Probiotics to Improve Women's Health

• Sponsor: Arkansas Children's Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01800760
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 85.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Probiotics to Improve Women's Health
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: May 20, 2019
• Actual Study Completion Date: May 20, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Plasma LPS concentrations [five weeks]

Secondary Outcome Measures

1. Glucose concentrations [five weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arkansas Children's Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT01800760
• Other Study ID Numbers: 136010
• First Posted: Feb 28, 2013
• Last Update Posted: Jul 12, 2019
• Last Verified: Jul 1, 2019

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

Study Results

No Results Posted as of Jul 12, 2019