Effect of Phytosterol and Inulin Fortified Soy Milk on Serum Lipid in Thai-Hypercholesterolemic Volunteers: A Double-Blinded Randomized-Controlled Trial

Phase 2

Completed

• Conditions: DL cholesterol; LDL cholesterol, LDL reduction, phytosterol, inulin

• Registration Number: TCTR20160921002
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-11-29
• Study Start: 2016-09-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1) more than 18 years of age
2) had LDL-c of 130-190 mg/dL without lipid lowering medication
3) consent to join the study

Exclusion Criteria

1) LDL-c of >190 mg/dL
2) high risk for cardiovascular disease as determined by Framingham risk assessment of >20% in 10 years
3) LDL-c of >160 mg/dL with risk of >10% in 10 years without receiving lipid lowering medication
4) coronary heart disease, symptomatic carotid artery disease, abdominal aortic aneurysm, or peripheral arterial disease
5) type 1 or type 2 diabetes with hemoglobin A1c (HbA1c) of >7.5%
6) secondary dyslipidemia from nephrotic syndrome, hypothyroidism, hepatic disorder, Cushing’s syndrome, or other conditions
7) malabsorption
8) allergy to soy or soy product

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DL cholesterol 2, 4, 8, 12 weeks lipid profile

Secondary Outcome Measures

Name	Time	Method
total cholesterol, HDL cholesterol, triglyceride 2, 4, 8, 12 weeks lipid profile