NCT01409668

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
Last Updated

August 4, 2011

Status Verified

May 1, 2007

Enrollment Period

2.8 years

First QC Date

June 22, 2011

Last Update Submit

August 3, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Cholesterol Metabolism

    1 month

Study Arms (2)

L. Amylovorus

EXPERIMENTAL
Dietary Supplement: L. Amylovorus

L. Fermentum

EXPERIMENTAL
Dietary Supplement: L. Fermentum

Interventions

L. AmylovorusDIETARY_SUPPLEMENT

L. Amylovorus

L. Amylovorus
L. FermentumDIETARY_SUPPLEMENT

L. Fermentum

L. Fermentum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2011

First Posted

August 4, 2011

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 4, 2011

Record last verified: 2007-05