Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB) (FIB)
Primary Purpose
Microbial Colonization
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low fiber diet
Pea Fiber Bar
Low fiber diet
Sponsored by
About this trial
This is an interventional treatment trial for Microbial Colonization
Eligibility Criteria
Inclusion Criteria:
- BMI 25.0-35.0 kg/m²
- Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance
Exclusion Criteria:
- Previous bariatric surgery
- Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or cardiovascular disease)
- Cancer or cancer that has been in remission for less than 5 years
- Major psychiatric illness
- Inflammatory gastrointestinal disease
- Pregnant or lactating women
- Use of medications that are known to affect the study outcome measures
- Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
- Bowel movements less than 3 times per week
- Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
- Persons that are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.
Sites / Locations
- Tara Wilmot
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diet intervention
Arm Description
All participants will stay weight stable while undergoing 3 phases of a dietary intervention
Outcomes
Primary Outcome Measures
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
Blood will be drawn for the complete metabolic panel and lipid panel
Changes to the gut microbiota as assessed by established culture independent methods, as well as LC-QTOF Mass-Spectometry (MS) and LC-QQQ MS and GC-MS
Frequent stool samples will be collected throughout the entire study
Changes in urine proteomes and metabolomes as assessed by liquid chromatography
First morning urine samples will be collected periodically throughout the study
Changes in plasma proteomes and metabolomes as assessed by liquid chromatography
fasting blood draws will be collected periodically throughout the study
Change in hemoglobin A1c (HbA1c) in response to the dietary intervention
Blood will be drawn for the HbA1c
Secondary Outcome Measures
Full Information
NCT ID
NCT04159259
First Posted
March 21, 2019
Last Updated
July 15, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04159259
Brief Title
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)
Acronym
FIB
Official Title
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
All subjects will complete a 49-day, multi-phase feeding study to evaluate the effect of pea fiber supplementation on gut community structure and features of host biological state (plasma proteome/ metabolome). Subjects will be asked to continue to consume their habitual diet (free diet phase) for 4 days prior to being provided with a diet high in saturated fat (HiSF) and low in fruits and vegetables (LoFV) in the form of packed-out meals and snacks to consume for the following 45 days. Ten days after starting to consume the HiSF-LoFV diet, subjects will supplement their diet with pea fiber for a total of 21 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time. After completing the pea fiber supplementation phase of the study subjects will revert back to consuming the HiSF-LoFV only diet for the final 14 days. Stool, urine and blood will be sampled periodically throughout.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet intervention
Arm Type
Experimental
Arm Description
All participants will stay weight stable while undergoing 3 phases of a dietary intervention
Intervention Type
Other
Intervention Name(s)
Low fiber diet
Intervention Description
Participants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49)
Intervention Type
Other
Intervention Name(s)
Pea Fiber Bar
Intervention Description
Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35
Intervention Type
Other
Intervention Name(s)
Low fiber diet
Intervention Description
Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.
Primary Outcome Measure Information:
Title
Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.
Description
Blood will be drawn for the complete metabolic panel and lipid panel
Time Frame
At screening, day 14, day 35, and day 49
Title
Changes to the gut microbiota as assessed by established culture independent methods, as well as LC-QTOF Mass-Spectometry (MS) and LC-QQQ MS and GC-MS
Description
Frequent stool samples will be collected throughout the entire study
Time Frame
stool samples will be collected from the screening visit through the final day of the 49-day intervention
Title
Changes in urine proteomes and metabolomes as assessed by liquid chromatography
Description
First morning urine samples will be collected periodically throughout the study
Time Frame
Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study
Title
Changes in plasma proteomes and metabolomes as assessed by liquid chromatography
Description
fasting blood draws will be collected periodically throughout the study
Time Frame
Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study
Title
Change in hemoglobin A1c (HbA1c) in response to the dietary intervention
Description
Blood will be drawn for the HbA1c
Time Frame
At screening, day 14, day 35, and day 49
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI 25.0-35.0 kg/m²
Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance
Exclusion Criteria:
Previous bariatric surgery
Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or cardiovascular disease)
Cancer or cancer that has been in remission for less than 5 years
Major psychiatric illness
Inflammatory gastrointestinal disease
Pregnant or lactating women
Use of medications that are known to affect the study outcome measures
Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
Bowel movements less than 3 times per week
Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
Persons that are not able to grant voluntary informed consent
Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Klein, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tara Wilmot
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)
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