1. OmniHeart Feeding Study Presented at The American Heart Association Scientific Session 2005 Presented by Dr. Lawrence J. Appel OmniHeart Feeding Study

2. www. Clinical trial results.org OmniHeart Feeding Study: Background A diet rich in carbohydrates that emphasizes fruits, vegetables, and low-fat dairy products, while minimizing sodium intake, saturated fat, total fat, and cholesterol could substantially lower blood pressure (DASH trials).A diet rich in carbohydrates that emphasizes fruits, vegetables, and low-fat dairy products, while minimizing sodium intake, saturated fat, total fat, and cholesterol could substantially lower blood pressure (DASH trials). Presented at AHA 2005

3. www. Clinical trial results.org Standard DASH Diet Standard carbohydrates (58%), protein (15%), fat (27%) Standard DASH Diet Standard carbohydrates (58%), protein (15%), fat (27%) OmniHeart Feeding Study: Study Design Presented at AHA 2005 161 patients age >30 years; systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg 45% female, mean age 53.6 years, 930 patients screened Randomized. Crossover. 161 patients age >30 years; systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg 45% female, mean age 53.6 years, 930 patients screened Randomized. Crossover. Primary Endpoint: Systolic blood pressure and LDL cholesterol at the end of each diet period. Primary Endpoint: Systolic blood pressure and LDL cholesterol at the end of each diet period. Secondary Endpoint: Diastolic blood pressure, trigylcerides, and HDL cholesterol at the end of each diet period. Secondary Endpoint: Diastolic blood pressure, trigylcerides, and HDL cholesterol at the end of each diet period. Primary Endpoint: Systolic blood pressure and LDL cholesterol at the end of each diet period. Primary Endpoint: Systolic blood pressure and LDL cholesterol at the end of each diet period. Secondary Endpoint: Diastolic blood pressure, trigylcerides, and HDL cholesterol at the end of each diet period. Secondary Endpoint: Diastolic blood pressure, trigylcerides, and HDL cholesterol at the end of each diet period. Patients were on assigned diet for 6 weeks, where they ate prepared meals on-site during weekdays and ate prepared meals off-site during weekends. Following 6 week diet period, participants ate their own food for 2-4 weeks, after which time participants crossed over to the next diet. Protein Modified DASH Diet carbohydrates (48%), protein (25%), fat (27%) Protein Modified DASH Diet carbohydrates (48%), protein (25%), fat (27%) Unsaturated Fat Modified DASH Diet carbohydrates (48%), protein (15%), fat (37%) monounsat. (21%), polyunsat. (10%), sat. (6%) Unsaturated Fat Modified DASH Diet carbohydrates (48%), protein (15%), fat (37%) monounsat. (21%), polyunsat. (10%), sat. (6%)

4. www. Clinical trial results.org OmniHeart Feeding Study: Weight Presented at AHA 2005 Mean baseline BMI was 30.2 kg/m 2 and weight was 87.3 kgMean baseline BMI was 30.2 kg/m 2 and weight was 87.3 kg Weight did not change with the different diets (86.3 kg vs 86.0 kg vs 86.7 kg)Weight did not change with the different diets (86.3 kg vs 86.0 kg vs 86.7 kg) Measured weight at the end of each diet period (kg) kg

5. www. Clinical trial results.org OmniHeart Feeding Study : Primary Endpoint Systolic blood pressure (mmHg) Presented at AHA 2005 Systolic blood pressure was reduced with all three diets, but the reduction was greater among the protein diet (- 9.5 mmHg; p=0.002) and unsaturated fat diet (-9.3 mmHg; p=0.005) compared with the carbohydrate diet (-8.2 mmHg)Systolic blood pressure was reduced with all three diets, but the reduction was greater among the protein diet (- 9.5 mmHg; p=0.002) and unsaturated fat diet (-9.3 mmHg; p=0.005) compared with the carbohydrate diet (-8.2 mmHg) Unsaturated fat modified Protein modified Standard carbohydrate mmHg

6. www. Clinical trial results.org OmniHeart Feeding Study : Primary Endpoint LDL (mg/dL) Presented at AHA 2005 LDL reductions were greater with the protein diet (-14.2 mg/dL, p=0.01) and non-significantly with the unsaturated fat diet (-13.1 mg/dL, p=0.20) compared with the carbohydrate diet (-11.6 mg/dL)LDL reductions were greater with the protein diet (-14.2 mg/dL, p=0.01) and non-significantly with the unsaturated fat diet (-13.1 mg/dL, p=0.20) compared with the carbohydrate diet (-11.6 mg/dL) Standard carbohydrate Unsaturated fat modified Protein modified mg/dL

7. www. Clinical trial results.org OmniHeart Feeding Study : Secondary Endpoint Diastolic blood pressure (mmHg) Presented at AHA 2005 Diastolic blood pressure was reduced with all three diets, but the reduction was greater among the protein diet (-5.2 mmHg; p<0.001) and unsaturated fat diet (- 4.8 mmHg; p=0.02) compared with the carbohydrate diet (-4.1 mmHg)Diastolic blood pressure was reduced with all three diets, but the reduction was greater among the protein diet (-5.2 mmHg; p<0.001) and unsaturated fat diet (- 4.8 mmHg; p=0.02) compared with the carbohydrate diet (-4.1 mmHg) Unsaturated fat modified Protein modified Standard carbohydrate mmHg

8. www. Clinical trial results.org OmniHeart Feeding Study : Secondary Endpoint Trigylcerides (mg/dL) Presented at AHA 2005 Triglyceride levels were reduced among the protein diet (-16.4 mg/dL; p<0.05) and unsaturated fat diet (- 9.3 mg/dL; p<0.05) compared with the carbohydrate diet (+0.1 mg/dL)Triglyceride levels were reduced among the protein diet (-16.4 mg/dL; p<0.05) and unsaturated fat diet (- 9.3 mg/dL; p<0.05) compared with the carbohydrate diet (+0.1 mg/dL) Unsaturated fat modified Protein modified Standard carbohydrate mg/dL

9. www. Clinical trial results.org OmniHeart Feeding Study : Total Cholesterol Total cholesterol (mg/dL) Presented at AHA 2005 Unsaturated fat modified Protein modified Standard carbohydrate Total cholesterol was reduced with all three diets, but the reduction was greater among the protein diet (-19.9 mg/dL; p<0.05) and unsaturated fat diet (-15.4 mg/dL; p<0.05) compared with the carbohydrate diet (-12.4 mg/dL)Total cholesterol was reduced with all three diets, but the reduction was greater among the protein diet (-19.9 mg/dL; p<0.05) and unsaturated fat diet (-15.4 mg/dL; p<0.05) compared with the carbohydrate diet (-12.4 mg/dL) mg/dL

10. www. Clinical trial results.org OmniHeart Feeding Study : Estimated 10 Year Coronary Heart Disease Risk (based on the Framingham risk score) Estimated 10 year coronary heart disease risk (%) Presented at AHA 2005 Estimated 10 year coronary heart disease risk based on the Framingham risk score was lowered by 16% for the carbohydrate diet, 21% for the protein diet, 20% for the unsaturated fat diet.Estimated 10 year coronary heart disease risk based on the Framingham risk score was lowered by 16% for the carbohydrate diet, 21% for the protein diet, 20% for the unsaturated fat diet. Unsaturated fat modified Protein modified Standard carbohydrate %

11. www. Clinical trial results.org OmniHeart Feeding Study: Limitations Neither the protein nor the fat diet can be advocated over the other because both results showed similar risk scoresNeither the protein nor the fat diet can be advocated over the other because both results showed similar risk scores Future trials should consider the following:Future trials should consider the following: – A fat modified diet with a greater emphasis on polyunsaturated fats. –A focus on weight loss, instead of maintaining study participants at the same weight. –A closer look into different fiber, protein, and carbohydrate sources and their cumulative effect on risk score. Neither the protein nor the fat diet can be advocated over the other because both results showed similar risk scoresNeither the protein nor the fat diet can be advocated over the other because both results showed similar risk scores Future trials should consider the following:Future trials should consider the following: – A fat modified diet with a greater emphasis on polyunsaturated fats. –A focus on weight loss, instead of maintaining study participants at the same weight. –A closer look into different fiber, protein, and carbohydrate sources and their cumulative effect on risk score. Presented at AHA 2005

12. www. Clinical trial results.org OmniHeart Feeding Study: Summary Among individuals with hypertension or prehypertension, use of a modified reduced carbohydrate DASH diet was associated with greater reductions in blood pressure and lipid parameters compared with use of the standard DASH diet.Among individuals with hypertension or prehypertension, use of a modified reduced carbohydrate DASH diet was associated with greater reductions in blood pressure and lipid parameters compared with use of the standard DASH diet. The DASH diet, which is low in saturated and total fat, has been shown in previous randomized trials to be effective for reducing blood pressure and lipid parameters. However, a substantial portion of the DASH diet is made up of carbohydrates. The present study confirms the blood pressure and lipid reductions found in earlier trials with the standard DASH diet, but also showed additional reductions are possible by substituting more protein or unsaturated fats for some of the carbohydrates.The DASH diet, which is low in saturated and total fat, has been shown in previous randomized trials to be effective for reducing blood pressure and lipid parameters. However, a substantial portion of the DASH diet is made up of carbohydrates. The present study confirms the blood pressure and lipid reductions found in earlier trials with the standard DASH diet, but also showed additional reductions are possible by substituting more protein or unsaturated fats for some of the carbohydrates. It should be noted that the trial was conducted in a controlled manner in which all weekday meals were prepared and consumed on-site. Weight was maintained at a stable level in order to remove possible confounding of weight loss on the interpretation of the effect of the diet modification on the results.It should be noted that the trial was conducted in a controlled manner in which all weekday meals were prepared and consumed on-site. Weight was maintained at a stable level in order to remove possible confounding of weight loss on the interpretation of the effect of the diet modification on the results. Among individuals with hypertension or prehypertension, use of a modified reduced carbohydrate DASH diet was associated with greater reductions in blood pressure and lipid parameters compared with use of the standard DASH diet.Among individuals with hypertension or prehypertension, use of a modified reduced carbohydrate DASH diet was associated with greater reductions in blood pressure and lipid parameters compared with use of the standard DASH diet. The DASH diet, which is low in saturated and total fat, has been shown in previous randomized trials to be effective for reducing blood pressure and lipid parameters. However, a substantial portion of the DASH diet is made up of carbohydrates. The present study confirms the blood pressure and lipid reductions found in earlier trials with the standard DASH diet, but also showed additional reductions are possible by substituting more protein or unsaturated fats for some of the carbohydrates.The DASH diet, which is low in saturated and total fat, has been shown in previous randomized trials to be effective for reducing blood pressure and lipid parameters. However, a substantial portion of the DASH diet is made up of carbohydrates. The present study confirms the blood pressure and lipid reductions found in earlier trials with the standard DASH diet, but also showed additional reductions are possible by substituting more protein or unsaturated fats for some of the carbohydrates. It should be noted that the trial was conducted in a controlled manner in which all weekday meals were prepared and consumed on-site. Weight was maintained at a stable level in order to remove possible confounding of weight loss on the interpretation of the effect of the diet modification on the results.It should be noted that the trial was conducted in a controlled manner in which all weekday meals were prepared and consumed on-site. Weight was maintained at a stable level in order to remove possible confounding of weight loss on the interpretation of the effect of the diet modification on the results. Presented at AHA 2005