Efficacy of Two Yogurt Formulations in Healthy Humans

NCT ID: NCT01409668

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L. Amylovorus

Group Type EXPERIMENTAL

L. Amylovorus

Intervention Type DIETARY_SUPPLEMENT

L. Amylovorus

L. Fermentum

Group Type EXPERIMENTAL

L. Fermentum

Intervention Type DIETARY_SUPPLEMENT

L. Fermentum

Interventions

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L. Amylovorus

L. Amylovorus

Intervention Type DIETARY_SUPPLEMENT

L. Fermentum

L. Fermentum

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Micropharma Limited

INDUSTRY

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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RCFFN, University of Manitoba

Other Identifiers

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B2007:070

Identifier Type: -

Identifier Source: org_study_id

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