Comparison of the Efficacy of Plant Sterol-Enriched Soymilk Versus Plain Soymilk in Volunteers With High LDL-Cholesterol

NCT02459314 | Completed DMC

• 1 other identifier: Dutchmill 002
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

This was a multicenter, prospective, randomized, double-blinded, controlled-trial study in hypercholesterolemic volunteers (serum LDL-C \> 130 mg/dL). Eligible subjects were randomized to receive either plant sterol and soluble fiber-enriched soymilk or plain soymilk 360 mL/day (2 packages a day) for 8 weeks. Venous blood samples were collected from the eligible subjects during pre-treatment (screening period; day -7), every 2 week after treatment (at the end of week 2, 4, 6 and 8) to test for lipid profiles and fasting blood sugar (FBS).

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• the change of serum LDL-C levels between 8-week ingestion of plant sterol and soluble fiber-enriched soymilk (SFSM) versus plain soymilk (SM).

  compare the change of LDL-C between those who took SFSM and those who took SM and between baseline and after 8 weeks of consumption

  8 weeks

Secondary Outcomes (3)

• changes in other lipid profiles (total cholesterol, HDL-C and triglyceride)

  8 weeks

• scale of study product satisfaction

  8 weeks

• evaluate any adverse events

  8 weeks

Other Outcomes (1)

• fasting plasma glucose (FPG)

  8 weeks

Study Arms (2)

soymilk

PLACEBO COMPARATOR

Soymilk (SM) contained 5 gm soy protein and 6.5 gm sugar per 180 mL package.

Dietary Supplement: soymilk

sterol/fiber-enriched soymilk

ACTIVE COMPARATOR

PLant sterol and soluble fiber-enriched soymilk (SFSM) contained 1 gm free plant sterol, 5 gm inulin (soluble fiber), 5 gm soy protein and 6.5 gm sugar per 180 mL package

Dietary Supplement: plant sterol and soluble fiber-enriched soymilk

Interventions

plant sterol and soluble fiber-enriched soymilk DIETARY_SUPPLEMENT

Sterols compete with LDL-C for absorption in GI tract. A meta-analysis of 41 trials indicated that an intake of 2 g sterols/stanols reduces the LDL-C level by 10%. Additive effects occur when sterols are combined with statins; the combination being more efficacious than a 2 times up-dosing of statins alone. Soluble dietary fibers also have significant cholesterol lowering effects. In a meta-analysis, Brown et al estimate that a daily soluble fiber intake ranging from 9-30 g/d, were associated with 10.6% reduction in LDL-C levels.

sterol/fiber-enriched soymilk

soymilk DIETARY_SUPPLEMENT

Soy protein is another LDL-C and total cholesterol lowering food. A meta-analysis by Reynolds K et al. discovered that volunteers receiving 20 to more than 61 g of soy protein had reductions in total cholesterol by 5.26 mg/dL (95% CI -7.14 to -3.38), and LDL-C by 4.25 mg/dL (95% CI -6.00 to -2.50), with an increase of HDL-C by 0.77 mg/dL (95% CI 0.20 to 1.34). Reductions in LDL cholesterol were larger in hypercholesterolemic than in normocholesterolemic subjects.

soymilk

Eligibility Criteria

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

You may qualify if:

• Healthy male or female, age \> 18 years
• If female, subject is either post-menopausal or surgically sterilized, or has a negative urine pregnancy test within 7 days prior to enrollment and will use adequate contraception during the study
• Has LDL-C \> 130 mg/dL
• If subject has been treated with cholesterol-lowering agents prior to admission, he/she must have taken medication regularly at a stable dose for at least 8 weeks
• Provided written informed consent prior to admission to the study.

You may not qualify if:

• Has history of organ transplantation
• Hypersensitivity to soy bean or has specific allergy to the ingredients of soymilk
• Has taken any medication that affects serum cholesterol level, such as oral contraceptive pills, high dose diuretics or beta-blockers, antiretroviral protease inhibitors, tegretol, and anabolic steroids, unless these drugs have been consumed at the same dosage for \> 8 weeks prior to admission of the study
• Has serum triglyceride ≥ 400 mg/dL
• Immunocompromised status, including a debilitated state or malignancy
• Has consumed any immunosuppressive agents such as cyclosporine, tacrolimus, azathioprine, and chemotherapeutic agents
• Active liver, renal or thyroid diseases
• Recent myocardial infarction or stroke within 3 months prior to admission
• Has recently been admitted in the hospital due to any illness within 2 months prior to admission
• Frequent alcoholic consumption \> 2 a week; with beer \> 360 mL, alcohol \> 45 mL, wine \> 150 mL for female, or beer \> 720 mL, whisky \> 90 mL, wine \> 300 mL for male each time
• HasGI symptoms such as nausea, vomiting, loss of appetite, premature satiety, diarrhea, or chronic constipation
• Consume study product less than 90% during in treatment period
• Pregnancy or breast feeding woman
• Has previously been admitted to this study
• Lack of ability or willingness to give informed consent

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Clinical trial Unit, Faculty of Medicine, Chiang Mai University

Muang, ChiangMai, 50200, Thailand

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Officials

• Supawan Buranapin, MD

  Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: June 2, 2015
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

TH (1)