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Efficacy of Sterol-Fortified Low Fat Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans - Study II

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

plant sterol enriched soymilk

control dairy milk

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring plant sterols, diet, soymilk, cholesterol

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy males and females, age 19-60 years old, will be screened for determination of fasting circulating LDL-cholesterol and triglyceride (TG) levels.
Subjects accepted into the study will have plasma LDL-C levels between 120 and 200 mg/dl, TG levels below 250 mg/dl, and a body mass index (BMI) between 22 to 32 kg/m2.
Subjects must also demonstrate an ability to understand dietary and exercise procedures and be judged as compliant and motivated by the investigators.
Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.

Exclusion Criteria:

History of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months.
History of chronic use of alcohol (>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin.
Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
Exercise greater than walking or running 15 miles/wk or 4,000 kcal/week.

Sites / Locations

Richardson Centre for Functional Foods and Nutraceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Comparator

experimental

Arm Description

control dairy milk

plant sterol enriched soymilk

Outcomes

Primary Outcome Measures

plasma cholesterol

Secondary Outcome Measures

Full Information

NCT ID

NCT00923403

First Posted

June 16, 2009

Last Updated

June 17, 2009

Sponsor

University of Manitoba

Collaborators

WhiteWave Foods, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00923403

Brief Title

Efficacy of Sterol-Fortified Low Fat Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans - Study II

Official Title

Efficacy of Sterol-Fortified Low Fat Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans - Study II

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Manitoba

Collaborators

WhiteWave Foods, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Hypercholesterolemia is a well-established risk factor for the development of atherosclerosis, a component of cardiovascular disease (CVD). The National Cholesterol Education Program advises the public to consume 2 g/day of plant sterols or stanols in addition to the Therapeutic Lifestyle Change Diet to lower elevated low-density lipoprotein (LDL) cholesterol levels. For foods to carry the FDA health claim label they must contain 0.65 g of phytosterol ester or 1.7 g of phytostanol ester per serving. The study was a controlled diet, cross-over clinical investigation using a Latin square sequence. It consisted of two 29 d phases separated by a four week wash out interval. Subjects were randomized to one of two treatment arms: 1 % dairy milk or low-fat soy beverage providing 1.95 g plant sterols/day.

6. Conditions and Keywords

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

Hypercholesterolemia

Keywords

plant sterols, diet, soymilk, cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Description

control dairy milk

Arm Title

experimental

Arm Type

Experimental

Arm Description

plant sterol enriched soymilk

Intervention Type

Dietary Supplement

Intervention Name(s)

plant sterol enriched soymilk

Intervention Description

plant sterol enriched soymilk

Intervention Type

Dietary Supplement

Intervention Name(s)

control dairy milk

Intervention Description

control dairy milk

Primary Outcome Measure Information:

Title

plasma cholesterol

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males and females, age 19-60 years old, will be screened for determination of fasting circulating LDL-cholesterol and triglyceride (TG) levels. Subjects accepted into the study will have plasma LDL-C levels between 120 and 200 mg/dl, TG levels below 250 mg/dl, and a body mass index (BMI) between 22 to 32 kg/m2. Subjects must also demonstrate an ability to understand dietary and exercise procedures and be judged as compliant and motivated by the investigators. Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study. Exclusion Criteria: History of recent (i.e. less than 3 mo) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months. History of chronic use of alcohol (>2 drinks/d), systemic antibodies, corticosteroids, androgens, or phenytoin. Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months. Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year). Exercise greater than walking or running 15 miles/wk or 4,000 kcal/week.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter JH Jones, PHD

Organizational Affiliation

Richardson Centre for Functional Foods and Nutraceuticals

Official's Role

Principal Investigator

Facility Information:

Facility Name

Richardson Centre for Functional Foods and Nutraceuticals

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3T 6C5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19843338

Citation

Rideout TC, Chan YM, Harding SV, Jones PJ. Low and moderate-fat plant sterol fortified soymilk in modulation of plasma lipids and cholesterol kinetics in subjects with normal to high cholesterol concentrations: report on two randomized crossover studies. Lipids Health Dis. 2009 Oct 20;8:45. doi: 10.1186/1476-511X-8-45.

Results Reference

derived

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Efficacy of Sterol-Fortified Low Fat Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans - Study II

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