Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome (FIB)

Microbial Colonization Clinical Trial

— FIB  

Official title:

Effect of Pea Fiber Supplementation on the Gut Microbiota and Host Metabolome and Proteome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04159259
• Other study ID #: 201812063
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 1, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Microbial Colonization

Intervention

Other:
• Low fiber diet
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)
• Pea Fiber Bar
Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35
• Low fiber diet
Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.

Locations

Country	Name	City	State
United States	Tara Wilmot	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At screening, day 14, day 35, and day 49
Primary	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	stool samples will be collected from the screening visit through the final day of the 49-day intervention
Primary	Changes in urine proteomes and metabolomes as assessed by liquid chromatography	First morning urine samples will be collected periodically throughout the study	Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study
Primary	Changes in plasma proteomes and metabolomes as assessed by liquid chromatography	fasting blood draws will be collected periodically throughout the study	Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study
Primary	Change in hemoglobin A1c (HbA1c) in response to the dietary intervention	Blood will be drawn for the HbA1c	At screening, day 14, day 35, and day 49