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Dietary Supplement

High Fiber Diet for Microbial Response (TRIUMPH Trial)

N/A

Recruiting

Led By Yezaz Ghouri, MD

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A large waistline: 35 inches or more for women 40 inches or more for men

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

TRIUMPH Trial Summary

This trial aims to understand how people respond to different diets and how it affects their gut microbes, glucose levels and lipids.

Who is the study for?

This trial is for men and women aged 45-65, with a BMI between 20.0 and 40.0, who have had stable weight recently, are scheduled for a screening colonoscopy, and are willing to eat a high-fiber diet or their usual diet. It's not open to diabetics but includes those with metabolic syndrome.Check my eligibility

What is being tested?

The study compares the effects of a high-fiber diet against participants' normal diets on gut microbes in healthy individuals undergoing health screenings. It will also look at changes in blood glucose and lipids after eating high fiber.See study design

What are the potential side effects?

While not explicitly stated, potential side effects from dietary changes may include gastrointestinal discomfort such as bloating or gas due to increased fiber intake.

TRIUMPH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My waistline is over 35 inches (women) or 40 inches (men).

TRIUMPH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Concentration of SCFA

Variability in microbial composition as measured by 'alpha diversity'

Secondary outcome measures

Blood glucose concentration (mg/dL)

Blood lipid concentration (mg/dL)

TRIUMPH Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High FiberExperimental Treatment1 Intervention

Subjects are provided a high-fiber diet for 2 weeks. Tests include: blood biochemistries, body composition measured via DEXA, fecal sample collection, and anthropometrics measured

Group II: ControlActive Control1 Intervention

Subjects are not provided any diet, instead they eat what they choose for two weeks while they participate in a series of tests including: fecal sampling, food records, questionnaires/surveys, and anthropometrics

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

High fiber

2019

N/A

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

362 Previous Clinical Trials

628,034 Total Patients Enrolled

1 Trials studying Microbial Colonization

100 Patients Enrolled for Microbial Colonization

Yezaz Ghouri, MDPrincipal InvestigatorUniversity of Missouri-Columbia

Elizabeth ParksPrincipal InvestigatorUniversity of Missouri-Columbia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this study restricted to individuals aged eighteen or older?

"For eligibility in this trial, participants must be of middle age, ranging from 45 to 65 years old."

Answered by AI

Who has been granted authorization to participate in this experiment?

"This medical research is currently accepting around 80 patients who are between 45 and 65 years of age, and possess microbial colonization."

Answered by AI

Could you provide an estimate of the population size encompassed by this clinical research?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently enrolling patients, having been first published on May 12th 2022 and updated as recently as August 28th 2023. 80 participants are being sought from 1 location."

Answered by AI

Are researchers currently accepting new participants for this clinical trial?

"As of today, clinicaltrials.gov states that this medical research is actively seeking participants with the initial post dating back to May 12th 2022 and updates as recent as August 28th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Variability in Microbial Response to Dietary Fiber

Elizabeth Parks 2022. "Variability in Microbial Response to Dietary Fiber". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023940.

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