomes in older adults. In short-term interventions, structural or functional changes may be modest, whereas certain serum biomarkers of metabolic-nutritional response may be more sensitive. In this protocol version, serum transthyretin (TTR) has been selected as the primary outcome, without assuming that it represents, by itself, a direct measure of muscle mass or overall clinical efficacy.
Detailed description
Sarcopenia is a progressive skeletal muscle disorder associated with aging and an increased risk of disability, hospitalization, dependency, and mortality. Contemporary consensus definitions identify low muscle strength as the primary characteristic of the condition, while muscle quantity or quality and physical performance are used to support the diagnosis and determine its severity.
In older adults, anabolic resistance reduces the muscle's responsiveness to habitual dietary protein intake. Leucine has been proposed as an amino acid capable of stimulating key anabolic pathways and therefore represents a plausible candidate for short-term nutritional interventions. In turn, Durvillaea incurvata flour provides bioactive compounds and dietary fiber with potential antioxidant and anti-inflammatory properties, although clinical evidence supporting its use in sarcopenia remains limited.
From a methodological perspective, a 28-day follow-up period may be sufficient to detect early metabolic and nutritional responses, but it may be insufficient to demonstrate robust clinical changes in muscle strength, muscle mass, or physical performance. For this reason, serum TTR has been selected as the primary short-term response outcome in the present protocol.
The selection of serum TTR as the primary outcome requires careful interpretation. Serum TTR levels may be influenced by protein-energy intake, liver function, inflammatory status, and intercurrent clinical conditions. Accordingly, in this protocol, serum TTR will not be interpreted as a direct surrogate of muscle mass or as a stand-alone measure of clinical efficacy. Rather, it will be considered a serum marker of early metabolic and nutritional response, whose interpretation will be complemented by functional, body composition, inflammatory, and safety-related outcomes.
This study is therefore designed as an exploratory, randomized proof-of-concept trial to determine whether the combination of leucine and seaweed flour improves serum TTR and whether this response is accompanied by consistent secondary changes in muscle strength, mobility, body composition, and the metabolic-inflammatory profile.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, single-center, double-blind, controlled, three-arm parallel clinical trial with a 1:1:1 allocation ratio and a 28-day follow-up period. The study is designed as an exploratory proof-of-concept trial focused on early efficacy and safety.
| Arm | Type | Receives |
|---|---|---|
| Control chocolate cake | Placebo comparator | Dietary Supplement: Standard chocolate-flavored cakeOne daily serving of standard chocolate-flavored cake without added leucine or seaweed flour for 28 consecutive days |
| Leucine-enriched chocolate cake | Active comparator | Dietary Supplement: Leucine-Enriched Chocolate CakeOne daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine for 28 consecutive days |
| Leucine and Durvillaea incurvata Flour-Enriched Chocolate Cake | Experimental | Dietary Supplement: Leucine Plus Seaweed Flour-Enriched Chocolate CakeOne daily serving of standard chocolate-flavored cake supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour for 28 consecutive days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age between 60 and 80 years at the time of enrollment.
- Ability to understand the study procedures and provide written informed consent.
- SARC-F score ≥4 during screening.
- Reduced muscle strength defined as handgrip strength <27 kg in men or <16 kg in women; alternatively, a time >15 seconds on the five-repetition chair stand test when handgrip dynamometry cannot be validly performed or is contraindicated.
- Availability to attend study visits and comply with daily consumption of the study product for 28 days.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Standard chocolate-flavored cakeAlso: CakeParticipants will consume one standard chocolate-flavored cake serving daily for 28 days, without added leucine or seaweed flour. | Dietary supplement | Control chocolate cake |
| Leucine-Enriched Chocolate CakeAlso: LeucinParticipants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine daily for 28 days. | Dietary supplement | Leucine-enriched chocolate cake |
| Leucine Plus Seaweed Flour-Enriched Chocolate CakeAlso: SeaweedParticipants will consume one chocolate-flavored cake serving supplemented with 3 g of leucine and 3 g of Durvillaea incurvata flour daily for 28 days. | Dietary supplement | Leucine and Durvillaea incurvata Flour-Enriched Chocolate Cake |
Primary outcome
Change from baseline in fasting serum transthyretin concentration at day 28.
Time frame: 28 days
Fasting serum transthyretin (TTR; prealbumin) concentration (mg/dL) measured using Human Transthyretin/Prealbumin ELISA Kit (NBP2-60516, Bio-Techne, Novus Biologicals). The outcome is the change from Day 0 to Day 28 according to the Statistical Analysis Plan.
5 secondary outcomes
Change from baseline in handgrip strength at day 28.
Time frame: 28 days
Change from baseline in 4-meter gait speed at day 28.
Time frame: 28 days
Change from baseline in appendicular muscle mass index at day 28.
Time frame: 28 days
Percentage (%) of prescribed study product serving consumed during the intervention.
Time frame: 28 days
Number of participants with adequate adherence during the intervention.
Time frame: 28 days
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 8 Jul 2026.
- Background: PubMed 26675566Calvani R, Marini F, Cesari M, Tosato M, Anker SD, von Haehling S, Miller RR, Bernabei R, Landi F, Marzetti E; SPRINTT consortium. Biomarkers for physical frailty and sarcopenia: state of the science and future developments. J Cachexia Sarcopenia Muscle. 2015 Dec;6(4):278-86. doi: 10.1002/jcsm.12051. Epub 2015 Jul 7.
- Background: PubMed 17138848Shenkin A. Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9. doi: 10.1373/clinchem.2006.077412. No abstract available.
- Background: PubMed 40120052Beaudart C, Alcazar J, Aprahamian I, Batsis JA, Yamada Y, Prado CM, Reginster JY, Sanchez-Rodriguez D, Lim WS, Sim M, von Haehling S, Woo J, Duque G; Global Leadership Initiative in Sarcopenia (GLIS) group. Health outcomes of sarcopenia: a consensus report by the outcome working group of the Global Leadership Initiative in Sarcopenia (GLIS). Aging Clin Exp Res. 2025 Mar 22;37(1):100. doi: 10.1007/s40520-025-02995-9.
- Background: PubMed 32033882Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard chocolate-flavored cake, Leucine-Enriched Chocolate Cake and Leucine Plus Seaweed Flour-Enriched Chocolate Cake in people with Sarcopenia in Elderly, run by Finis Terrae University at 1 site in Chile.
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 16 inclusion and 0 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: opening soon, as of the sponsor's last update on 8 Jul 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 Chile. 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?
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 María S Mariotti Celis, Ph D (+56 9 82332421, mmariotti@uft.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in fasting serum transthyretin concentration at day 28. (time frame: 28 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 NCT07689994, 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 8 Jul 2026.