NCT04159259

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2019-02-13
• Primary completion: 2019-08-30
• Completion: 2020-06-01
• First posted: 2019-11-12
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States