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DASH Diet for Obesity

N/A
Waitlist Available
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
age 19-65 years
able to visit Bionutrition Unit daily
Must not have
major medical conditions (e.g., renal disease, diabetes, cancer)
gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 42
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether a calorie-restricted diet can help to prevent obesity and obesity-related diseases. The investigators will collect fecal samples to analyze the gut microbiota and functional-level metabolic products.

Who is the study for?
This trial is for non-Hispanic black or white women, aged 19-65 with obesity (BMI >= 30 kg/m^2). Participants must be able to visit the Bionutrition Unit daily. Those who have used antibiotics or probiotics recently, smoke, drink heavily, or have certain GI conditions and major diseases like diabetes cannot join.
What is being tested?
The study compares two diets over four weeks: a calorie-restricted DASH diet versus a standard American diet. It aims to see how these diets affect gut bacteria and metabolism in participants. The results could lead to new dietary strategies for preventing obesity-related health issues.
What are the potential side effects?
While not explicitly stated, potential side effects may include changes in digestion due to new diets such as bloating, gas, constipation or diarrhea. Nutritional deficiencies might occur if the diet does not meet all of the participant's needs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 19 and 65 years old.
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I can visit the Bionutrition Unit every day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a major medical condition like kidney disease, diabetes, or cancer.
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I have a condition affecting my digestive system, such as IBS, Crohn's, or stomach ulcers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 42 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diet-specific changes in inflammatory marker
Diet-specific changes in secondary bile acid
Diet-specific changes in short chain fatty acids
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2010
Completed Phase 4
~1350

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,820 Total Patients Enrolled
1 Trials studying Obesity
340 Patients Enrolled for Obesity
Tiffany L Carson, PhDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
452 Total Patients Enrolled
1 Trials studying Obesity
340 Patients Enrolled for Obesity

Media Library

DASH diet Clinical Trial Eligibility Overview. Trial Name: NCT03924778 — N/A
Obesity Research Study Groups: standard American diet, DASH diet
Obesity Clinical Trial 2023: DASH diet Highlights & Side Effects. Trial Name: NCT03924778 — N/A
DASH diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT03924778 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT03924778 — N/A
~19 spots leftby Jun 2025
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