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

This study has been completed.
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01879098
First received: June 12, 2013
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Healthy
Dietary Supplement: Probiotic: Bacillus subtilis
Dietary Supplement: Lactobacillus plantarum
Dietary Supplement: Bifidobacterium animalis
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Satiety and glucose metabolism [ Time Frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 ] [ Designated as safety issue: No ]
    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:
  • Inflammatory status [ Time Frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18 ] [ Designated as safety issue: No ]
    Levels of inflammatory markers in the blood will be compared between treatment periods for each subject/group.


Enrollment: 155
Study Start Date: August 2013
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT01879098

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Lallemand Health Solutions
Investigators
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01879098     History of Changes
Other Study ID Numbers: IRB# 70-2013
Study First Received: June 12, 2013
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
probiotics
inflammation
bile
hunger
satiety

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Bile Acids and Salts
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014