Status:

UNKNOWN

Effect of Plant Sterol Enriched Milk on Plasma Lipid Levels of Humans Breast-fed During Infancy

Lead Sponsor:

University of Manitoba

Conditions:

Hypercholesterolemia

CVD

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

The overall goal of this clinical study is to investigate how dietary cholesterol intake influences the plasma Total cholesterol (TC), LDL-Cholesterol levels and cholesterol metabolism between adults ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • Triglycerides (TG) \<3.0 mmol/L
  • 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

Exclusion

  • 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
  • History of chronic use of alcohol (\>2 drinks/d), smoking, systemic antibodies, corticosteroids, androgens, or phenytoin
  • Myocardial infarction, coronary artery bypass, kidney disease, liver disease or other major surgical procedures within the last six months,
  • Sitosterolemic patients
  • Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (i.e. 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/wk
  • Participants who have not been breast-fed at all
  • Pregnant or planning for pregnancy during the next 5 month period

Key Trial Info

Start Date :

March 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2016

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT01825668

Start Date

March 1 2013

End Date

June 1 2016

Last Update

February 3 2016

Active Locations (1)

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1

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada, R3T 2N2