Efficacy of Two Yogurt Formulations in Healthy Humans (MPH)

University of Manitoba

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Dietary Supplement: L. Amylovorus

Dietary Supplement: L. Fermentum

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01409668

B2007:070

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.