NCT01800760

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2019

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

7.1 years

First QC Date

January 28, 2013

Last Update Submit

December 18, 2023

Conditions

Healthy

Keywords

healthyobesewomen

Outcome Measures

Primary Outcomes (1)

  • Plasma LPS concentrations

    five weeks

Secondary Outcomes (1)

  • Glucose concentrations

    five weeks

Study Arms (1)

No groups

EXPERIMENTAL
Dietary Supplement: Probiotics

Interventions

ProbioticsDIETARY_SUPPLEMENT

Probiotics once a day for three weeks.

No groups

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI=30-40 kg/m2
  • Healthy, age 18 or older
  • Not consuming yogurt or cultured milk regularly (\</= 1x/wk) or any probiotic supplement

You may not qualify if:

  • Medical conditions or medications that may affect metabolism as determined by the PI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Aline Andres, PhD

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 28, 2013

Study Start

April 1, 2012

Primary Completion

May 20, 2019

Study Completion

May 20, 2019

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

US(1)