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

NCT04159259 | Completed

• 1 other identifier: 201812063
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Diet intervention

EXPERIMENTAL

All participants will stay weight stable while undergoing 3 phases of a dietary intervention

Other: Low fiber diet; Other: Pea Fiber Bar

Interventions

Low fiber diet OTHER

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)

Diet intervention

Pea Fiber Bar OTHER

Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35

Diet intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 25.0-35.0 kg/m²
• Presence of B. vulgatus and B. thetaiotaomicron each at greater than 0.01% relative abundance

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Tara Wilmot

St Louis, Missouri, 63146, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: November 12, 2019
• Study Start: February 13, 2019
• Primary Completion: August 30, 2019
• Study Completion: June 1, 2020
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

US (1)