Probiotics to Improve Women's Health
December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
The purpose of the study is explore the effect of probiotics on plasma lipopolysaccharides (LPS) concentrations, as well as insulin and glucose levels, in obese women prior to and after dietary challenges (high carbohydrate meal, high fat meal).
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Nutrition Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- BMI=30-40 kg/m2
- Healthy, age 18 or older
- Not consuming yogurt or cultured milk regularly (</= 1x/wk) or any probiotic supplement
Exclusion Criteria:
- Medical conditions or medications that may affect metabolism as determined by the PI.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: No groups
|
Probiotics once a day for three weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma LPS concentrations
Time Frame: five weeks
|
five weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Glucose concentrations
Time Frame: five weeks
|
five weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aline Andres, PhD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2012
Primary Completion (Actual)
May 20, 2019
Study Completion (Actual)
May 20, 2019
Study Registration Dates
First Submitted
January 28, 2013
First Submitted That Met QC Criteria
February 26, 2013
First Posted (Estimated)
February 28, 2013
Study Record Updates
Last Update Posted (Estimated)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.