Efficacy of Two Yogurt Formulations in Healthy Humans (MPH)
This study has been completed.
Sponsor:
University of Manitoba
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
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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
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 May 21, 2013