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Probiotics to Improve Women's Health

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ClinicalTrials.gov Identifier: NCT01800760
Recruitment Status : Active, not recruiting
First Posted : February 28, 2013
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Probiotics Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Probiotics to Improve Women's Health
Actual Study Start Date : April 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Women's Health
U.S. FDA Resources

Arm Intervention/treatment
Experimental: No groups Dietary Supplement: Probiotics
Probiotics once a day for three weeks.



Primary Outcome Measures :
  1. Plasma LPS concentrations [ Time Frame: five weeks ]

Secondary Outcome Measures :
  1. Glucose concentrations [ Time Frame: five weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800760


Locations
United States, Arkansas
Arkansas Children's Nutrition Center
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Aline Andres, PhD University of Arkansas

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01800760     History of Changes
Other Study ID Numbers: 136010
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by Arkansas Children's Hospital Research Institute:
healthy
obese
women