Back to results

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

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

plant sterol and soluble fiber-enriched soymilk

soymilk

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion criteria:

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
Start taking any medication that may affect serum lipid profiles or immunosuppressive agents during in the study
Receiving dietary supplement with plant sterols/ stanols and/ or fiber.

Sites / Locations

Clinical trial Unit, Faculty of Medicine, Chiang Mai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

soymilk

sterol/fiber-enriched soymilk

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

to evaluate the change of total cholesterol, triglyceride, HDL-C, FBS between SFSM and SM group and between baseline and after 8 weeks of consumption

scale of study product satisfaction

score the product satisfaction after 2 weeks and 8 weeks consumption

evaluate any adverse events

gastrointestinal side effects of the product consumption

Full Information

NCT ID

NCT02459314

First Posted

May 15, 2015

Last Updated

May 28, 2015

Sponsor

Chiang Mai University

1. Study Identification

Unique Protocol Identification Number

NCT02459314

Brief Title

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

Acronym

sterols

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiang Mai University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

This was a multicenter, prospective, randomized, double-blinded, controlled-trial study in hypercholesterolemic volunteers (serum LDL-C > 130 mg/dL). After initial assessment at the screening period, eligible subjects were randomized to receive either plant sterol and soluble fiber-enriched soymilk (SFSM) or plain soymilk (SM) 360 mL/day (2 packages a day) for 8 weeks. The participants might take the study product as snack, the first one in the morning and the second one in the afternoon. It was possible to take it before or after meal, however taken before meal was highly suggested. A physical examination (including vital signs, height, weight, body mass index, waist circumference, and systemic evaluation) was performed at each visit, every 2 weeks. Concurrent medications usage were record at each visit during the study as well. Three-day per week of food intake and weekly exercises were recorded and evaluated at every visit. It was recommended every participant to follow dietary control and lifestyle modification to improve hypercholesterolemia during the entire study. Details of overall product satisfaction were evaluated by the participants after 2 and 8 weeks of study products consumption (at visit 2 and 5). To evaluate compliance, the participants were asked to collect and return the empty packages to the investigator every 2 weeks at visit 2, 3, 4, and 5. More than 90% of study product consumption would be considered as eligible on-going subjects. Venous blood samples were collected from the eligible subjects during pre-treatment (screening period; day -7), every 2 week after treatment (visit 2, 3, 4, 5; at the end of week 2, 4, 6 and 8) to test for lipid profiles and fasting blood sugar (FBS). Adverse events, if any, were recorded immediately after study enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

soymilk

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

sterol/fiber-enriched soymilk

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

plant sterol and soluble fiber-enriched soymilk

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

soymilk

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Description

to evaluate the change of total cholesterol, triglyceride, HDL-C, FBS between SFSM and SM group and between baseline and after 8 weeks of consumption

Time Frame

8 weeks

Title

scale of study product satisfaction

Description

score the product satisfaction after 2 weeks and 8 weeks consumption

Time Frame

8 weeks

Title

evaluate any adverse events

Description

gastrointestinal side effects of the product consumption

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

fasting plasma glucose (FPG)

Description

compare the FPG between SFSM and soymilk consumption in 8 weeks and compare between baseline and after 8 weeks of consumption

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion criteria: 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 Start taking any medication that may affect serum lipid profiles or immunosuppressive agents during in the study Receiving dietary supplement with plant sterols/ stanols and/ or fiber.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Supawan Buranapin, MD

Organizational Affiliation

Faculty of Medicine, Chiang Mai University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical trial Unit, Faculty of Medicine, Chiang Mai University

City

Muang

State/Province

ChiangMai

ZIP/Postal Code

50200

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs