MicrobiotaDININGNCT04538482
DASH INtervention to INvestigate the Gut
A study testing DASH Diet and standard American diet in people with Microbiota and Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Cancer
- 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
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- black or white race
- non-Hispanic ethnicity
- age 19-65 years
- able to travel to the UAB Bionutrition Unit daily to retrieve meals
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
- smoking/tobacco use
- heavy alcohol consumption
- major medical conditions (e.g., renal disease, diabetes, cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults
The study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
- Conditions
- Microbiota, Cancer
- Being tested
- DASH Diet, standard American diet
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH DietBehavioural
Participant will receive foods following the DASH dietary pattern for 28 days.
standard American dietBehavioural
Participants will receive foods following the standard American diet for 28 days.
| 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 change in alpha diversity
The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Measured: baseline - day 28
Mean change in alpha diversity
The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Measured: day 28 - day 42
Diet specific changes in secondary bile acids
The investigators will calculate changes in cholic acid in milligrams
Measured: baseline - day 28
Diet specific changes in secondary bile acids
The investigators will calculate changes in cholic acid in milligrams
Measured: day 28 - day 42
Diet-specific changes in inflammatory marker
The investigators will calculate changes in interleukin-6 in pg/L
Measured: baseline - day 28
Diet-specific changes in inflammatory marker
The investigators will calculate changes in interleukin-6 in pg/L
Measured: day 28 - day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start7 Mar 2022
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tiffany L Carson, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538482
- Sponsor's protocol ID
- MCC-21224
- Other IDs
- R01CA253219
- Acronym
- DINING
- Status last verified
- May 2026
- First submitted
- 29 Aug 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carson TL, Buro AW, Miller D, Pena A, Ard JD, Lampe JW, Yi N, Lefkowitz E, William VP, Morrow C, Wilson L, Barnes S, Demark-Wahnefried W. Rationale and study protocol for a randomized controlled feeding study to determine the structural- and functional-level effects of diet-specific interventions on the gut microbiota of non-Hispanic black and white adults. Contemp Clin Trials. 2022 Dec;123:106968. doi: 10.1016/j.cct.2022.106968. Epub 2022 Oct 18.
PubMed 36265810
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the structural-and Functional-level Effects of Diet-specific Interventions on the Gut-microbiota of a Diverse Sample of Southern United States Adults
- ClinicalTrials.gov ID
- NCT04538482
- Acronym / sponsor ID
- DINING / MCC-21224
- Conditions
- Microbiota, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 4 Sep 2020 (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 study investigators will recruit a generally healthy sample of 112 black and white adults from Birmingham, AL to participate in a 28-day randomized, controlled feeding study. Participants will be randomized to receive either the DASH diet or a standard American diet. All meals will be provided by the study. Fecal samples will be collected at multiple time points before, during, and after the dietary intervention and will be analyzed using PCR to amplify the V4 region of the 16S rRNA gene and to sequence bases using the MiSeq platform. Sequenced data will then be analyzed using QIIME. The investigators hypothesize that participants receiving the DASH diet will have a greater increase in alpha diversity and greater changes in abundances of CRC-associated microbes than participants receiving the standard American diet. The investigators will also evaluate functional-level markers including bile acid and short chain fatty acid (SCFA) production and inflammatory markers. If the investigator's hypothesis is supported, they expect to see reduced production of secondary bile acids (e.g., deoxycholic acid), greater SCFA production (e.g, butyrate), and reduction in gut and systemic inflammation (e.g, calprotectin, IL-6) among participants receiving the DASH diet compared to the standard American diet. The investigator's findings will provide preliminary evidence for the DASH diet as an approach for cultivating a healthier gut microbiota across racially diverse populations. These findings can impact clinical, translational, and population-level approaches for modification of the gut microbiota to reduce risk of chronic diseases like CRC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- 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
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- black or white race
- non-Hispanic ethnicity
- age 19-65 years
- able to travel to the UAB Bionutrition Unit daily to retrieve meals
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
- smoking/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 DietParticipant will receive foods following the DASH dietary pattern for 28 days. | Behavioural | DASH Diet |
| standard American dietParticipants will receive foods following the standard American diet for 28 days. | Behavioural | standard American diet |
Primary outcome
Mean change in alpha diversity
Time frame: baseline - day 28
The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Mean change in alpha diversity
Time frame: day 28 - day 42
The investigators will assess the difference in alpha diversity determined by analyzing fecal samples.
Diet specific changes in secondary bile acids
Time frame: baseline - day 28
The investigators will calculate changes in cholic acid in milligrams
Diet specific changes in secondary bile acids
Time frame: day 28 - day 42
The investigators will calculate changes in cholic acid in milligrams
Diet-specific changes in inflammatory marker
Time frame: baseline - day 28
The investigators will calculate changes in interleukin-6 in pg/L
Diet-specific changes in inflammatory marker
Time frame: day 28 - day 42
The investigators will calculate changes in interleukin-6 in pg/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 36265810Carson TL, Buro AW, Miller D, Pena A, Ard JD, Lampe JW, Yi N, Lefkowitz E, William VP, Morrow C, Wilson L, Barnes S, Demark-Wahnefried W. Rationale and study protocol for a randomized controlled feeding study to determine the structural- and functional-level effects of diet-specific interventions on the gut microbiota of non-Hispanic black and white adults. Contemp Clin Trials. 2022 Dec;123:106968. doi: 10.1016/j.cct.2022.106968. Epub 2022 Oct 18.
- 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. This study is not recruiting at the moment.
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 Microbiota and Cancer, 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 4 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: finished, as of the sponsor's last update on 6 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in alpha diversity (time frame: baseline - day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04538482, which also lists 1 linked publication.
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 6 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.