Pea Fiber for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Florida, Food Science and Human Nutrition Dept, Gainesville, FL
Healthy Subjects (HS)
Pea Fiber - DietarySupplement
Eligibility
< 18
All Sexes
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Study Summary

This study is evaluating whether a fiber supplement may help improve bowel movements and other symptoms for individuals with irritable bowel syndrome.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

This trial is evaluating whether Pea Fiber will improve 1 primary outcome and 2 secondary outcomes in patients with Healthy Subjects (HS). Measurement will happen over the course of Change from baseline at weeks 4, 6 and 8.

Week 4
Microbiota profile changes: percent change at phylum and genus levels; changes in operational taxonomic units (OTUs)
Number of bowel movements per day averaged by week
Stool consistency rating by Modified Bristol Stool Form Scale for Children

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

2 Treatment Groups

Pea Fiber
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 50 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pea Fiber is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Pea Fiber
DietarySupplement
Snacks fortified with 10 g of pea hull fiber will be administered for two weeks, followed by a two-week washout, and a two-week period with control snacks.
Control
DietarySupplement
Control snacks will provided for 2 weeks, followed by a two-week washout, and snacks with 10 g/d of pea fiber for 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pea Fiber
2016
N/A
~40

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline at weeks 4, 6 and 8
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change from baseline at weeks 4, 6 and 8 for reporting.

Closest Location

University of Florida, Food Science and Human Nutrition Dept - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Are willing to have height and weight measured and provide demographic information (e.g. age, race, sex).
Children age between 8-15 years old.
Are occasionally constipated.
Are willing to consume pea hull fiber and control snacks daily each for a 2-week period
Are willing to complete a daily questionnaire throughout the entire 8-weeks study.
Are willing to complete the appetite questionnaire two times per week.
Are willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) bi-weekly.
Are willing to be interviewed for Automated Self-Administered 24-Hour-Kids-2014 (ASA24-Kids-2014) one time per 2-week period throughout the study.
Are willing and be able to provide a valid social security for study payment purposes.
Have any known food allergies.

Patient Q&A Section

What are common treatments for healthy subjects (hs)?

"Hs commonly undergo CT and MR to screen for cardiovascular disease. Most Hs do not report having a cholesterol screening before their CT, indicating a low awareness for common screening tests and a high rate of undiagnosed CAD. However, some Hs report cardiovascular diseases have a positive association with their CAD risk. Hs may report not receiving screenings or receiving only CT without a recommendation for further test is unclear. Cardiovascular risk reduction in Hs is imperative to reduce CAD and CVD morbidity and mortality. Most Hs should consider receiving screenings for CAD and CVD and receive recommendations for further tests." - Anonymous Online Contributor

Unverified Answer

What causes healthy subjects (hs)?

"Healthy subjects are more susceptible to disease due to their reduced ability to recover from adverse changes or challenges in their environment. If HSD participants develop a disease such as heart disease, it is more likely to develop early (i.e., nonlinear) rather than late (i.e., logistic"growth" or LGL) or delayed (i.e., power law"growth" type) in their recovery and in their subsequent aging. This difference in recovery from illness or aging is more significant, if not more important, in HSD individuals than in non-HSD individuals." - Anonymous Online Contributor

Unverified Answer

What is healthy subjects (hs)?

"Healthy subjects (hs) in a study are people without any known illness or injury who are considered representative of a common population of healthy controls. Hs are used to improve the validity of study assessments and control for some sources of error. To find clinical trials investigating common health conditions requiring treatment, use Power." - Anonymous Online Contributor

Unverified Answer

What are the signs of healthy subjects (hs)?

"There are several signs that health conscious people (hs) have that are not apparent to health professionals. The signs are not related to what a person eats, how much they exercise, etc. There are many possible causes, but these changes may be a symptom of something else. There is a general tendency for signs of aging and disease to increase in prominence. We encourage health-conscious individuals to use medical professionals in search of their cause for any new signs they encounter. These signs might be just a symptom of another medical problem." - Anonymous Online Contributor

Unverified Answer

How many people get healthy subjects (hs) a year in the United States?

"There are an average of 9,624 new healthy subjects biennially reported in the US. This finding suggests that most populations in the US are at low risk for developing chronic disease, potentially including risk factors for common diseases of aging." - Anonymous Online Contributor

Unverified Answer

Can healthy subjects (hs) be cured?

"Data from a recent study provides the first proof that patients with persistent subclinical hyperarousal have abnormal connectivity in the Cpn. We find that the altered connectivity pattern as seen in hyperarousal patients during sleep is a trait marker of hyperarousal, rather than a consequence of the disease. This suggests that the trait marker may be a vulnerability marker in a familial way. Further investigations, using a larger sample size, are needed to confirm our claim that persistent subclinical hyperarousal could be objectively considered a trait marker." - Anonymous Online Contributor

Unverified Answer

Is pea fiber safe for people?

"Pea and bean food consumption is a safe dietary behavior for the majority of individuals. However, the present study did not find any difference in the tolerability of pea protein in children or adults." - Anonymous Online Contributor

Unverified Answer

What does pea fiber usually treat?

"In the clinical study, patients with pea fiber supplement showed a decreased blood lipids/fat and lipid peroxidation in their blood whereas patients with regular coffee showed no significant difference." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets healthy subjects (hs)?

"Findings from a recent study supports the hypothesis that hs who are currently young for their age could represent a particular high-risk population for poor health outcomes in adulthood." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating healthy subjects (hs)?

"The present study did not show any significant differences among hs and nhs at baseline, or at one and four months of treatment with fimoxan, mirtazapine, and quetiapine. The study underscores the relevance and need to identify new medicines, and also the need for clinical studies to evaluate these new treatments for hs." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for healthy subjects (hs)?

"Most healthy subjects are willing to participate in a clinical trial if it is a reasonable alternative to routine exams for a specific medical indication or to a healthy lifestyle intervention." - Anonymous Online Contributor

Unverified Answer

Is pea fiber typically used in combination with any other treatments?

"Pea fiber may improve the absorption and bioavailability of nutrients, the bioactivity of drugs, and help the metabolism of anti-obesity drugs, however it was not demonstrated that pea fiber increased appetite, waist circumference, BMI or fasting plasma glucose." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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