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

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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

Tracking Information
First Submitted Date  ICMJE June 12, 2013
First Posted Date  ICMJE June 17, 2013
Last Update Posted Date July 10, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01879098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 14, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • 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
  • 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
  • Dietary Supplement: Placebo
    Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
    Intervention: Dietary Supplement: Placebo
  • 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).
    Intervention: Dietary Supplement: Probiotic: Bacillus subtilis
  • 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).
    Intervention: Dietary Supplement: Lactobacillus plantarum
  • 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).
    Intervention: Dietary Supplement: Bifidobacterium animalis
Publications * Culpepper T, Rowe CC, Rusch CT, Burns AM, Federico AP, Girard SA, Tompkins TA, Nieves C Jr, Dennis-Wall JC, Christman MC, Langkamp-Henken B. Three probiotic strains exert different effects on plasma bile acid profiles in healthy obese adults: randomised, double-blind placebo-controlled crossover study. Benef Microbes. 2019 May 28;10(5):497-509. doi: 10.3920/BM2018.0151. Epub 2019 May 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
155
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2013)
200
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01879098
Other Study ID Numbers  ICMJE IRB# 70-2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Lallemand Health Solutions
Investigators  ICMJE
Principal Investigator: Bobbi Langkamp-Henken, PhD, RD University of Florida
PRS Account University of Florida
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP