Trial results for the Dietary Approaches to Stop Hypertension for Diabetes (DASH4D) study in Type 2 Diabetes were posted on ClinicalTrials.gov on 2026-05-13, involving 105 participants.
Background
Type 2 Diabetes Mellitus is a chronic condition characterized by high blood sugar levels, often accompanied by other comorbidities such as hypertension. Effective management of Type 2 Diabetes typically involves a combination of lifestyle modifications, including dietary changes, and medication. The Dietary Approaches to Stop Hypertension (DASH) diet is well-established for its efficacy in lowering blood pressure. This trial investigated a modified DASH-style diet tailored for individuals with diabetes (DASH4D) and the impact of varying sodium intake on blood pressure and glucose control, aiming to provide evidence for integrated dietary strategies in managing Type 2 Diabetes.
Trial design
This completed study, designated as Phase NA, enrolled 105 participants with conditions including Diabetes Mellitus, Type 2, Diabetes, Diabetes type2, Type2 Diabetes, and Type 2 Diabetes. The trial was designed as a single-site, 4-period, crossover feeding study, with each period lasting 5 weeks. Participants were fed each of four isocaloric diets in a randomized order. The interventions included a DASH4D diet (a DASH-style diet modified for people with diabetes) compared to a typical American diet for people with diabetes, and lower sodium intake compared to higher sodium intake. The primary contrast of interest was the DASH4D diet with lower sodium versus the comparison diet with higher sodium.
Key results
Key measurements from the trial included:
- Systolic Blood Pressure (SBP):
- DASH4D Diet With Lower Sodium: Mean of 122.4 mmHg (Standard Deviation 13.3)
- DASH4D Diet With Higher Sodium: Mean of 127.2 mmHg (Standard Deviation 13.7)
- Comparison Diet With Lower Sodium: Mean of 124.8 mmHg (Standard Deviation 15.2)
- Comparison Diet With Higher Sodium: Mean of 127.0 mmHg (Standard Deviation 13.5)
- Diastolic Blood Pressure (DBP):
- DASH4D Diet With Lower Sodium: Mean of 67.4 mmHg (Standard Deviation 10.0)
- DASH4D Diet With Higher Sodium: Mean of 69.9 mmHg (Standard Deviation 10.0)
- Comparison Diet With Lower Sodium: Mean of 68.8 mmHg (Standard Deviation 11.2)
- Comparison Diet With Higher Sodium: Mean of 69.4 mmHg (Standard Deviation 9.5)
- Mean Continuous Glucose Monitoring Sensor Glucose:
- DASH4D Diet (Combined DL and DH Diets): Mean of 132.4 mg/dL
- Comparison Diet (Combined CL and CH Diets): Mean of 143.5 mg/dL
- Percentage of Time Glucose Between 70 and 180 mg/dL:
- DASH4D Diet (Combined DL and DH Diets): Mean of 83.0 % time in range
- Comparison Diet (Combined CL and CH Diets): Mean of 77.8 % time in range
Key analyses using Mixed Models Analysis reported the following mean differences (final values):
- The effect of the DASH4D diet versus the comparison diet on SBP was a mean difference of -4.6 (95% Confidence Interval -7.2 to -2.0), with a p-value of 0.001.
- The effect of the DASH4D diet versus the comparison diet on DBP was a mean difference of -2.3 (95% Confidence Interval -3.7 to -0.9).
- The effect of the DASH4D diet versus the comparison diet on mean continuous glucose monitoring sensor glucose was a mean difference of -11.1 (95% Confidence Interval -15.8 to -6.3), with a p-value of 0.001.
- The effect of the DASH4D diet versus the comparison diet on the percentage of time glucose was between 70 and 180 mg/dL was a mean difference of 5.2 (95% Confidence Interval 2.8 to 7.7), with a p-value of 0.001.
- The effect of lower sodium intake versus higher sodium intake on SBP was a mean difference of -3.3 (95% Confidence Interval -4.9 to -1.6).
What this means
The results suggest that the DASH4D diet, particularly when combined with lower sodium intake, can significantly improve blood pressure and glucose control in individuals with Type 2 Diabetes. The observed reductions in both systolic and diastolic blood pressure, alongside favorable changes in glucose metrics such as lower mean sensor glucose and increased time in range, highlight the potential of this dietary approach as a therapeutic intervention. These findings support the integration of a modified DASH-style diet and sodium reduction strategies into the comprehensive management plans for patients with Type 2 Diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study titled "Dietary Approaches to Stop Hypertension for Diabetes" were posted on 2026-05-13 on clinicaltrials.gov.