Diabetes Mellitus (DM)GRPC-DMNCT07268781
Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients
A study testing Golden Rice cookies with Piper crocatum Extract in people with Diabetes Mellitus (DM) and Dyslipidemia, run by Hasanuddin University at 2 sites in Indonesia.
Trial summary
People with diabetes often experience abnormal blood fat levels, known as dyslipidemia, which increase the risk of heart disease and stroke. The aim of the study, researchers are exploring a natural and practical solution through a healthy snack in the form of cookies. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Diabetes Mellitus (DM), Dyslipidemia, Lipid Profile
- What is being tested?
- Golden Rice cookies with Piper crocatum Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 2 sitesIndonesia
- Study dates
- 20 Oct 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-59 years.
- Patients diagnosed with Type 2 Diabetes Mellitus based on medical records at Tambu Primary Health Center.
- Able to read and communicate effectively with healthcare staff.
- Permanent resident in the Tambu area.
- Willing to participate in the intervention and follow-up evaluations for the duration of the study.
Who cannot join
- Pregnant or breastfeeding women, or those currently undergoing a pregnancy program.
- Patients with mental health disorders.
- Patients with severe comorbidities affecting lipid metabolism, such as chronic kidney disease (CKD), hepatitis, congestive heart failure, stroke, or acute coronary syndrome within the past 3 months.
- Patients who have consumed herbal supplements or high-dose antioxidants within the last month.
- Patients with severe gastrointestinal disorders, such as chronic diarrhea.
- Patients with a history of allergy to any ingredients used in the study intervention.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Tambu Primary Health Center (Puskesmas Tambu)
Donggala, Central Sulawesi, 94355
RSUD Anutapura Palu
Palu, Central Sulawesi, 94111
About this study
Official title: The Effect of Golden Rice Cookies With Piper Crocatum Extract on Lipid Profile Control in Patients With Diabetes Mellitus
People with diabetes often experience abnormal blood fat levels, known as dyslipidemia, which increase the risk of heart disease and stroke. The aim of the study, researchers are exploring a natural and practical solution through a healthy snack in the form of cookies. These cookies are made from Golden Rice, which is rich in beta-carotene as a natural antioxidant, and Piper crocatum (red betel leaf) extract, which contains polyphenols and flavonoids that may help lower cholesterol, reduce inflammation, and protect blood vessels. In this study, patients with diabetes will consume the cookies for 28 days, and their blood fat levels will be measured before and after the intervention. The results will then be compared with those of a control group who receive the Golden rice cookies without piper crocatum extract. This research aims to show that Golden Rice with Piper crocatum extract cookies can reduce bad cholesterol and triglycerides, increase good cholesterol, and serve as a safe, affordable, and acceptable food option to support daily diabetes care. If successful, this approach may offer patients and families a simple way to help prevent complications and improve quality of life, alongside regular treatment and lifestyle changes.
Read the detailed description
This clinical trial evaluates the effect of Golden Rice cookies enriched with Piper crocatum (red betel leaf) extract on lipid profile control in patients with type 2 diabetes mellitus. The intervention is designed as a short-term, food-based strategy to complement existing diabetes management by integrating functional food into daily dietary practice.
The rationale for this approach is based on evidence that beta-carotene from Golden Rice and polyphenols from Piper crocatum exert antioxidant, anti-inflammatory, and lipid-lowering activities. Combining these bioactive compounds in the form of cookies provides a culturally acceptable, affordable, and practical dietary intervention. The cookie format was selected due to its high acceptance, ease of distribution, and potential to improve adherence compared with capsule or extract preparations.
This trial uses a controlled pre-post design to compare changes in lipid biomarkers between the intervention and control groups over 28 days. Key outcomes include serum levels of LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol. The study also explores potential synergistic effects on oxidative stress and inflammatory processes associated with dyslipidemia in diabetes.
By translating the concept of functional food into a practical dietary item, this study aims to generate evidence for its role as an adjunctive therapy in diabetes care. Findings are expected to inform future dietary guidelines and nursing interventions, particularly in community-based settings where accessibility, patient adherence, and cost-effectiveness are critical considerations.
- Conditions
- Diabetes Mellitus (DM), Dyslipidemia, Lipid Profile, Functional Food, Nutritional Intervention, Cardiovascular Risk Factor
- Being tested
- Golden Rice cookies with Piper crocatum Extract, Placebo Cookies (Control)
- Medical subject headings
- Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golden Rice cookies with Piper crocatum ExtractDietary supplement
Golden Rice cookies enriched with Piper crocatum extract, formulated as a functional food containing β-carotene and polyphenols with antioxidant, anti-inflammatory, and lipid-modulating properties. Participants will consume the cookies daily for 28 consecutive days in addition to their standard diabetes management. This intervention is designed to improve lipid metabolism and reduce dyslipidemia in patients with Diabetes Mellitus.
Placebo Cookies (Control)Dietary supplement
Placebo cookies without Golden Rice or Piper crocatum extract, identical in appearance, taste, and packaging to the intervention cookies. Participants will consume placebo cookies daily for 28 consecutive days along with their standard diabetes management. This placebo is used to maintain participant blinding and provide a valid comparison.
| Study group | Role | What they receive |
|---|---|---|
| Golden Rice cookies With Piper Crocatum extract | Experimental | Participants will receive Golden Rice cookies enriched with Piper crocatum extract as a daily dietary supplement for 28 consecutive days. The cookies are formulated as a functional food, providing β-carotene from Golden Rice and polyphenols from Piper crocatum, which have antioxidant, anti-inflammatory, and lipid-modulating properties. The intervention aims to improve lipid metabolism by reducing total cholesterol, LDL, and triglycerides while increasing HDL levels in patients with Diabetes Mellitus. Receives: Dietary Supplement: Golden Rice cookies with Piper crocatum Extract |
| Active Comparator (Control) | Active comparator | Participants will receive Golden Rice cookies without Piper crocatum extract, identical in appearance and packaging to the intervention cookies, for 28 consecutive days. This control is designed to maintain participant blinding and to serve as a comparison for evaluating the specific effects of Piper crocatum extract on lipid profile outcomes. Receives: Dietary Supplement: Placebo Cookies (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total Cholesterol (mg/dL)
Serum total cholesterol will be measured to assess the effect of Golden Rice cookies enriched with Piper crocatum extract on lipid control in patients with diabetes mellitus.
Measured: Baseline (Day 0) and after 28 days of intervention
Change in Low-Density Lipoprotein (LDL) Cholesterol (mg/dL)
LDL cholesterol levels will be measured to evaluate changes following the 28-day intervention
Measured: Baseline (Day 0) to Day 28
Change in High-Density Lipoprotein (HDL) Cholesterol (mg/dL)
HDL cholesterol levels will be measured to determine improvement in protective lipid fractions.
Measured: Baseline (Day 0) to Day 28
Change in Triglycerides (mg/dL)
Serum triglyceride levels will be measured to assess metabolic lipid response to the intervention.
Measured: Baseline (Day 0) to Day 28
Secondary outcomes (2)
Participant adherence Rate (%)
Daily adherence to the assigned cookie regimen will be monitored using participant self-report checklists and confirmed by the count of returned empty packaging during weekly follow-up visits. Adherence will be reported as the percentage of prescribed doses consumed over the 28-day intervention.
Measured: Baseline to Day 28
Incidence of Adverse Events (Number of Participants)
All adverse events and signs of intolerance (e.g., gastrointestinal symptoms, allergic reactions) potentially associated with the intervention will be documented throughout the study period. Events will be classified by type, severity, onset, duration, and relationship to the study product. Results will be reported as the number and percentage of participants experiencing at least one adverse event.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start20 Oct 2025
- Primary completion30 Nov 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus (DM)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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is an interventional clinical trial with a parallel-group design to evaluate the effect of Golden Rice cookies enriched with Piper crocatum extract on lipid profile control in patients with Type 2 Diabetes Mellitus. Participants will be divided into two groups: the intervention group, which will receive Golden Rice cookies containing Piper crocatum extract for 28 consecutive days, and the control group, which will receive standard care (placebo) without the functional food intervention. The study follows a pre-test and post-test control group design, where lipid profile parameters including total cholesterol, LDL, HDL, and triglycerides will be assessed at baseline and after the 28-day intervention period. The allocation is randomized, while masking is not applied due to the nature of the dietary intervention. The primary purpose of this study is treatment, aiming to improve lipid metabolism, reduce dyslipidemia, and prevent cardiovascular complications in patients with
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Altje Suwardi Abram, Hasanuddin University
- Investigators
- ANDINA SETYAWATI, PhD, S.Kep., Ns., M.Kep., Study director, Hasanuddin University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268781
- Sponsor's protocol ID
- UH2507094
- Acronym
- GRPC-DM
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) for this study.
Publications
Setyawati A, Saleh A, Tahir T, Yusuf S, Syahrul S, Aminuddin A, Raihan M, Jafar N, Hamzah H, Arfian N. Matrix Metalloproteinase-9 Testing of Golden Rice Cookies With Piper Crocatum Active Extract for Preventing Foot Ulcers in Patients With Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 29;13:e49940. doi: 10.2196/49940.
PubMed 38422498https://jppres.com/jppres/pdf/vol13/jppres25.2499_13.6.1847.pdf
Setyawati A, Wahyuningsih MSH, Nugrahaningsih DAA, Effendy C, Fneish F, Fortwengel G. Piper crocatum Ruiz & Pav. ameliorates wound healing through p53, E-cadherin and SOD1 pathways on wounded hyperglycemia fibroblasts. Saudi J Biol Sci. 2021 Dec;28(12):7257-7268. doi: 10.1016/j.sjbs.2021.08.039. Epub 2021 Aug 19.
PubMed 34867030Abram AS, Setyawati A, Irwan AM. Short-Term Effects of Golden Rice Cookies Enriched With Piper crocatum Extract on Lipid Profiles in Adults With Diabetes: A Quasi-Experimental Study. Chronic Dis Transl Med. 2026 Oct 29:10.1002/cdt3.70075. doi: 10.1002/cdt3.70075. Online ahead of print.
PubMed 42959413
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Golden Rice Cookies With Piper Crocatum Extract on Lipid Profile Control in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07268781
- Acronym / sponsor ID
- GRPC-DM / UH2507094
- Conditions
- Diabetes Mellitus (DM), Dyslipidemia, Lipid Profile, Functional Food, Nutritional Intervention, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 8 Dec 2025 (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.
People with diabetes often experience abnormal blood fat levels, known as dyslipidemia, which increase the risk of heart disease and stroke. The aim of the study, researchers are exploring a natural and practical solution through a healthy snack in the form of cookies. These cookies are made from Golden Rice, which is rich in beta-carotene as a natural antioxidant, and Piper crocatum (red betel leaf) extract, which contains polyphenols and flavonoids that may help lower cholesterol, reduce inflammation, and protect blood vessels. In this study, patients with diabetes will consume the cookies for 28 days, and their blood fat levels will be measured before and after the intervention. The results will then be compared with those of a control group who receive the Golden rice cookies without piper crocatum extract. This research aims to show that Golden Rice with Piper crocatum extract cookies can reduce bad cholesterol and triglycerides, increase good cholesterol, and serve as a safe, affordable, and acceptable food option to support daily diabetes care. If successful, this approach may offer patients and families a simple way to help prevent complications and improve quality of life, alongside regular treatment and lifestyle changes.
Detailed description
This clinical trial evaluates the effect of Golden Rice cookies enriched with Piper crocatum (red betel leaf) extract on lipid profile control in patients with type 2 diabetes mellitus. The intervention is designed as a short-term, food-based strategy to complement existing diabetes management by integrating functional food into daily dietary practice.
The rationale for this approach is based on evidence that beta-carotene from Golden Rice and polyphenols from Piper crocatum exert antioxidant, anti-inflammatory, and lipid-lowering activities. Combining these bioactive compounds in the form of cookies provides a culturally acceptable, affordable, and practical dietary intervention. The cookie format was selected due to its high acceptance, ease of distribution, and potential to improve adherence compared with capsule or extract preparations.
This trial uses a controlled pre-post design to compare changes in lipid biomarkers between the intervention and control groups over 28 days. Key outcomes include serum levels of LDL cholesterol, HDL cholesterol, triglycerides, and total cholesterol. The study also explores potential synergistic effects on oxidative stress and inflammatory processes associated with dyslipidemia in diabetes.
By translating the concept of functional food into a practical dietary item, this study aims to generate evidence for its role as an adjunctive therapy in diabetes care. Findings are expected to inform future dietary guidelines and nursing interventions, particularly in community-based settings where accessibility, patient adherence, and cost-effectiveness are critical considerations.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is an interventional clinical trial with a parallel-group design to evaluate the effect of Golden Rice cookies enriched with Piper crocatum extract on lipid profile control in patients with Type 2 Diabetes Mellitus. Participants will be divided into two groups: the intervention group, which will receive Golden Rice cookies containing Piper crocatum extract for 28 consecutive days, and the control group, which will receive standard care (placebo) without the functional food intervention. The study follows a pre-test and post-test control group design, where lipid profile parameters including total cholesterol, LDL, HDL, and triglycerides will be assessed at baseline and after the 28-day intervention period. The allocation is randomized, while masking is not applied due to the nature of the dietary intervention. The primary purpose of this study is treatment, aiming to improve lipid metabolism, reduce dyslipidemia, and prevent cardiovascular complications in patients with
| Arm | Type | Receives |
|---|---|---|
| Golden Rice cookies With Piper Crocatum extract | Experimental | Dietary Supplement: Golden Rice cookies with Piper crocatum ExtractParticipants will receive Golden Rice cookies enriched with Piper crocatum extract as a daily dietary supplement for 28 consecutive days. The cookies are formulated as a functional food, providing β-carotene from Golden Rice and polyphenols from Piper crocatum, which have antioxidant, anti-inflammatory, and lipid-modulating properties. The intervention aims to improve lipid metabolism by reducing total cholesterol, LDL, and triglycerides while increasing HDL levels in patients with Diabetes Mellitus. |
| Active Comparator (Control) | Active comparator | Dietary Supplement: Placebo Cookies (Control)Participants will receive Golden Rice cookies without Piper crocatum extract, identical in appearance and packaging to the intervention cookies, for 28 consecutive days. This control is designed to maintain participant blinding and to serve as a comparison for evaluating the specific effects of Piper crocatum extract on lipid profile outcomes. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-59 years.
- Patients diagnosed with Type 2 Diabetes Mellitus based on medical records at Tambu Primary Health Center.
- Able to read and communicate effectively with healthcare staff.
- Permanent resident in the Tambu area.
- Willing to participate in the intervention and follow-up evaluations for the duration of the study.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women, or those currently undergoing a pregnancy program.
- Patients with mental health disorders.
- Patients with severe comorbidities affecting lipid metabolism, such as chronic kidney disease (CKD), hepatitis, congestive heart failure, stroke, or acute coronary syndrome within the past 3 months.
- Patients who have consumed herbal supplements or high-dose antioxidants within the last month.
- Patients with severe gastrointestinal disorders, such as chronic diarrhea.
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 |
|---|---|---|
| Golden Rice cookies with Piper crocatum ExtractGolden Rice cookies enriched with Piper crocatum extract, formulated as a functional food containing β-carotene and polyphenols with antioxidant, anti-inflammatory, and lipid-modulating properties. Participants will consume the cookies daily for 28 consecutive days in addition to their standard diabetes management. This intervention is designed to improve lipid metabolism and reduce dyslipidemia in patients with Diabetes Mellitus. | Dietary supplement | Golden Rice cookies With Piper Crocatum extract |
| Placebo Cookies (Control)Placebo cookies without Golden Rice or Piper crocatum extract, identical in appearance, taste, and packaging to the intervention cookies. Participants will consume placebo cookies daily for 28 consecutive days along with their standard diabetes management. This placebo is used to maintain participant blinding and provide a valid comparison. | Dietary supplement | Active Comparator (Control) |
Primary outcome
Change in total Cholesterol (mg/dL)
Time frame: Baseline (Day 0) and after 28 days of intervention
Serum total cholesterol will be measured to assess the effect of Golden Rice cookies enriched with Piper crocatum extract on lipid control in patients with diabetes mellitus.
Change in Low-Density Lipoprotein (LDL) Cholesterol (mg/dL)
Time frame: Baseline (Day 0) to Day 28
LDL cholesterol levels will be measured to evaluate changes following the 28-day intervention
Change in High-Density Lipoprotein (HDL) Cholesterol (mg/dL)
Time frame: Baseline (Day 0) to Day 28
HDL cholesterol levels will be measured to determine improvement in protective lipid fractions.
Change in Triglycerides (mg/dL)
Time frame: Baseline (Day 0) to Day 28
Serum triglyceride levels will be measured to assess metabolic lipid response to the intervention.
2 secondary outcomes
Participant adherence Rate (%)
Time frame: Baseline to Day 28
Incidence of Adverse Events (Number of Participants)
Time frame: Baseline to Day 28
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 16 Sep 2026.
- Background: PubMed 38422498Setyawati A, Saleh A, Tahir T, Yusuf S, Syahrul S, Aminuddin A, Raihan M, Jafar N, Hamzah H, Arfian N. Matrix Metalloproteinase-9 Testing of Golden Rice Cookies With Piper Crocatum Active Extract for Preventing Foot Ulcers in Patients With Diabetes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 29;13:e49940. doi: 10.2196/49940.
- Results publicationhttps://jppres.com/jppres/pdf/vol13/jppres25.2499_13.6.1847.pdf
- Results publication: PubMed 34867030Setyawati A, Wahyuningsih MSH, Nugrahaningsih DAA, Effendy C, Fneish F, Fortwengel G. Piper crocatum Ruiz & Pav. ameliorates wound healing through p53, E-cadherin and SOD1 pathways on wounded hyperglycemia fibroblasts. Saudi J Biol Sci. 2021 Dec;28(12):7257-7268. doi: 10.1016/j.sjbs.2021.08.039. Epub 2021 Aug 19.
- Derived from this study: PubMed 42959413Abram AS, Setyawati A, Irwan AM. Short-Term Effects of Golden Rice Cookies Enriched With Piper crocatum Extract on Lipid Profiles in Adults With Diabetes: A Quasi-Experimental Study. Chronic Dis Transl Med. 2026 Oct 29:10.1002/cdt3.70075. doi: 10.1002/cdt3.70075. Online ahead of print.
- Official website of the Faculty of Nursing, Universitas Hasanuddin.Link provided by the sponsor.
- Universitas Hasanuddin official website.Link provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) for this study.
Related trials for Diabetes Mellitus (DM)
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
Active, not recruitingObservational study
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (DM)
RecruitingObservational study
Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes
Diabetes (DM)
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.
ANDINA SETYAWATI, PhD, S.Kep., Ns., M.Kep. study director
Hasanuddin University, Faculty of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golden Rice cookies with Piper crocatum Extract in people with Diabetes Mellitus (DM) and Dyslipidemia, run by Hasanuddin University at 2 sites in Indonesia.
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 5 inclusion and 6 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Change in total Cholesterol (mg/dL) (time frame: Baseline (Day 0) and after 28 days of intervention). The study lists 4 primary outcomes in all. 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 NCT07268781, which also lists 4 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 16 Sep 2026.