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Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

phytosterol enhanced soy based beverage

1% milk

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring cholesterol, plant sterols, cholesterol absorption

Eligibility Criteria

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

Inclusion Criteria:

Healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating LDL-cholesterol and TG levels.
Subjects accepted into the study will have plasma LDL-C 130-200 mg/dl, TG levels below 250 mg/dl.
The inclusion for body mass index (BMI) range will be 22 to 32 kg/m2.
Subjects must also demonstrate an ability to understand dietary procedures 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 months) 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/day), 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 15 miles/wk or 4,000 kcal/wk.

Sites / Locations

Richardson Centre for Functional Foods and Nutraceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

dairy milk

phytosterol enhanced soy based beverage

Arm Description

Control phase with 1% milk.

Treatment phase where control-phase diets are provided with phytosterol enhanced soy based beverage.

Outcomes

Primary Outcome Measures

cholesterol

Secondary Outcome Measures

Full Information

NCT ID

NCT00924391

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

NCT00924391

Brief Title

Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans

Official Title

Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans Study 1

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

August 2008 (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

It is becoming increasingly clear that North Americans prefer dietary approaches to enhance health in favour of pharmaceutical approaches. Although the consumption of various phytosterol (PS)-enriched foods have been shown to be effective in lowering plasma cholesterol in a variety of food matrices, the lipid-lowering potential of PS-enriched soymilk has not been investigated. Therefore, the objective of this investigation was to examine the lipid-lowering efficacy of a PS-enriched soymilk beverage in comparison to a 1% dairy milk control. Twenty-three hypercholesterolemic subjects (Total-cholesterol and LDL-cholesterol ≥ 5.0 and 3.5 mmol/L, respectively) consumed 3 tetrapacs per day of a phytosterol-enriched soy beverage providing 1.95g PS/d or a 1% dairy milk control. The study was conducted as a 28 d controlled dietary intervention according to a completely randomized, two-period cross-over design.

6. Conditions and Keywords

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

Coronary Heart Disease

Keywords

cholesterol, plant sterols, cholesterol absorption

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dairy milk

Arm Type

Active Comparator

Arm Description

Control phase with 1% milk.

Arm Title

phytosterol enhanced soy based beverage

Arm Type

Experimental

Arm Description

Treatment phase where control-phase diets are provided with phytosterol enhanced soy based beverage.

Intervention Type

Dietary Supplement

Intervention Name(s)

phytosterol enhanced soy based beverage

Intervention Type

Dietary Supplement

Intervention Name(s)

1% milk

Primary Outcome Measure Information:

Title

cholesterol

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating LDL-cholesterol and TG levels. Subjects accepted into the study will have plasma LDL-C 130-200 mg/dl, TG levels below 250 mg/dl. The inclusion for body mass index (BMI) range will be 22 to 32 kg/m2. Subjects must also demonstrate an ability to understand dietary procedures 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 months) 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/day), 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 15 miles/wk or 4,000 kcal/wk.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter JH Jones, B.ScM.ScPh.D

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 2N2

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 Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans

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