Probiotics to Improve Women's Health

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01800760
First received: January 28, 2013
Last updated: February 11, 2014
Last verified: February 2014
  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). The investigators hypothesize the LPS concentrations will be higher following a high fat meal challenge compared to a high carbohydrate challenge and that glucose and LPS concentrations will be lower after three weeks of probiotic treatment.


Condition Intervention
Healthy
Dietary Supplement: Probiotics

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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:
  • Change in plasma LPS concentrations [ Time Frame: five weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in glucose and LPS concentrations [ Time Frame: five weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01800760     History of Changes
Other Study ID Numbers: 136010
Study First Received: January 28, 2013
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014