Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-24 @ 3:00 PM
NCT ID:
NCT04159259
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.
Study:
NCT04159259
Study Brief:
Protocol Section:
NCT04159259