Suspended

Effect of a Plant Sterol-Fortified Low-fat Milk Product on Plasma Lipid Levels of Humans in Relation to Different Infant Feeding Practices and Later Life Cholesterol Metabolism

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What is being tested

High cholesterol

+ Plant Sterols

+ Placebo

Other
Who is being recruted

Hyperlipidemias+3

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

From 18 to 50 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Manitoba
Last updated: February 3, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Hypothesis 1: To determine the responsiveness of plasma lipid profile including Total cholesterol and LDL cholesterol concentrations to high and low cholesterol diets in adults who been breast-fed as infants for different durations Hypothesis 2: To determine if differences exist in rates of cholesterol absorption and synthesis in adults, and whether such differences respond to variations in cholesterol intake, between individuals who were breast for different durations. Hypothesis 3: Consumption of a plant sterol formulation in low-fat milk product will favorably alter lipid profiles compared with control in the study population. This is a free-living, randomized, crossover trial. This trial is modeled after previously successful functional food trial at the investigators clinic, consistent with current recommendations to decrease Cardiovascular diseases (CVD) risk and improve circulating lipid profiles. The proposed study will include three treatment phases of 4 weeks each, separated by 4-week washout intervals: Phase 1: Study diets with placebo (240 ml of 2% milk shake; 50 mg cholesterol). Phase 2: Study diets with enriched cholesterol (240ml of 2% milk shake; 600 mg cholesterol). Phase 3: A study diet with plant sterols (240 ml of 2% milk shake;2.0 g/d of plant sterols/240 ml serving; 50 mg cholesterol). During each treatment period participants will consume their supper time meal along with assigned test product. Consumption of the suppertime meals and the test products will be monitored by a clinical coordinator to ensure compliance. Participants will be asked to fill out a 3-day food diary at the beginning and end of each experimental period.

Principal SponsorUniversity of Manitoba
Last updated: February 3, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

55 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperlipidemiasMetabolic DiseasesNutritional and Metabolic DiseasesDyslipidemiasLipid Metabolism DisordersHypercholesterolemia

Criteria

3 inclusion criteria required to participate
Body mass index (BMI) between 20 and 30 kg/m2

Participants must have been breast-fed at least during the first 6 months of their life

Triglycerides (TG) < 3.0 mmol/L

8 exclusion criteria prevent from participating
Exercise greater than walking or running 15 miles/wk or 4,000 kcal/wk

History of chronic use of alcohol ( > 2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin

History of recent (i.e. less than 1 month) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months

Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
600 mg cholesterol/day in 240 ml milk shake

Group II

Experimental
2.0 g of plant sterols/day in 240 ml milk shake containing 50 mg cholesterol

Group III

Placebo
50 mg cholesterol/day in 240 ml of milk shake

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, CanadaOpen Richardson Centre for Functional Foods and Nutraceuticals in Google Maps
SuspendedOne Study Center