Skip to main content
OpenTrials
Completed

NCT Number: NCT01409668

Efficacy of Two Yogurt Formulations in Healthy Humans

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

L. Amylovorus

Dietary Supplement

L. Amylovorus

L. Fermentum

Dietary Supplement

L. Fermentum

Primary outcomes

  1. Cholesterol Metabolism

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Micropharma Limited

Registry information

Official study title

Efficacy of Two Yogurt Formulations as Health Promoting Agents in Healthy Humans

Acronym: MPH

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 4, 2011
Registry last updated
Aug 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.