Cardiovascular Disease (CVD)Sacha-Q10NCT07792005
Sacha Inchi-CoQ10 Supplementation and Cardiovascular Health
A study testing Sacha-Q10 Plus in people with Cardiovascular Disease (CVD) and Elevated Cardiovascular Risk, run by Hospital Pengajar Universiti Putra Malaysia.
Trial summary
The goal of this clinical trial is to learn if Sacha Inchi-CoQ10 supplementation can improve cardiovascular health in adults who have an increased risk of cardiovascular disease. The study will also learn about the safety and tolerability of Sacha Inchi-CoQ10 supplementation. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cardiovascular Disease (CVD), Elevated Cardiovascular Risk, Endothelial Dysfunction
- What is being tested?
- Sacha-Q10 Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40 to 75 years.
- Male or female.
- Have one or more cardiovascular risk factors or stable cardiovascular disease, including:
- Hypertension; Dyslipidaemia; Controlled diabetes mellitus; or High cardiovascular risk, defined as Framingham Risk Score ≥10%.
- Able to provide written informed consent.
- Able and willing to comply with the study procedures and follow-up visits.
Who cannot join
- Unstable cardiovascular disease.
- Severe renal impairment.
- Severe hepatic impairment.
- Active malignancy.
- Pregnant or lactating women.
- Known allergy to any study components.
Show all 9Show fewer
- Current use of omega-3, Sacha Inchi oil or Coenzyme Q10 supplements within the past three months.
- Participation in another clinical trial within the past three months.
- Impaired decision-making capacity, including cognitive impairment or severe mental disorder.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Sacha Inchi-CoQ10 Supplementation on Endothelial-related Cardiovascular Function, Cardiometabolic Risk Factors, and Inflammatory Biomarkers Among Adults at Increased Cardiovascular Risk: A Double-blind Randomized Controlled Trial
The goal of this clinical trial is to learn if Sacha Inchi-CoQ10 supplementation can improve cardiovascular health in adults who have an increased risk of cardiovascular disease. The study will also learn about the safety and tolerability of Sacha Inchi-CoQ10 supplementation.
The main questions it aims to answer are:
Read more
Does Sacha Inchi-CoQ10 supplementation improve cardiovascular function compared with placebo? Does Sacha Inchi-CoQ10 supplementation improve blood pressure, cholesterol, blood sugar, inflammation, and oxidative stress? Is Sacha Inchi-CoQ10 supplementation safe and well tolerated?
Researchers will compare Sacha Inchi-CoQ10 supplementation with a placebo (a look-alike supplement that does not contain Sacha Inchi-CoQ10) to see whether the supplementation improves cardiovascular health.
Participants will:
Take Sacha Inchi-CoQ10 supplementation or placebo for 12 weeks Visit the study clinic for screening, baseline, week 6, and week 12 assessments Have cardiovascular assessments, including echocardiography and blood pressure measurements Provide blood samples to assess cholesterol, blood sugar, inflammation, and oxidative stress Have their weight, body composition, and other health measurements assessed Complete questionnaires about their diet, physical activity, and quality of life Record their supplement intake and any symptoms or side effects during the study
Read the detailed description
This is a 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating Sacha-Q10 Plus, a combined Sacha Inchi and Coenzyme Q10 (CoQ10) supplementation, among adults with increased cardiovascular risk or stable cardiovascular disease. The study will be conducted at Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia, with participant recruitment carried out primarily through the Family Medicine Clinic.
Sacha Inchi (Plukenetia volubilis) is a natural source of essential fatty acids, particularly omega-3 fatty acids such as alpha-linolenic acid (ALA), as well as omega-6 and omega-9 fatty acids. Coenzyme Q10 is a mitochondrial antioxidant involved in cellular energy production and antioxidant defence. The combination is proposed to target multiple pathways involved in cardiovascular disease, including oxidative stress, inflammation, endothelial dysfunction, and cardiometabolic abnormalities.
Participants will be randomly assigned in a 1:1 ratio to receive either Sacha-Q10 Plus supplementation or a matching placebo. The intervention group will receive two softgels daily for 12 weeks. The intervention and placebo will be identical in appearance and packaging to maintain blinding among participants, investigators, and outcome assessors. Participants will be advised to maintain their usual diet and physical activity and to continue their prescribed medications without modification unless otherwise directed by their physician.
Study assessments will be conducted at screening, baseline (week 0), week 6, and week 12. Assessments will include clinical measurements, fasting blood sampling, blood pressure measurement, body composition assessment, and transthoracic echocardiography. Blood samples will be used to assess routine biochemical parameters, inflammatory biomarkers, and oxidative stress markers. Body composition will be assessed using bioelectrical impedance analysis, including phase angle measurement.
At the week 6 visit, participants will undergo interim safety and compliance monitoring, including assessment of adverse events, capsule counts, participant diaries, selected biochemical parameters, body composition, and blood pressure. At week 12, the baseline assessments will be repeated to evaluate changes following the intervention period. Dietary intake, physical activity, and health-related quality of life will also be assessed during the study period.
Compliance will be assessed through capsule counts and participant diaries. A compliance rate of at least 80% will be considered acceptable for inclusion in the per-protocol analysis. Safety and tolerability will be monitored throughout the study through active questioning, participant self-reporting, adverse event documentation, and clinical laboratory assessments, including renal and liver function tests. Adverse events will be documented according to their onset, duration, severity, frequency, outcome, and relationship to the study intervention. Serious adverse events will be reported and managed according to applicable institutional and regulatory requirements.
Data will be analysed according to the intention-to-treat principle, with per-protocol analysis conducted as a sensitivity analysis. Appropriate statistical methods will be used to compare outcomes between the intervention and placebo groups, including analysis of covariance for post-intervention comparisons and linear mixed-effects models or repeated measures analysis for outcomes assessed at multiple time points.
- Being tested
- Sacha-Q10 Plus, Placebo
- Keywords
- Sacha Inchi, Coenzyme Q10, Cardiovascular Disease, Endothelial Function, Oxidative Stress, Inflammation, Nutraceutical, Randomized Controlled Trial, Cardiovascular Risk
- Medical subject headings
- Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacha-Q10 PlusDietary supplement
Participants assigned to the intervention arm will receive Sacha Inchi-Coenzyme Q10 softgel supplementation, 2 softgels daily for 12 weeks.
PlaceboDietary supplement
Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sacha Inchi-CoQ10 supplementation Group | Experimental | Participants assigned to this arm will receive Sacha Inchi-CoQ10 softgel supplementation, 2 softgels daily for 12 weeks. Receives: Dietary Supplement: Sacha-Q10 Plus |
| Placebo Group | Placebo comparator | Participants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial-Related Cardiovascular Function Assessed by Transthoracic Echocardiography from Baseline to 12 Weeks
Parameters measured in this outcome:
- LV ventricular function (%)
- Myocardial Performance Index (Tei Index)
- Left Ventricular End-Diastolic Diameter (mm)
- Septal thickness (mm)
- Wall thickness (mm)
Measured: Assessed at baseline and Week 12 of the 12-week intervention period.
Secondary outcomes (1)
Change from Baseline in Cardiometabolic, Inflammatory and Oxidative Stress Biomarkers, Body Composition, and Safety and Compliance Assessment at Week 12
Parameters measured:
Cardiometabolic Markers:
Blood Pressure (mmHg) Total Cholesterol (mmol/L) HbA1c (%)
Inflammatory Biomarkers:
High-Sensitivity C-Reactive Protein (hsCRP) (mg/L) Interleukin-6 (IL-6) (pg/mL) Tumor Necrosis Factor-Alpha (TNF-α) (pg/mL) Matrix Metalloproteinase-3 (MMP-3) (ng/mL)
Oxidative Stress Biomarkers:
Superoxide Dismutase (SOD) (U/mL) Glutathione Peroxidase (GPx) (U/mL) Catalase Activity (U/mL) Lipid Peroxidation (LPO) (nmol/mL)
Anthropometry and Body Composition:
BMI (kg/m²) Waist Circumference (cm) Body Composition (%)
Safety:
Number of Participants Experiencing Adverse Events Change From Baseline in Serum Creatinine at Week 12 (µmol/L) Change From Baseline in Liver Function Test Parameters at Week 12 ( U/L)
Compliance:
Percentage of Prescribed Study Capsules Consumed During the 12-Week Intervention Period (%)
Measured: Baseline, Week 4, Week 8, and Week 12 of the 12-week intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease (CVD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pengajar Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792005
- Sponsor's protocol ID
- Sacha-Q10
- Acronym
- Sacha-Q10
- Status last verified
- Jun 2026
- First submitted
- 24 May 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available because the informed consent obtained from participants does not include permission for unrestricted data sharing.
Publications
Stark BA, DeCleene NK, Desai EC, Hsu JM, Johnson CO, Lara-Castor L, et al. Global, Regional, and National Burden of Cardiovascular Diseases and Risk Factors in 204 Countries and Territories, 1990-2023. J Am Coll Cardiol. 2025 Dec 2;86(22):2167-243. doi:10.1016/J.JACC.2025.08.015 PubMed PMID: 40990886. Department of Statistics Malaysia [Internet]. [cited 2026 Apr 12]. Available from: https://www.dosm.gov.my/portal-main/release-content/statistics-on-causes-of-death-malaysia-2025 Wan KS, Mohd Yusoff MF, Mat Rifin H, Chan WK, Alias N, Tham SW, et al. Prevalence of high 10-year cardiovascular risk among the general population in Malaysia and the associated factors: a nationwide community-based study in 2023. BMC Public Health. 2025 Dec 1;25(1):2706. doi:10.1186/S12889-025-23748-3 PubMed PMID: 40781610. Allende-Vigo MZ. Pathophysiologic mechanisms linking adipose tissue and cardiometabolic risk. Endocr Pract. 2010;16(4):692-8. doi:10.4158/EP09340.RA PubMed PMID: 20439246. Di Meo S, Venditti P. Evolution of the Knowledge of Free Radicals and Other Oxidants. Oxid Med Cell Longev. 2020;2020. doi:10.1155/2020/9829176 PubMed PMID: 32411336. Carter AM. Complement Activation: An Emerging Player in the Pathogenesis of Cardiovascular Disease. Scientifica (Cairo). 2012;2012:402783. doi:10.6064/2012/402783 PubMed PMID: 24278688. Goyal A, Tanwar B, Kumar Sihag M, Sharma V. Sacha inchi (Plukenetia volubilis L.): An emerging source of nutrients, omega-3 fatty acid and phytochemicals. Food Chem. 2022 Mar 30;373:131459. doi:10.1016/J.FOODCHEM.2021.131459 PubMed PMID: 34731811.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sacha Inchi-CoQ10 Supplementation on Endothelial-related Cardiovascular Function, Cardiometabolic Risk Factors, and Inflammatory Biomarkers Among Adults at Increased Cardiovascular Risk: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07792005
- Acronym / sponsor ID
- Sacha-Q10 / Sacha-Q10
- Keywords
- Sacha Inchi, Coenzyme Q10, Cardiovascular Disease, Endothelial Function, Oxidative Stress, Inflammation, Nutraceutical, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Pengajar Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Aug 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.
The goal of this clinical trial is to learn if Sacha Inchi-CoQ10 supplementation can improve cardiovascular health in adults who have an increased risk of cardiovascular disease. The study will also learn about the safety and tolerability of Sacha Inchi-CoQ10 supplementation.
The main questions it aims to answer are:
Does Sacha Inchi-CoQ10 supplementation improve cardiovascular function compared with placebo? Does Sacha Inchi-CoQ10 supplementation improve blood pressure, cholesterol, blood sugar, inflammation, and oxidative stress? Is Sacha Inchi-CoQ10 supplementation safe and well tolerated?
Researchers will compare Sacha Inchi-CoQ10 supplementation with a placebo (a look-alike supplement that does not contain Sacha Inchi-CoQ10) to see whether the supplementation improves cardiovascular health.
Participants will:
Take Sacha Inchi-CoQ10 supplementation or placebo for 12 weeks Visit the study clinic for screening, baseline, week 6, and week 12 assessments Have cardiovascular assessments, including echocardiography and blood pressure measurements Provide blood samples to assess cholesterol, blood sugar, inflammation, and oxidative stress Have their weight, body composition, and other health measurements assessed Complete questionnaires about their diet, physical activity, and quality of life Record their supplement intake and any symptoms or side effects during the study
Detailed description
This is a 12-week, randomized, double-blind, placebo-controlled clinical trial evaluating Sacha-Q10 Plus, a combined Sacha Inchi and Coenzyme Q10 (CoQ10) supplementation, among adults with increased cardiovascular risk or stable cardiovascular disease. The study will be conducted at Hospital Sultan Abdul Aziz Shah (HSAAS), Universiti Putra Malaysia, with participant recruitment carried out primarily through the Family Medicine Clinic.
Sacha Inchi (Plukenetia volubilis) is a natural source of essential fatty acids, particularly omega-3 fatty acids such as alpha-linolenic acid (ALA), as well as omega-6 and omega-9 fatty acids. Coenzyme Q10 is a mitochondrial antioxidant involved in cellular energy production and antioxidant defence. The combination is proposed to target multiple pathways involved in cardiovascular disease, including oxidative stress, inflammation, endothelial dysfunction, and cardiometabolic abnormalities.
Participants will be randomly assigned in a 1:1 ratio to receive either Sacha-Q10 Plus supplementation or a matching placebo. The intervention group will receive two softgels daily for 12 weeks. The intervention and placebo will be identical in appearance and packaging to maintain blinding among participants, investigators, and outcome assessors. Participants will be advised to maintain their usual diet and physical activity and to continue their prescribed medications without modification unless otherwise directed by their physician.
Study assessments will be conducted at screening, baseline (week 0), week 6, and week 12. Assessments will include clinical measurements, fasting blood sampling, blood pressure measurement, body composition assessment, and transthoracic echocardiography. Blood samples will be used to assess routine biochemical parameters, inflammatory biomarkers, and oxidative stress markers. Body composition will be assessed using bioelectrical impedance analysis, including phase angle measurement.
At the week 6 visit, participants will undergo interim safety and compliance monitoring, including assessment of adverse events, capsule counts, participant diaries, selected biochemical parameters, body composition, and blood pressure. At week 12, the baseline assessments will be repeated to evaluate changes following the intervention period. Dietary intake, physical activity, and health-related quality of life will also be assessed during the study period.
Compliance will be assessed through capsule counts and participant diaries. A compliance rate of at least 80% will be considered acceptable for inclusion in the per-protocol analysis. Safety and tolerability will be monitored throughout the study through active questioning, participant self-reporting, adverse event documentation, and clinical laboratory assessments, including renal and liver function tests. Adverse events will be documented according to their onset, duration, severity, frequency, outcome, and relationship to the study intervention. Serious adverse events will be reported and managed according to applicable institutional and regulatory requirements.
Data will be analysed according to the intention-to-treat principle, with per-protocol analysis conducted as a sensitivity analysis. Appropriate statistical methods will be used to compare outcomes between the intervention and placebo groups, including analysis of covariance for post-intervention comparisons and linear mixed-effects models or repeated measures analysis for outcomes assessed at multiple time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacha Inchi-CoQ10 supplementation Group | Experimental | Dietary Supplement: Sacha-Q10 PlusParticipants assigned to this arm will receive Sacha Inchi-CoQ10 softgel supplementation, 2 softgels daily for 12 weeks. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboParticipants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 40 to 75 years.
- Male or female.
- Have one or more cardiovascular risk factors or stable cardiovascular disease, including:
- Hypertension; Dyslipidaemia; Controlled diabetes mellitus; or High cardiovascular risk, defined as Framingham Risk Score ≥10%.
- Able to provide written informed consent.
Key exclusion criteria (9 listed)
- Unstable cardiovascular disease.
- Severe renal impairment.
- Severe hepatic impairment.
- Active malignancy.
- Pregnant or lactating women.
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 |
|---|---|---|
| Sacha-Q10 PlusParticipants assigned to the intervention arm will receive Sacha Inchi-Coenzyme Q10 softgel supplementation, 2 softgels daily for 12 weeks. | Dietary supplement | Sacha Inchi-CoQ10 supplementation Group |
| PlaceboParticipants assigned to this arm will receive matching placebo softgels, 2 softgels daily for 12 weeks. | Dietary supplement | Placebo Group |
Primary outcome
Change in Endothelial-Related Cardiovascular Function Assessed by Transthoracic Echocardiography from Baseline to 12 Weeks
Time frame: Assessed at baseline and Week 12 of the 12-week intervention period.
Parameters measured in this outcome: * LV ventricular function (%) * Myocardial Performance Index (Tei Index) * Left Ventricular End-Diastolic Diameter (mm) * Septal thickness (mm) * Wall thickness (mm)
1 secondary outcome
Change from Baseline in Cardiometabolic, Inflammatory and Oxidative Stress Biomarkers, Body Composition, and Safety and Compliance Assessment at Week 12
Time frame: Baseline, Week 4, Week 8, and Week 12 of the 12-week intervention period.
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 28 Aug 2026.
- BackgroundStark BA, DeCleene NK, Desai EC, Hsu JM, Johnson CO, Lara-Castor L, et al. Global, Regional, and National Burden of Cardiovascular Diseases and Risk Factors in 204 Countries and Territories, 1990-2023. J Am Coll Cardiol. 2025 Dec 2;86(22):2167-243. doi:10.1016/J.JACC.2025.08.015 PubMed PMID: 40990886. Department of Statistics Malaysia [Internet]. [cited 2026 Apr 12]. Available from: https://www.dosm.gov.my/portal-main/release-content/statistics-on-causes-of-death-malaysia-2025 Wan KS, Mohd Yusoff MF, Mat Rifin H, Chan WK, Alias N, Tham SW, et al. Prevalence of high 10-year cardiovascular risk among the general population in Malaysia and the associated factors: a nationwide community-based study in 2023. BMC Public Health. 2025 Dec 1;25(1):2706. doi:10.1186/S12889-025-23748-3 PubMed PMID: 40781610. Allende-Vigo MZ. Pathophysiologic mechanisms linking adipose tissue and cardiometabolic risk. Endocr Pract. 2010;16(4):692-8. doi:10.4158/EP09340.RA PubMed PMID: 20439246. Di Meo S, Venditti P. Evolution of the Knowledge of Free Radicals and Other Oxidants. Oxid Med Cell Longev. 2020;2020. doi:10.1155/2020/9829176 PubMed PMID: 32411336. Carter AM. Complement Activation: An Emerging Player in the Pathogenesis of Cardiovascular Disease. Scientifica (Cairo). 2012;2012:402783. doi:10.6064/2012/402783 PubMed PMID: 24278688. Goyal A, Tanwar B, Kumar Sihag M, Sharma V. Sacha inchi (Plukenetia volubilis L.): An emerging source of nutrients, omega-3 fatty acid and phytochemicals. Food Chem. 2022 Mar 30;373:131459. doi:10.1016/J.FOODCHEM.2021.131459 PubMed PMID: 34731811.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available because the informed consent obtained from participants does not include permission for unrestricted data sharing.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Sacha-Q10 Plus in people with Cardiovascular Disease (CVD) and Elevated Cardiovascular Risk, run by Hospital Pengajar Universiti Putra Malaysia.
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 9 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Prof. Dr. Chan Yoke Mun (+60 16-391 6589, cym@upm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endothelial-Related Cardiovascular Function Assessed by Transthoracic Echocardiography from Baseline to 12 Weeks (time frame: Assessed at baseline and Week 12 of the 12-week intervention period.). 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 NCT07792005, which also lists 1 linked publication.
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 28 Aug 2026.