Healthy
Conditions
Brief summary
This study is to evaluate the safety and efficacy of consumption of: L.Ruteri containing yogurt, L.Fermentum containing yogurt VERSUS placebo on plasma lipids, as well as gastrointestinal microflora distribution in hyperlipidemic individuals.
Interventions
DIETARY_SUPPLEMENTL. Amylovorus
L. Amylovorus
DIETARY_SUPPLEMENTL. Fermentum
L. Fermentum
Sponsors
Micropharma Limited
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females * aged 18-60 yr * plasma LDL-C 130-260 mg/dl * TG levels below 400 mg/dl * body mass index (BMI) rangewill be 22 to 32 kg/m2 * 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 mo, - 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, lactose intolerance 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 * chronic user of probiotics, fiber laxative (greater than 2 doses/wk), or stimulant laxatives or has a history of eating disorders, exercise greater than 15 miles/wk or 4,000 kcal/wk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cholesterol Metabolism | 1 month |
Outcome results
None listed