A Study on the Lipid-Modulating and Health Benefits of Dachundou No Sugar Added Soymilk in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in total cholesterol (TC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is conducted as an open-label, single-group dietary intervention. No masking is applied to participants, investigators, care providers, or outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Soymilk Intervention
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).
干预措施: Dachundou No Sugar Added Soymilk (Dietary Supplement)
结局指标
主要结局
Change in total cholesterol (TC)
时间窗: 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.
次要结局
- Change in oxidized LDL (TBARS assay)(Baseline to week 8)
- Change in HDL cholesterol (HDL-C)(Baseline to week 8)
- Change in triglycerides (TG)(Baseline to week 8)
- Change in LDL cholesterol (LDL-C)(Baseline to week 8)
- Change in body weight (kg)(Baseline, week 4, week 8, week 10)
- Liver function markers (AST, ALT, γ-GT)(Baseline and week 8)
- Kidney function markers (BUN, creatinine, uric acid)(Baseline and week 8)
- Change in dietary intake (kcal/day)(Baseline, week 4, week 8, week 10)
- Change in body mass index (BMI, kg/m²)(Baseline, week 4, week 8, week 10)
- Change in waist circumference (cm)(Baseline, week 4, week 8, week 10)
- Change in blood pressure (mmHg)(Baseline, week 4, week 8, week 10)
- Change in physical activity level (IPAQ-SF score, MET-min/week)(Baseline, week 4, week 8, week 10)
研究者
Chi-Chang Huang
Distinguished Professor
National Taiwan Sport University