ObesityNCT03924778
Modifying Diet to Improve Gut Microbiome
A study testing DASH diet and standard American diet in people with Obesity, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- DASH diet and standard American diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female
- non-Hispanic, black or white
- age 19-65 years
- BMI >= 30 kg/m^2
- able to visit Bionutrition Unit daily
Who cannot join
- gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
- antibiotic or probiotic use in the previous 90 days
- tobacco use
- heavy alcohol consumption
- major medical conditions (e.g., renal disease, diabetes, cancer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Moffit Cancer Center
Tampa, Florida, 33612
Tiffany Carson, PhD, 813-745-4944, Tiffany.Carson@moffitt.org
Tiffany Carson, PhD
About this study
Official title: Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.
- Conditions
- Obesity
- Being tested
- DASH diet, standard American diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietBehavioural
brief description
standard American dietBehavioural
describe
| Study group | Role | What they receive |
|---|---|---|
| DASH diet | Experimental | calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber Receives: Behavioral: DASH diet |
| standard American diet | Active comparator | calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber Receives: Behavioral: standard American diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weight Change of Participants
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Measured: Baseline to day 28
Mean Weight Change of Participants
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Measured: Day 28 to Day 42
Mean Weight Change of Participants
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Measured: Baseline to day 42
Diet-specific changes in secondary bile acid
The investigators will calculate changes in cholic acid in milligrams.
Measured: Baseline to day 28
Diet-specific changes in secondary bile acid
The investigators will calculate changes in cholic acid in milligrams.
Measured: day 28 to day 42
Diet-specific changes in secondary bile acid
The investigators will calculate changes in cholic acid in milligrams.
Measured: baseline to day 42
Diet-specific changes in inflammatory marker
The investigators will calculate changes in c-reactive protein in mg/L.
Measured: baseline to day 28
Diet-specific changes in inflammatory marker
The investigators will calculate changes in c-reactive protein in mg/L.
Measured: day 28 to day 42
Diet-specific changes in inflammatory marker
The investigators will calculate changes in c-reactive protein in mg/L.
Measured: baseline to day 42
Diet-specific changes in short chain fatty acids
The investigators will calculate changes in acetic acid in mmol/L
Measured: baseline to day 28
Diet-specific changes in short chain fatty acids
The investigators will calculate changes in acetic acid in mmol/L
Measured: day 28 to day 42
Diet-specific changes in short chain fatty acids
The investigators will calculate changes in acetic acid in mmol/L
Measured: baseline to day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study startJul 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany L Carson, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924778
- Sponsor's protocol ID
- IRB-300003207
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2019
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Diet and the Gut Microbiota to Reduce Obesity and Health Disparities
- ClinicalTrials.gov ID
- NCT03924778
- Acronym / sponsor ID
- IRB-300003207
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a 2-arm randomized controlled pilot, feasibility feeding study in which 28 participants will be randomized to receive either a calorie-restricted Dietary Approaches to Stop Hypertension (DASH) diet or a calorie-restricted standard American diet provided by the study for 4 weeks. Participants will be non-Hispanic black or white, generally healthy females (14 black, 14 white). The investigators will collect fecal samples at multiple time points before, during, and after the dietary intervention to analyze for changes in the gut microbiota and functional-level metabolic products. This work will be led by an interdisciplinary team including expertise in bio-behavioral science, microbiology, nutrition science, bioinformatics, and biostatistics all with cross-cutting expertise in health disparities, prevention research, nutrition, the gut microbiota, inflammation and other biomarkers. The rationale for the proposed research is that once the interactions between race, diet, and the gut microbiota are more fully understood, targeted diet modifications may provide new and innovative approaches for the prevention and treatment of obesity and obesity-related diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH diet | Experimental | Behavioral: DASH dietcalorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber |
| standard American diet | Active comparator | Behavioral: standard American dietcalorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female
- non-Hispanic, black or white
- age 19-65 years
- BMI >= 30 kg/m^2
- able to visit Bionutrition Unit daily
Key exclusion criteria (5 listed)
- gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps
- antibiotic or probiotic use in the previous 90 days
- tobacco use
- heavy alcohol consumption
- major medical conditions (e.g., renal disease, diabetes, cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DASH dietbrief description | Behavioural | DASH diet |
| standard American dietdescribe | Behavioural | standard American diet |
Primary outcome
Mean Weight Change of Participants
Time frame: Baseline to day 28
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Mean Weight Change of Participants
Time frame: Day 28 to Day 42
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Mean Weight Change of Participants
Time frame: Baseline to day 42
Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged.
Diet-specific changes in secondary bile acid
Time frame: Baseline to day 28
The investigators will calculate changes in cholic acid in milligrams.
Diet-specific changes in secondary bile acid
Time frame: day 28 to day 42
The investigators will calculate changes in cholic acid in milligrams.
Diet-specific changes in secondary bile acid
Time frame: baseline to day 42
The investigators will calculate changes in cholic acid in milligrams.
Diet-specific changes in inflammatory marker
Time frame: baseline to day 28
The investigators will calculate changes in c-reactive protein in mg/L.
Diet-specific changes in inflammatory marker
Time frame: day 28 to day 42
The investigators will calculate changes in c-reactive protein in mg/L.
Diet-specific changes in inflammatory marker
Time frame: baseline to day 42
The investigators will calculate changes in c-reactive protein in mg/L.
Diet-specific changes in short chain fatty acids
Time frame: baseline to day 28
The investigators will calculate changes in acetic acid in mmol/L
Diet-specific changes in short chain fatty acids
Time frame: day 28 to day 42
The investigators will calculate changes in acetic acid in mmol/L
Diet-specific changes in short chain fatty acids
Time frame: baseline to day 42
The investigators will calculate changes in acetic acid in mmol/L
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany L Carson, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DASH diet and standard American diet in people with Obesity, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tiffany L Carson, PhD (813-745-4944, Tiffany.Carson@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Weight Change of Participants (time frame: Baseline to day 28). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.