Dachundou No Sugar Added Soymilk for Lipid Modulation

NCT07175766 | Completed

• 2 other identifiers: IRB-25-058-A22025-Dachundou-IRB-25-058-A2
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dyslipidemias; Hypercholesterolemia; Cardiovascular Diseases

Keywords

Soy milk; Dachundou; No sugar added soymilk; Cholesterol; Total cholesterol; LDL cholesterol; HDL cholesterol; Lipid metabolism; Functional food; Cardiovascular health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (week 0) to week 8

Secondary Outcomes (12)

• Change in LDL cholesterol (LDL-C)

  Baseline to week 8

• Change in HDL cholesterol (HDL-C)

  Baseline to week 8

• Change in triglycerides (TG)

  Baseline to week 8

• Change in oxidized LDL (TBARS assay)

  Baseline to week 8

• Change in body weight (kg)

  Baseline, week 4, week 8, week 10

Study Arms (1)

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).

Dietary Supplement: Dachundou No Sugar Added Soymilk

Interventions

Dachundou No Sugar Added Soymilk DIETARY_SUPPLEMENT

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

Soymilk Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan Sport University: lead

Study Sites (1)

National Taiwan Sport University

Taoyuan District, 333325, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 28338639 RESULT

MeSH Terms

Conditions

Dyslipidemias; Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperlipidemias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study is conducted as an open-label, single-group dietary intervention. No masking is applied to participants, investigators, care providers, or outcome assessors.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Model Details: 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).

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 16, 2025
• Study Start: September 15, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)