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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the DASH Diet treatment for gut health?

The DASH Diet, known for lowering blood pressure and improving heart health, encourages eating more fruits, vegetables, and lean proteins while reducing salt and unhealthy fats. This approach not only helps with hypertension but also improves other heart-related risk factors, which might indirectly benefit gut health by promoting a balanced diet. ^{1 2 3 4 5}

Is the DASH diet generally safe for humans?

The DASH diet is generally safe for most people and can be adopted alongside medication and other lifestyle changes. However, caution is advised for individuals with chronic kidney or liver disease, and those on certain medications, as modifications may be needed. ^{6 7 8 9 10}

How is the DASH Diet treatment unique for gut health?

The DASH Diet is unique because it focuses on a high intake of fruits, vegetables, whole grains, and unsaturated fats, which are known to improve heart health and may also benefit gut health by reducing inflammation and supporting a healthy gut microbiome. Unlike other treatments, it uses regular foods available at most grocery stores, making it accessible and easy to follow. ^{3 8 9 11 12}

Research Team

Tiffany Carson, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Compliance with the Dietary Approaches to Stop Hypertension (DASH) diet: a systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017]

4. United States 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. [2022]

5. Iran pubmed.ncbi.nlm.nih.gov

The Association between DASH Diet Adherence and Cardiovascular Risk Factors. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

7. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Effects of salt intake on blood pressure in banovici coal mine workers. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Degree of concordance with DASH diet guidelines and incidence of hypertension and fatal cardiovascular disease. [2018]

9. India 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. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. United States pubmed.ncbi.nlm.nih.gov

Mediterranean and Dietary Approaches to Stop Hypertension dietary patterns and risk of sudden cardiac death in postmenopausal women. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

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