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

NCT ID: NCT04159259

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Microbial Colonization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet intervention

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

Group Type EXPERIMENTAL

Low fiber diet

Intervention Type 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

Intervention Type OTHER

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

Low fiber diet

Intervention Type OTHER

Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.

Interventions

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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)

Intervention Type OTHER

Pea Fiber Bar

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

Intervention Type OTHER

Low fiber diet

Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Tara Wilmot

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201812063

Identifier Type: -

Identifier Source: org_study_id