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Efficacy of Two Yogurt Formulations in Healthy Humans (MPH)

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ClinicalTrials.gov Identifier: NCT01409668
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
Micropharma Limited
Information provided by:
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: L. Amylovorus Dietary Supplement: L. Fermentum Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Two Yogurt Formulations as Health Promoting Agents in Healthy Humans
Study Start Date : September 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: L. Amylovorus Dietary Supplement: L. Amylovorus
L. Amylovorus
Experimental: L. Fermentum Dietary Supplement: L. Fermentum
L. Fermentum



Primary Outcome Measures :
  1. Cholesterol Metabolism [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Responsible Party: Dr. Peter Jones, Director of RCFFN, RCFFN, University of Manitoba
ClinicalTrials.gov Identifier: NCT01409668     History of Changes
Other Study ID Numbers: B2007:070
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: May 2007