MPH: Efficacy of Two Yogurt Formulations in Healthy Humans

• Sponsor: University of Manitoba (Other)
• Overall Status: Completed
• CT.gov ID: NCT01409668
• Collaborator: Micropharma Limited (Industry)
• Enrollment: 30
• Arms: 2
• Duration (Months): 33

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Sep 1, 2007
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: L. Amylovorus	Dietary Supplement: L. Amylovorus; L. Amylovorus
Experimental: L. Fermentum	Dietary Supplement: L. Fermentum; L. Fermentum

Outcome Measures

Primary Outcome Measures

1. Cholesterol Metabolism [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Manitoba
• Micropharma Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01409668
• Other Study ID Numbers: B2007:070
• First Posted: Aug 4, 2011
• Last Update Posted: Aug 4, 2011
• Last Verified: May 1, 2007

Study Results

No Results Posted as of Aug 4, 2011