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The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation

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.
 
ClinicalTrials.gov Identifier: NCT01879098
Recruitment Status : Completed
First Posted : June 17, 2013
Last Update Posted : July 10, 2014
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida

Study Description
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Brief Summary:
The purpose of this research study is to determine whether a probiotic can change the way bile is used by the body. The investigators will also look at the effect of the probiotic on your intestinal health.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Probiotic: Bacillus subtilis Dietary Supplement: Lactobacillus plantarum Dietary Supplement: Bifidobacterium animalis Dietary Supplement: Placebo Phase 1

Detailed Description:

This is a randomized, double-blind, placebo controlled crossover study. After obtaining informed consent, healthy, middle-aged adults with a larger waist circumference (n=30/probiotic cross with n=90 total/study) will be randomized to one of four groups: Bacillus subtilis, Lactobacillus plantarum, Bifidobacterium animalis subsp. lactis, or placebo. Participants will consume 1 capsule per day of probiotic or placebo for 6 weeks. After a 4-week washout period, participants will be crossed to the other treatment (i.e., probiotic to placebo or placebo to probiotic).

Participants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected at the baseline and final time points (±3 days) of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms and physical activity questionnaires will be completed weekly during each intervention period and also the weeks before and after each intervention period.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation in Healthy, Middle-aged Adults: a Randomized, Double-blinded, Placebo-controlled Study
Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
 Dietary Supplement: Placebo
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Experimental: Probiotic: Bacillus subtilis
Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
 Dietary Supplement: Probiotic: Bacillus subtilis
Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Other Name: Bacillus subtilis R0179
Experimental: Probiotic: Lactobacillus plantarum
Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
 Dietary Supplement: Lactobacillus plantarum
Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Other Name: Lactobacillus plantarum HA-119
Experimental: Probiotic: Bifidobacterium animalis
Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
 Dietary Supplement: Bifidobacterium animalis
Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Other Name: Bifidobacterium animalis subsp. lactis LAFTI B94


Outcome Measures
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Primary Outcome Measures :
  1. Difference in deconjugated bile acids in the blood [ Time Frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 ]
    Levels of deconjugated bile acids in the stool and in the blood will be compared between treatment periods for each subject/group.


Secondary Outcome Measures :
  1. Satiety and glucose metabolism [ Time Frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 ]
    Levels of hormones associated with hunger, satiety and glucose metabolism in the blood will be compared between treatment periods for each subject/group. Daily questionnaires will also assess hunger/satiety.


Other Outcome Measures:
  1. Inflammatory status [ Time Frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 ]
    Levels of inflammatory markers in the blood will be compared between treatment periods for each subject/group.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

To participate in the study you must:

  • Be 35-65 years of age.
  • Have a waist circumference > 102 cm (40 in) for males, and > 88 cm (35 in) for females.
  • Be willing and able to complete the Informed Consent Form in English.
  • Be available for 18 consecutive weeks to participate in this study.
  • Be willing and able to complete daily and weekly questionnaires regarding general wellness, bowel function, gastrointestinal symptoms, physical activity level, and dietary intake.
  • Be willing to provide 4 blood samples and 4 stool samples.
  • Be willing to maintain your regular level of physical activity and your diet for 18-week study.
  • Be able to take the study supplement without the aid of another person.
  • Be willing to discontinue consumption of fermented foods or probiotics (e.g., yogurts with live, active cultures or supplements).
  • Be willing to provide a social security number (SS#) to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.

Exclusion Criteria:

To participate in the study you must NOT:

  • Fail to meet any of the criteria I mentioned above.
  • Consume >20 g fiber daily, according to the Block Fiber Screener.
  • Be taking any statins or cholesterol-lowering prescription drugs now, or within the last 6 months.
  • Be currently taking any constipation or diarrhea on a regular basis.
  • Be currently taking any systemic corticosteroids, androgens (such as testosterone), or large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
  • Have used plant sterols, n-3 fatty acids, fish oil, soy protein, soluble oat fiber, psyllium seed husk or other cholesterol-lowering supplements within the last 3 months.
  • Have received antibiotic therapy or a colonoscopy in the past two months.
  • Currently be treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, colostomy, but not including Gastroesophageal Reflux Disease (GERD); or have a central venous catheter.
  • Taking medications for type 1 or type 2 diabetes.
  • Be physically active or very physically active. Active = typical daily living activities PLUS at least 60 minutes of daily moderate activity. Very active = typical daily living activities PLUS at least 60 minutes of daily moderate activity, PLUS an additional 60 minutes of vigorous activity OR 120 minutes of moderate activity.
Contacts and Locations
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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): NCT01879098


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Health Solutions
Investigators
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Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01879098    
Other Study ID Numbers: IRB# 70-2013
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by University of Florida:
probiotics
inflammation
bile
hunger
satiety
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes