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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Probiotic: Bacillus subtilis
Lactobacillus plantarum
Bifidobacterium animalis
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring probiotics, inflammation, bile, hunger, satiety

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Probiotic: Bacillus subtilis

Probiotic: Lactobacillus plantarum

Probiotic: Bifidobacterium animalis

Arm Description

Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).

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).

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).

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).

Outcomes

Primary Outcome Measures

Difference in deconjugated bile acids in the blood
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
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.

Full Information

First Posted
June 12, 2013
Last Updated
July 9, 2014
Sponsor
University of Florida
Collaborators
Lallemand Health Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01879098
Brief Title
The Effect of 3 Probiotic Strains on Bile Acids, Satiety, and Inflammation
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Lallemand Health Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
probiotics, inflammation, bile, hunger, satiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Arm Title
Probiotic: Bacillus subtilis
Arm Type
Experimental
Arm Description
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).
Arm Title
Probiotic: Lactobacillus plantarum
Arm Type
Experimental
Arm Description
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).
Arm Title
Probiotic: Bifidobacterium animalis
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Probiotic: Bacillus subtilis
Other Intervention Name(s)
Bacillus subtilis R0179
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum
Other Intervention Name(s)
Lactobacillus plantarum HA-119
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium animalis
Other Intervention Name(s)
Bifidobacterium animalis subsp. lactis LAFTI B94
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Primary Outcome Measure Information:
Title
Difference in deconjugated bile acids in the blood
Description
Levels of deconjugated bile acids in the stool and in the blood will be compared between treatment periods for each subject/group.
Time Frame
Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
Secondary Outcome Measure Information:
Title
Satiety and glucose metabolism
Description
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.
Time Frame
Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
Other Pre-specified Outcome Measures:
Title
Inflammatory status
Description
Levels of inflammatory markers in the blood will be compared between treatment periods for each subject/group.
Time Frame
Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bobbi Langkamp-Henken, PhD, RD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31090458
Citation
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.
Results Reference
derived

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

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