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Probiotics to Improve Women's Health

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01800760
First Posted: February 28, 2013
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
  Purpose
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 Intervention
Healthy Dietary Supplement: Probiotics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Probiotics to Improve Women's Health

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

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

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

Enrollment: 20
Actual Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: No groups Dietary Supplement: Probiotics
Probiotics once a day for three weeks.

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01800760     History of Changes
Other Study ID Numbers: 136010
First Submitted: January 28, 2013
First Posted: February 28, 2013
Last Update Posted: June 29, 2017
Last Verified: June 2017

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