An interventional study of Dachundou No Sugar Added Soymilk in Dyslipidemias, Hypercholesterolemia and Cardiovascular Diseases, sponsored by National Taiwan Sport University. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by National Taiwan Sport University · Not applicable, Interventional, and Treatment
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.
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.
1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.
This study's enrollment of 25 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →National Taiwan Sport University is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Dietary Supplement: Dachundou No Sugar Added 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.
Also known as: Unsweetened Dachundou Soymilk
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.
Time frame: Baseline (week 0) to week 8
Change in LDL cholesterol (LDL-C)
LDL-C concentration measured by automated biochemical analyzer.
Time frame: Baseline to week 8
Change in HDL cholesterol (HDL-C)
HDL-C concentration measured by automated biochemical analyzer.
Time frame: Baseline to week 8
Change in triglycerides (TG)
Serum triglyceride concentration measured by automated biochemical analyzer.
Time frame: Baseline to week 8
Change in oxidized LDL (TBARS assay)
Oxidative stress marker (TBARS values in LDL fraction).
Time frame: 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.
Time frame: Baseline, week 4, week 8, week 10
Liver function markers (AST, ALT, γ-GT)
Serum liver enzymes assessed for safety.
Time frame: Baseline and week 8
Kidney function markers (BUN, creatinine, uric acid)
Serum renal parameters assessed for safety.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 4, week 8, week 10
Plan to share: 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.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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