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Completed

NCT Number: NCT04159259

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

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tara Wilmot

St Louis, Missouri, 63146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Pea Fiber Bar

Other

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

Primary outcomes

  1. Change in plasma lipid profile as assessed by the complete metabolic panel and lipid panel.

    Time frame: At screening, day 14, day 35, and day 49

    Blood will be drawn for the complete metabolic panel and lipid panel

  2. 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

    Time frame: stool samples will be collected from the screening visit through the final day of the 49-day intervention

    Frequent stool samples will be collected throughout the entire study

  3. Changes in urine proteomes and metabolomes as assessed by liquid chromatography

    Time frame: Daily or every other day first-morning urine samples will be collected from day 1 to day 49 of the study

    First morning urine samples will be collected periodically throughout the study

  4. Changes in plasma proteomes and metabolomes as assessed by liquid chromatography

    Time frame: Fasted blood draws will be collected on days 1, 14, 21, 28, 35, and 49 of the study

    fasting blood draws will be collected periodically throughout the study

  5. Change in hemoglobin A1c (HbA1c) in response to the dietary intervention

    Time frame: At screening, day 14, day 35, and day 49

    Blood will be drawn for the HbA1c

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Acronym: FIB

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 12, 2019
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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