NCT00923403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

4 months

First QC Date

June 16, 2009

Last Update Submit

June 17, 2009

Conditions

Hypercholesterolemia

Keywords

plant sterolsdietsoymilkcholesterol

Outcome Measures

Primary Outcomes (1)

  • plasma cholesterol

    30 days

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

control dairy milk

Dietary Supplement: control dairy milk

experimental

EXPERIMENTAL

plant sterol enriched soymilk

Dietary Supplement: plant sterol enriched soymilk

Interventions

plant sterol enriched soymilkDIETARY_SUPPLEMENT

plant sterol enriched soymilk

experimental
control dairy milkDIETARY_SUPPLEMENT

control dairy milk

Placebo Comparator

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 6C5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19843338DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Peter JH Jones, PHD

    Richardson Centre for Functional Foods and Nutraceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 18, 2009

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

January 1, 2009

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

CA(1)