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DASH Diet for Gut Health (DINING Trial)

N/A

Recruiting

Led By Tiffany L Carson, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

able to travel to the UAB Bionutrition Unit daily to retrieve meals

age 19-65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28 - day 42

Awards & highlights

DINING Trial Summary

This trial is testing whether the DASH diet affects the gut microbiota of black and white adults from Birmingham, Alabama. 112 people will be randomly assigned to either the DASH diet or a standard American diet for 28 days. All meals will be provided by the study. Fecal samples will be collected at multiple time points and analyzed to see if there are changes in the gut microbiota. The investigators will also evaluate functional markers including bile acid and short chain fatty acid production and inflammatory markers.

Who is the study for?

This trial is for non-Hispanic black or white adults, aged 19-65, in Birmingham, AL who can pick up meals daily. It's not for heavy drinkers, smokers, recent antibiotic/probiotic users, or those with GI conditions like IBS or Crohn's disease.Check my eligibility

What is being tested?

The study compares the effects of the DASH diet versus a standard American diet on gut health over 28 days. Participants' fecal samples will be analyzed to see how these diets affect gut bacteria and markers of inflammation and bile acid production.See study design

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include changes in digestion such as discomfort or altered bowel movements as the body adjusts to new eating patterns.

DINING Trial Eligibility Criteria

Inclusion Criteria

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

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I can go to the UAB Bionutrition Unit every day for meals.

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I am between 19 and 65 years old.

DINING Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28 - day 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28 - day 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 - day 42 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Diet specific changes in secondary bile acids

Diet-specific changes in inflammatory marker

Mean change in alpha diversity

DINING Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DASH DietExperimental Treatment1 Intervention

calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber)

Group II: standard American dietActive Control1 Intervention

calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DASH Diet

2014

N/A

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,383 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,793 Total Patients Enrolled

Tiffany L Carson, PhDPrincipal InvestigatorMoffitt Cancer Center

2 Previous Clinical Trials

368 Total Patients Enrolled

Media Library

DASH Diet Clinical Trial Eligibility Overview. Trial Name: NCT04538482 — N/A

Microbiome Research Study Groups: DASH Diet, standard American diet

Microbiome Clinical Trial 2023: DASH Diet Highlights & Side Effects. Trial Name: NCT04538482 — N/A

DASH Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04538482 — N/A

Frequently Asked Questions

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

Is the age limit for this medical trial beyond fifty-five years old?

"The minimum age to qualify for enrollment in this trial is 19 and the upper limit of eligibility is 65."

Answered by AI

Does this research endeavor have any more participants that it seeks to accept?

"Affirmative, the information posted on clinicaltrials.gov states that this medical trial is in need of participants. It was originally put up on March 7th 2022 and most recently edited November 3rd 2022. The research project requires 112 individuals from 1 participating location."

Answered by AI

Am I eligible to become part of this clinical experiment?

"This clinical trial seeks 112 patients between the ages 19 and 65 that have malignancies. Furthermore, these individuals must be of either Caucasian or African American background, non-Hispanic ethnicity, physically able to travel to UAB Bionutrition Unit on a daily basis for meals."

Answered by AI

How many participants is the experimental therapy recruiting?

"Affirmative. The information found on clinicaltrials.gov signifies that this research trial is presently recruiting participants, having first been listed on March 7th 2022 and last updated November 3rd 2022. This project requires 112 individuals across one facility to take part in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DASH INtervention to INvestigate the Gut

2022. "DASH INtervention to INvestigate the Gut". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04538482.