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Efficacy of Two Yogurt Formulations in Healthy Humans (MPH)

This study has been completed.
Sponsor:
Collaborator:
Micropharma Limited
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01409668
First received: June 22, 2011
Last updated: August 3, 2011
Last verified: May 2007
  Purpose

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 Intervention Phase
Healthy
Dietary Supplement: L. Amylovorus
Dietary Supplement: L. Fermentum
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Two Yogurt Formulations as Health Promoting Agents in Healthy Humans

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cholesterol Metabolism [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L. Amylovorus Dietary Supplement: L. Amylovorus
L. Amylovorus
Experimental: L. Fermentum Dietary Supplement: L. Fermentum
L. Fermentum

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: June 22, 2011
Last Updated: August 3, 2011
Health Authority: Canada: Ethic Review Committee

ClinicalTrials.gov processed this record on November 27, 2014