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PsylliumRx Dietary Fiber Study

NCT03629119 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-01-18

No results posted yet for this study

Summary

The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium powder) and obtaining their parents' support, 2) recruit into a clinical pilot trial with liquid meal challenge test to study the metabolic effects of the dietary fiber preparation. A study modification will be submitted to add additional study arms for feasibility (strength training, coaching).

Conditions

Interventions

DIETARY_SUPPLEMENT

Dietary Fiber Supplement

Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. Participants will be asked to keep a diary assessing bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629119 on ClinicalTrials.gov