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This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.
This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH diet group | Experimental | Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day. |
|
| Attention Control Group | Active Comparator | Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH Diet | Other | 12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). Participants will prepare their own breakfast from a menu.The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of enrolled participants per week | Up to week 12 | |
| Proportion of participants that adhere to the to intervention | Up to week 12 | |
| Number participants that were retained in the trial | Up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants that adhere to the diet | Up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Weight (kilograms) | Baseline |
| Weight | Weight (kilograms) | After intervention, Week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Campos, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000073601 | Dietary Approaches To Stop Hypertension |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Usual diet | Other | 12 weeks usual diet <2300 mg Na/day |
|
| Waist circumference | Waist circumference (cm) | Baseline |
| Waist circumference | Waist circumference (cm) | After intervention, Week 12 |
| Body mass Index (BMI) | Baseline |
| Body mass Index (BMI) | After intervention, Week 12 |
| Systolic Blood Pressure | Baseline |
| Systolic Blood Pressure | After intervention, Week 12 |
| Diastolic Blood Pressure | Baseline |
| Diastolic Blood Pressure | After intervention, Week 12 |
| Total Cholesterol | Baseline |
| LDL Cholesterol | Baseline |
| HDL Cholesterol | Baseline |
| serum creatinine | Baseline |
| Total Cholesterol | After intervention, Week 12 |
| LDL Cholesterol | After intervention, Week 12 |
| HDL Cholesterol | After intervention, Week 12 |
| Serum creatinine | After intervention, Week 12 |
| Left Ventricle mass | Doppler-echocardiograms | Baseline |
| Left Ventricle mass | Doppler-echocardiograms | After intervention, Week 12 |
| Left atrial volume | Doppler-echocardiograms | Baseline |
| Left atrial volume | Doppler-echocardiograms | After intervention, Week 12 |
| Doppler echocardiogram velocity ratio | Baseline |
| Doppler echocardiogram velocity ratio | After intervention, Week 12 |
| CRP | Inflammatory marker | Baseline |
| IL6 | Inflammatory marker | Baseline |
| TNF alpha | Inflammatory marker | Baseline |
| CRP | Inflammatory marker | After intervention, Week 12 |
| IL6 | Inflammatory marker | After intervention, Week 12 |
| TNF alpha | Inflammatory marker | After intervention, Week 12 |
| 6- minute walk test | Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender. | Baseline |
| 6- minute walk test | Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender. | After intervention, Week 12 |
| Plasma nitrate | Baseline |
| Plasma nitrate | After intervention, Week 12 |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |