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

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

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160921002
Enrollment
Unknown
Registered
2016-09-21
Start date
2013-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

LDL cholesterol LDL cholesterol&#44

Interventions

180 ml of soy milk which contains 4.5 gm of fat&#44
5 gm of protein&#44
and 12 gm of carbohydrate fortified with 1 gm phytosterol and 5 gm inulin,180 ml of soy milk which contains 4.5 gm of fat&#44
and 12 gm of carbohydrate without phytosterol or inulin
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
soy milk fortified with phytosterol and inulin,unfortified soy milk

Sponsors

none
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
LDL cholesterol 2, 4, 8, 12 weeks lipid profile

Secondary

MeasureTime frame
total cholesterol, HDL cholesterol, triglyceride 2, 4, 8, 12 weeks lipid profile

Countries

Thailand

Contacts

Public ContactMayuree Homsanit

Mahidol University

mayuree.hom@mahidol.ac.th66816416149

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026