DASH Diet for Gut Health

(DINING Trial)

Overseen By Alissa Pena

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Antibiotics, Probiotics

Disqualifiers: GI conditions, Smoking, Heavy alcohol, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets might affect gut health. Participants will follow either the DASH diet (Dietary Approaches to Stop Hypertension), rich in fruits, vegetables, and low-fat dairy, or a standard American diet. Researchers aim to determine if the DASH diet can promote a healthier gut by increasing beneficial bacteria and reducing inflammation. The trial seeks generally healthy Black or White individuals who can pick up meals daily in Birmingham, AL. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on diet and gut health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using antibiotics or probiotics, you must not have used them in the previous 90 days to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the DASH diet offers significant health benefits. It is often rated as the best diet for heart health and managing high blood pressure. Studies suggest that most people, including those with some kidney issues, can safely follow the DASH diet.

Although studies do not highlight specific safety concerns, dietary changes can affect individuals differently. However, the DASH diet is generally considered safe and easy for many to follow. It emphasizes balanced nutrition with a good mix of fats, carbohydrates, and protein, and it is high in fiber. This makes it a popular choice for those seeking to improve their diet and overall health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DASH Diet for gut health because it focuses on a unique combination of nutrients that could positively impact digestive wellness. Unlike the standard American diet, which is higher in fat and lower in fiber, the DASH Diet is rich in fiber and lower in fat, which may help improve gut flora and overall digestive health. With its emphasis on a balanced intake of carbohydrates, proteins, and fats, along with increased fiber, this approach offers a fresh perspective on managing gut health through dietary changes.

What evidence suggests that this trial's diets could be effective for improving gut health?

This trial will compare the DASH diet with the standard American diet to assess their effects on gut health. Research has shown that the DASH diet can improve gut health by supporting a variety of beneficial bacteria in the stomach. Studies have found that this diet can lower cholesterol and blood pressure, which are linked to better overall health. It also reduces harmful substances in the gut and increases beneficial ones, which are important for gut health. Additionally, the DASH diet may lower inflammation in the body, reducing the risk of long-term diseases like colorectal cancer. Overall, strong evidence supports the DASH diet's benefits for both heart and gut health. ^{5 6 7 8 9}

Who Is on the Research Team?

Tiffany Carson, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

non-Hispanic ethnicity

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

I am between 19 and 65 years old.

Exclusion Criteria

You drink a lot of alcohol.

You smoke or use tobacco products.

I have a gastrointestinal condition like IBS, Crohn's, or GI cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the DASH diet or a standard American diet for 28 days. All meals are provided by the study.

4 weeks

Multiple visits for meal provision and sample collection

Follow-up

Participants are monitored for changes in secondary bile acids and inflammatory markers after the dietary intervention

2 weeks

Sample collection visits

What Are the Treatments Tested in This Trial?

Interventions

• DASH Diet
• standard American diet

Trial Overview 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.

How Is the Trial Designed?

Group I: DASH Diet Experimental Treatment 1 Intervention

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

Group II: standard American diet Active Control 1 Intervention

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

DASH Diet is already approved in United States, European Union for the following indications:

Approved in United States as DASH Diet for:

• Hypertension
• Weight Loss
• Chronic Disease Prevention

Approved in European Union as DASH Diet for:

• Hypertension
• Cardiovascular Health
• Weight Management

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Following the DASH diet, which is rich in fiber, nutrients, and antioxidants, is linked to a lower prevalence of various cancers, suggesting it may have protective effects against cancer development.

While this review indicates a positive association between the DASH diet and cancer prevention, further longitudinal studies are needed to clarify the exact relationship due to the complex interactions among different foods and nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary approach to stop hypertension (DASH): diet components may be related to lower prevalence of different kinds of cancer: A review on the related documents. Onvani, S., Haghighatdoost, F., Azadbakht, L.[2020]

The DASH diet, which emphasizes fruits, vegetables, nuts, and low-fat dairy while reducing saturated fats, led to an average reduction of 6 mmHg in systolic and 3 mmHg in diastolic blood pressure among patients, with even greater reductions in those with high blood pressure.

These significant blood pressure reductions were observed within just 2 weeks of starting the diet, indicating its potential effectiveness for managing hypertension in a primary care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to Stop Hypertension (DASH) in clinical practice: a primary care experience. Kolasa, KM.[2020]

In a study of 93,122 postmenopausal women followed for an average of 10.5 years, a higher adherence to the Mediterranean diet was linked to a significantly lower risk of sudden cardiac death (SCD), with a hazard ratio of 0.64 for those in the highest quintile compared to the lowest.

The DASH diet did not show a significant association with SCD risk, possibly due to inadequate characterization of sodium intake, which is a key component of the DASH dietary pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediterranean and Dietary Approaches to Stop Hypertension dietary patterns and risk of sudden cardiac death in postmenopausal women. Bertoia, ML., Triche, EW., Michaud, DS., et al.[2023]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

In a study of 20,993 women aged 55 to 69, a greater adherence to the DASH diet was linked to a lower incidence of self-reported hypertension, suggesting a potential protective effect against developing high blood pressure.

However, after adjusting for other risk factors, the study found little evidence that adherence to the DASH diet independently influenced long-term mortality from cardiovascular diseases, indicating that achieving very high concordance with the diet may be necessary for significant health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Degree of concordance with DASH diet guidelines and incidence of hypertension and fatal cardiovascular disease. Folsom, AR., Parker, ED., Harnack, LJ.[2018]

In a study of 2700 miners at Banovici coal mine, 25.7% were found to have arterial hypertension, highlighting a significant health concern in this population.

The average salt intake per meal for these miners ranged from 4-9 grams, exceeding the daily recommended limits set by the American College of Cardiology and American Heart Association, which could contribute to their high blood pressure rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of salt intake on blood pressure in banovici coal mine workers. Becarevic, M., Salihefendic, N., Zildzic, M.[2020]

A study involving 329 participants showed that following the DASH diet for 8 weeks resulted in significant changes in serum concentrations of 44 metabolites compared to a control diet and a fruit and vegetables diet, indicating the diet's impact on metabolic health.

The research identified a specific panel of 10 metabolites that can effectively distinguish adherence to the DASH diet, suggesting potential for these metabolites to be used as biomarkers for dietary assessment in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. Rebholz, CM., Lichtenstein, AH., Zheng, Z., et al.[2023]

The DASH diet is effective in lowering blood pressure, but studies show that compliance with the diet is often suboptimal, especially in educational interventions compared to controlled feeding trials.

There is no consensus on the best method to assess compliance with the DASH diet, highlighting the need for more effective strategies to maintain adherence beyond just dietary counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. Kwan, MW., Wong, MC., Wang, HH., et al.[2023]

The OmniHeart study is a randomized crossover trial involving 160 adults with prehypertension or Stage 1 hypertension, designed to compare the effects of a carbohydrate-rich diet with diets high in protein or unsaturated fat on blood pressure and cholesterol levels.

The study aims to provide insights into how different macronutrient compositions can influence cardiovascular risk factors, potentially guiding dietary recommendations for better heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). Carey, VJ., Bishop, L., Charleston, J., et al.[2017]

A study of 2,831 adults in Iran found that adherence to the DASH diet is associated with lower levels of cardiovascular risk factors, including blood pressure, fasting blood sugar, triglycerides, and cholesterol.

Specifically, individuals in the highest quintile of DASH diet adherence had a 28% lower odds of hyperglycemia, suggesting that the DASH diet may be effective in reducing the risk of diabetes and other cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. Shoaibinobarian, N., Danehchin, L., Mozafarinia, M., et al.[2023]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

The DASH diet not only supports cardiovascular health but may also lower the risk of certain cancers and help prevent osteoporosis due to its calcium content from dairy products.

This diet is practical and accessible, consisting of regular foods found in most grocery stores, and aligns with major dietary guidelines from U.S. health organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary interventions on blood pressure: the Dietary Approaches to Stop Hypertension (DASH) trials. Champagne, CM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10551663/

DASH Diet: A Review of Its Scientifically Proven Hypertension ... During the intervention period, the DASH diet group experienced a significant decrease in systolic blood pressure by 11.8 ± 9.3 mmHg and a ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482514/

DASH Diet To Stop Hypertension - StatPearls - NCBI Bookshelf The diet has been tested in several clinical trials and has been shown to lower cholesterol, saturated fats, and blood pressure.

3. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/dash-diet/art-20048456

DASH diet: Healthy eating to lower your blood pressure The DASH diet is a healthy-eating plan designed to help prevent or treat high blood pressure, also called hypertension.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723026210

Adherence to the Dietary Approaches to Stop Hypertension ... In the fully adjusted model, adherence to the DASH diet was associated with a remarkable 57% reduction in the risk of HNC when comparing extreme quartiles (HR ...

5. nutrition.bmj.com nutrition.bmj.com/content/early/2025/06/13/bmjnph-2024-001163.full.pdf

Association between dietary index for gut microbiota and ... The objective of this study was to investigate the potential association between dietary indices of gut microbiota and hypertension using data ...

6. nhlbi.nih.gov nhlbi.nih.gov/education/dash-eating-plan

DASH Eating Plan | NHLBI, NIH It was named “Best Heart-Healthy Diet” and “Best Diet for High Blood Pressure” by U.S. News & World Report in 2025. Find DASH-Friendly Recipes.

7. nhlbi.nih.gov nhlbi.nih.gov/news/2025/nih-supported-dash-diet-named-best-heart-healthy-diet-and-best-diet-high-blood-pressure

NIH-supported DASH diet named “Best Heart-Healthy ... - NHLBI DASH has secured 14 top spots, including being the number 1 rated “Best Heart-Healthy Diet” and “Best Diet for High Blood Pressure” in the 2025 Best Diets ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4377837/

The Dietary Approaches to Stop Hypertension (DASH ... Although there are no data to determine a safe cutoff, in our opinion, the DASH diet may be safely adopted by individuals with eGFR < 60 ml/min/1.73m2 if ...

9. nature.com nature.com/articles/s41598-023-50423-7

The association between dietary approaches to stop ... The DASH diet has been identified as potentially reducing total BMD, while specifically impacting thoracic and pelvic BMD.