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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 belowSelect...
I am between 19 and 65 years old.
Select...
I can visit the Bionutrition Unit every day.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a major medical condition like kidney disease, diabetes, or cancer.
Select...
I have a condition affecting my digestive system, such as IBS, Crohn's, or stomach ulcers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to day 42
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 42
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 moreAwards & 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
567 Previous Clinical Trials
144,867 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently drink a lot of alcohol.I am between 19 and 65 years old.I have not taken antibiotics or probiotics in the last 90 days.You smoke or use tobacco products.I have a major medical condition like kidney disease, diabetes, or cancer.I can visit the Bionutrition Unit every day.I am female.I have a condition affecting my digestive system, such as IBS, Crohn's, or stomach ulcers.Only people who identify as black, white or non-Hispanic can participate.
Research Study Groups:
This trial has the following groups:- Group 1: standard American diet
- Group 2: DASH diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT03924778 — N/A