Trial Outcomes & Findings for Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure (NCT NCT00939640)
NCT ID: NCT00939640
Last Updated: 2019-10-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participation
Results posted on
2019-10-15
Participant Flow
22 patients screened, 14 enrolled
Participant milestones
| Measure |
Dietary Intervention
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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|---|---|
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Overall Study
STARTED
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14
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Overall Study
COMPLETED
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13
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Dietary Intervention
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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|---|---|
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Effects of the Dietary Approaches to Stop Hypertension(DASH) Sodium-restricted Diet in Diastolic Heart Failure
Baseline characteristics by cohort
| Measure |
Dietary Intervention
n=14 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
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14 Participants
n=99 Participants
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Age, Continuous
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72 years
STANDARD_DEVIATION 10 • n=99 Participants
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Sex: Female, Male
Female
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13 Participants
n=99 Participants
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Sex: Female, Male
Male
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1 Participants
n=99 Participants
|
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Region of Enrollment
United States
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14 participants
n=99 Participants
|
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Body mass index
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35.5 kg/m^2
STANDARD_DEVIATION 7.9 • n=99 Participants
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Hypertension
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14 Participants
n=99 Participants
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Participants with Chronic Kidney Disease
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14 Participants
n=99 Participants
|
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Coronary Artery Disease
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5 Participants
n=99 Participants
|
|
Participants wtih Diabetes Mellitus
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6 Participants
n=99 Participants
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|
Participants wtih Anemia
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6 Participants
n=99 Participants
|
|
New York Heart Assocation Classification
NYHA Class III
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12 Participants
n=99 Participants
|
|
New York Heart Assocation Classification
NYHA Class II
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2 Participants
n=99 Participants
|
|
Participants with prior hospitalization due to heart failure
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10 Participants
n=99 Participants
|
|
Participants on chronic loop diuretics
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11 Participants
n=99 Participants
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Participants on 3 or more antihypertensive medications
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10 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationOutcome measures
| Measure |
Pre-dietary Intervention
n=13 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=13 Participants
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|---|---|---|
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Brachial Artery Flow-mediated Dilation (FMD)
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5 % dilation
Standard Deviation 5
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8 % dilation
Standard Deviation 6
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationChange in 24-hour systolic blood pressure
Outcome measures
| Measure |
Pre-dietary Intervention
n=13 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=13 Participants
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|---|---|---|
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Mean 24-hour Systolic Blood Pressure
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130 mm Hg
Standard Deviation 4
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123 mm Hg
Standard Deviation 4
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationNumber of participants with non-dipping of nocturnal blood pressure - nighttime-to-daytime systolic BP ratio of \>= 0.9
Outcome measures
| Measure |
Pre-dietary Intervention
n=13 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=13 Participants
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|---|---|---|
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Diurnal Variation in Ambulatory Blood Pressure
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10 Participants
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7 Participants
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationAortic augmentation index is the ratio of the augmentation pressure to the central pulse pressure, expressed as a percentage. Both parameters are obtained via mathematical transformation of the radial pulse wave. The augmentation pressure represents the contribution of reflected waves to the pulse pressure. The central pulse pressure is the ratio between maximum aortic systolic pressure and minimum aortic diastolic pressure. A higher aortic augmentation index and central pulse pressure reflect increased arterial stiffness. Increased arterial stiffness is associated with an increased long-term risk of cardiovascular disease.
Outcome measures
| Measure |
Pre-dietary Intervention
n=12 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=12 Participants
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|---|---|---|
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Aortic Augmentation Index
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29 percentage
Standard Deviation 9
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28 percentage
Standard Deviation 10
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationOutcome measures
| Measure |
Pre-dietary Intervention
n=11 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=11 Participants
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|---|---|---|
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Carotid-femoral Pulse Wave Velocity
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12.4 m/s
Standard Deviation 3
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11.0 m/s
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationLateral mitral annulus E/e' ratio
Outcome measures
| Measure |
Pre-dietary Intervention
n=12 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=12 Participants
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|---|---|---|
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Ventricular Diastolic Function
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12 ratio
Standard Deviation 2
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11 ratio
Standard Deviation 2
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationOutcome measures
| Measure |
Pre-dietary Intervention
n=13 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=13 Participants
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|---|---|---|
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Six Minute Walk Test Distance
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313 meters
Standard Deviation 86
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337 meters
Standard Deviation 91
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SECONDARY outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationOutcome measures
| Measure |
Pre-dietary Intervention
n=13 Participants
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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Post-dietary Intervention
n=13 Participants
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|---|---|---|
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Urinary 8-isoprostanes
|
70 mmol F2-iso/mmol Cr
Standard Deviation 28
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48 mmol F2-iso/mmol Cr
Standard Deviation 15
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OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to and following 21 days of dietary intervention, i.e. day 1 and day 22 of participationSafety measures to determine adverse effects of the provided DASH diet home-delivered meals
Outcome measures
Outcome data not reported
Adverse Events
Dietary Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dietary Intervention
n=14 participants at risk
Diet patterned after the intervention in the DASH-Sodium trial (Sacks FM et al. New Engl J Med 2001;344(1):3-10). The diet includes higher quantities of fresh fruits and vegetables, whole grain products, and low-fat dairy products than the standard American diet. The target sodium content is 50 mmol per 2100 kcal, and the caloric content is intended to maintain body weight. The diet is designed, prepared, and packaged by research dietitians and all food and beverages are provided for study participants.
DASH/sodium-restricted diet (SRD) : Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the study urinary sodium, potassium, and 8-isoprostanes will again be measured.
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|---|---|
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Metabolism and nutrition disorders
hyperkalemia
|
7.1%
1/14 • Number of events 1 • 25 days
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place