DyslipidemiasDNS SoymilkNCT07175766
Dachundou No Sugar Added Soymilk for Lipid Modulation
A study testing Dachundou No Sugar Added Soymilk in people with Dyslipidemias and Hypercholesterolemia, run by National Taiwan Sport University at 1 site in Taiwan.
Trial summary
Cardiovascular disease is one of the leading causes of death worldwide, and high cholesterol is a major risk factor. Diet is known to play an important role in managing blood lipids. Soy milk is a common plant-based drink rich in protein and isoflavones, which may help lower cholesterol and improve heart health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Hypercholesterolemia, Cardiovascular Diseases
- What is being tested?
- Dachundou No Sugar Added Soymilk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years
- Fasting total cholesterol (TC) ≥200 mg/dL at both screening (week -2) and baseline (week 0)
- Non-smokers
- No alcohol abuse
- Able and willing to comply with study procedures, dietary restrictions, and follow-up visits
Who cannot join
- Pregnant or lactating women
- Menopausal or postmenopausal women
- Diagnosed with chronic diseases under medical treatment (e.g., hypertension, hyperlipidemia, diabetes, liver, kidney, gastrointestinal, cardiovascular disease, cancer)
- Use of dietary supplements or drugs affecting lipid metabolism within 1 month before study entry or during the study
- Cognitive impairment preventing informed consent or protocol compliance
- History of allergy to soy milk, oats, or gluten-containing products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Lipid-Modulating and Health Benefits of Dachundou No Sugar Added Soymilk in Humans
Cardiovascular disease is one of the leading causes of death worldwide, and high cholesterol is a major risk factor. Diet is known to play an important role in managing blood lipids. Soy milk is a common plant-based drink rich in protein and isoflavones, which may help lower cholesterol and improve heart health.
This clinical trial will evaluate whether daily consumption of Dachundou No Sugar Added Soymilk can help reduce cholesterol levels in adults with elevated total cholesterol (≥200 mg/dL). A total of 50 participants aged 18-65 will be recruited. Participants will drink two bottles of soymilk per day (375 mL each, total 750 mL) for 8 weeks.
During the study, researchers will measure cholesterol, blood pressure, body weight, waist circumference, and other health indicators. The results will help determine whether Dachundou No Sugar Added Soymilk can improve blood lipid levels and contribute to cardiovascular health.
Read the detailed description
Cardiovascular disease remains a leading cause of morbidity and mortality worldwide, with dyslipidemia being one of the most important risk factors. Dietary interventions, such as plant-based proteins and bioactive compounds, have been shown to improve lipid profiles and reduce cardiovascular risk. Soy milk is widely consumed in Asia and contains soy protein and isoflavones, which have antioxidant, anti-inflammatory, and lipid-regulating effects.
Previous studies suggest that soy protein may lower total cholesterol and LDL-C through inhibition of HMG-CoA reductase and upregulation of LDL receptor expression, while soy isoflavones may enhance lipid metabolism and endothelial function through estrogen-like actions.
This trial aims to evaluate the lipid-lowering efficacy of Dachundou No Sugar Added Soymilk in adults with fasting total cholesterol ≥200 mg/dL. A total of 50 participants, aged 18-65 years, non-smokers, without alcohol abuse, and otherwise healthy, will be enrolled. All participants will consume two bottles of soymilk per day (375 mL each; total 750 mL) for 8 consecutive weeks.
Assessments will be performed at baseline (week -2 and week 0), during the intervention (week 4 and week 8), and post-intervention (week 10). Measurements include anthropometrics (height, weight, waist circumference, blood pressure), blood biochemistry (lipid profile, glucose, liver and kidney function), oxidative stress (oxidized LDL via TBARS), and lifestyle factors (dietary records and physical activity questionnaires).
The primary outcome is the change in total cholesterol from baseline to week 8. Secondary outcomes include changes in LDL-C, HDL-C, triglycerides, oxidized LDL, liver/kidney function, and anthropometric indices. The findings will provide evidence on whether Dachundou No Sugar Added Soymilk can serve as a dietary intervention to improve blood lipid levels and promote cardiovascular health.
- Conditions
- Dyslipidemias, Hypercholesterolemia, Cardiovascular Diseases
- Being tested
- Dachundou No Sugar Added Soymilk
- Keywords
- Soy milk, Dachundou, No sugar added soymilk, Cholesterol, Total cholesterol, LDL cholesterol, HDL cholesterol, Lipid metabolism, Functional food, Cardiovascular health
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dachundou No Sugar Added SoymilkDietary supplement
Also called Unsweetened Dachundou Soymilk
Participants will consume two bottles of Dachundou No Sugar Added Soymilk daily (375 mL each; total 750 mL per day) for 8 consecutive weeks. The product is packaged in 375 mL cartons and made from non-GMO soybeans, containing approximately 4.2 g of soy protein per 100 mL. The soymilk is unsweetened and stored at 0-7°C.
| Study group | Role | What they receive |
|---|---|---|
| Soymilk Intervention | Experimental | Participants will consume two bottles of Dachundou No Sugar Added Soymilk daily (375 mL each; total 750 mL per day) for 8 consecutive weeks. Assessments will be performed at baseline (week -2 and week 0), during the intervention (week 4 and week 8), and post-intervention (week 10). Receives: Dietary Supplement: Dachundou No Sugar Added Soymilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total cholesterol (TC)
Serum total cholesterol concentration will be measured using an automated biochemical analyzer to evaluate the lipid-lowering efficacy of Dachundou No Sugar Added Soymilk.
Measured: Baseline (week 0) to week 8
Secondary outcomes (12)
Change in LDL cholesterol (LDL-C)
LDL-C concentration measured by automated biochemical analyzer.
Measured: Baseline to week 8
Change in HDL cholesterol (HDL-C)
HDL-C concentration measured by automated biochemical analyzer.
Measured: Baseline to week 8
Change in triglycerides (TG)
Serum triglyceride concentration measured by automated biochemical analyzer.
Measured: Baseline to week 8
Change in oxidized LDL (TBARS assay)
Oxidative stress marker (TBARS values in LDL fraction).
Measured: Baseline to week 8
Change in body weight (kg)
Weight will be measured using a calibrated digital scale, with participants wearing light clothing and no shoes.
Measured: Baseline, week 4, week 8, week 10
Liver function markers (AST, ALT, γ-GT)
Serum liver enzymes assessed for safety.
Measured: Baseline and week 8
Kidney function markers (BUN, creatinine, uric acid)
Serum renal parameters assessed for safety.
Measured: Baseline and week 8
Change in dietary intake (kcal/day)
Dietary intake will be assessed using 3-day food records analyzed with nutrition analysis software to calculate average daily energy intake (kcal/day).
Measured: Baseline, week 4, week 8, week 10
Change in body mass index (BMI, kg/m²)
BMI will be calculated as weight in kilograms divided by height in meters squared.
Measured: Baseline, week 4, week 8, week 10
Change in waist circumference (cm)
Waist circumference will be measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, using a standard tape measure.
Measured: Baseline, week 4, week 8, week 10
Change in blood pressure (mmHg)
Systolic and diastolic blood pressure will be measured using an automated sphygmomanometer after 5 minutes seated rest.
Measured: Baseline, week 4, week 8, week 10
Change in physical activity level (IPAQ-SF score, MET-min/week)
Physical activity will be assessed using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Scores will be calculated as MET-minutes per week. Higher scores indicate greater physical activity levels.
Measured: Baseline, week 4, week 8, week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Sep 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
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 DyslipidemiasStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, open-label interventional study. All participants meeting the eligibility criteria will receive the same intervention: daily supplementation with Dachundou No Sugar Added Soymilk (2 bottles of 375 mL each; total 750 mL/day) for 8 consecutive weeks. No control or placebo group will be included. Outcomes will be assessed at baseline (week -2 and week 0), mid-intervention (week 4), end of intervention (week 8), and follow-up (week 10).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Chang Huang, National Taiwan Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175766
- Sponsor's protocol ID
- IRB-25-058-A2
- Other IDs
- 2025-Dachundou-IRB-25-058-A2
- Acronym
- DNS Soymilk
- Status last verified
- Apr 2026
- First submitted
- 2 Sep 2025
- Last updated
- 13 Apr 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 shared because the trial involves sensitive health-related data collected from human participants. Only aggregated and de-identified summary results will be published in scientific journals and conference presentations.
Publications
Ramdath DD, Padhi EM, Sarfaraz S, Renwick S, Duncan AM. Beyond the Cholesterol-Lowering Effect of Soy Protein: A Review of the Effects of Dietary Soy and Its Constituents on Risk Factors for Cardiovascular Disease. Nutrients. 2017 Mar 24;9(4):324. doi: 10.3390/nu9040324.
PubMed 28338639
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Lipid-Modulating and Health Benefits of Dachundou No Sugar Added Soymilk in Humans
- ClinicalTrials.gov ID
- NCT07175766
- Acronym / sponsor ID
- DNS Soymilk / IRB-25-058-A2
- Conditions
- Dyslipidemias, Hypercholesterolemia, Cardiovascular Diseases
- Keywords
- Soy milk, Dachundou, No sugar added soymilk, Cholesterol, Total cholesterol, LDL cholesterol, HDL cholesterol, Lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Taiwan Sport UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 16 Sep 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.
Cardiovascular disease is one of the leading causes of death worldwide, and high cholesterol is a major risk factor. Diet is known to play an important role in managing blood lipids. Soy milk is a common plant-based drink rich in protein and isoflavones, which may help lower cholesterol and improve heart health.
This clinical trial will evaluate whether daily consumption of Dachundou No Sugar Added Soymilk can help reduce cholesterol levels in adults with elevated total cholesterol (≥200 mg/dL). A total of 50 participants aged 18-65 will be recruited. Participants will drink two bottles of soymilk per day (375 mL each, total 750 mL) for 8 weeks.
During the study, researchers will measure cholesterol, blood pressure, body weight, waist circumference, and other health indicators. The results will help determine whether Dachundou No Sugar Added Soymilk can improve blood lipid levels and contribute to cardiovascular health.
Detailed description
Cardiovascular disease remains a leading cause of morbidity and mortality worldwide, with dyslipidemia being one of the most important risk factors. Dietary interventions, such as plant-based proteins and bioactive compounds, have been shown to improve lipid profiles and reduce cardiovascular risk. Soy milk is widely consumed in Asia and contains soy protein and isoflavones, which have antioxidant, anti-inflammatory, and lipid-regulating effects.
Previous studies suggest that soy protein may lower total cholesterol and LDL-C through inhibition of HMG-CoA reductase and upregulation of LDL receptor expression, while soy isoflavones may enhance lipid metabolism and endothelial function through estrogen-like actions.
This trial aims to evaluate the lipid-lowering efficacy of Dachundou No Sugar Added Soymilk in adults with fasting total cholesterol ≥200 mg/dL. A total of 50 participants, aged 18-65 years, non-smokers, without alcohol abuse, and otherwise healthy, will be enrolled. All participants will consume two bottles of soymilk per day (375 mL each; total 750 mL) for 8 consecutive weeks.
Assessments will be performed at baseline (week -2 and week 0), during the intervention (week 4 and week 8), and post-intervention (week 10). Measurements include anthropometrics (height, weight, waist circumference, blood pressure), blood biochemistry (lipid profile, glucose, liver and kidney function), oxidative stress (oxidized LDL via TBARS), and lifestyle factors (dietary records and physical activity questionnaires).
The primary outcome is the change in total cholesterol from baseline to week 8. Secondary outcomes include changes in LDL-C, HDL-C, triglycerides, oxidized LDL, liver/kidney function, and anthropometric indices. The findings will provide evidence on whether Dachundou No Sugar Added Soymilk can serve as a dietary intervention to improve blood lipid levels and promote cardiovascular health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, open-label interventional study. All participants meeting the eligibility criteria will receive the same intervention: daily supplementation with Dachundou No Sugar Added Soymilk (2 bottles of 375 mL each; total 750 mL/day) for 8 consecutive weeks. No control or placebo group will be included. Outcomes will be assessed at baseline (week -2 and week 0), mid-intervention (week 4), end of intervention (week 8), and follow-up (week 10).
| Arm | Type | Receives |
|---|---|---|
| Soymilk Intervention | Experimental | Dietary Supplement: Dachundou No Sugar Added SoymilkParticipants will consume two bottles of Dachundou No Sugar Added Soymilk daily (375 mL each; total 750 mL per day) for 8 consecutive weeks. Assessments will be performed at baseline (week -2 and week 0), during the intervention (week 4 and week 8), and post-intervention (week 10). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years
- Fasting total cholesterol (TC) ≥200 mg/dL at both screening (week -2) and baseline (week 0)
- Non-smokers
- No alcohol abuse
- Able and willing to comply with study procedures, dietary restrictions, and follow-up visits
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Menopausal or postmenopausal women
- Diagnosed with chronic diseases under medical treatment (e.g., hypertension, hyperlipidemia, diabetes, liver, kidney, gastrointestinal, cardiovascular disease, cancer)
- Use of dietary supplements or drugs affecting lipid metabolism within 1 month before study entry or during the study
- Cognitive impairment preventing informed consent or protocol compliance
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 |
|---|---|---|
| Dachundou No Sugar Added SoymilkAlso: Unsweetened Dachundou SoymilkParticipants will consume two bottles of Dachundou No Sugar Added Soymilk daily (375 mL each; total 750 mL per day) for 8 consecutive weeks. The product is packaged in 375 mL cartons and made from non-GMO soybeans, containing approximately 4.2 g of soy protein per 100 mL. The soymilk is unsweetened and stored at 0-7°C. | Dietary supplement | Soymilk Intervention |
Primary outcome
Change in total cholesterol (TC)
Time frame: Baseline (week 0) to week 8
Serum total cholesterol concentration will be measured using an automated biochemical analyzer to evaluate the lipid-lowering efficacy of Dachundou No Sugar Added Soymilk.
12 secondary outcomes
Change in LDL cholesterol (LDL-C)
Time frame: Baseline to week 8
Change in HDL cholesterol (HDL-C)
Time frame: Baseline to week 8
Change in triglycerides (TG)
Time frame: Baseline to week 8
Change in oxidized LDL (TBARS assay)
Time frame: Baseline to week 8
Change in body weight (kg)
Time frame: Baseline, week 4, week 8, week 10
Liver function markers (AST, ALT, γ-GT)
Time frame: Baseline and week 8
Kidney function markers (BUN, creatinine, uric acid)
Time frame: Baseline and week 8
Change in dietary intake (kcal/day)
Time frame: Baseline, week 4, week 8, week 10
Change in body mass index (BMI, kg/m²)
Time frame: Baseline, week 4, week 8, week 10
Change in waist circumference (cm)
Time frame: Baseline, week 4, week 8, week 10
Change in blood pressure (mmHg)
Time frame: Baseline, week 4, week 8, week 10
Change in physical activity level (IPAQ-SF score, MET-min/week)
Time frame: Baseline, week 4, week 8, week 10
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 13 Apr 2026.
- Results publication: PubMed 28338639Ramdath DD, Padhi EM, Sarfaraz S, Renwick S, Duncan AM. Beyond the Cholesterol-Lowering Effect of Soy Protein: A Review of the Effects of Dietary Soy and Its Constituents on Risk Factors for Cardiovascular Disease. Nutrients. 2017 Mar 24;9(4):324. doi: 10.3390/nu9040324.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the trial involves sensitive health-related data collected from human participants. Only aggregated and de-identified summary results will be published in scientific journals and conference presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dachundou No Sugar Added Soymilk in people with Dyslipidemias and Hypercholesterolemia, run by National Taiwan Sport University at 1 site in Taiwan.
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 13 Apr 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 Taiwan. 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 (TC) (time frame: Baseline (week 0) to week 8). 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 NCT07175766, 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 13 Apr 2026.