Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000608
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
1999-10-27
Brief Title:
Dietary Patterns Sodium Intake and Blood Pressure DASH - Sodium
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare the effects of three levels of dietary sodium and two patterns of diet a control diet and an intervention diet high in fruits vegetables and low fat dairy products and low in fat on blood pressure in individuals with higher than optimal blood pressure or with Stage 1 hypertension DASH - Sodium built on and extended the results of the NHLBI-initiated Dietary Approaches to Stop Hypertension DASH study
Detailed Description:
BACKGROUND
High blood pressure defined as systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg or taking antihypertensive medication affects 24 percent of the United States adult population or about 50 million people Because the risk of cardiovascular disease and stroke increases with increasing blood pressure throughout the entire range of blood pressure levels people with blood pressure above the optimal level of 12080 are at increased risk of disease Approximately 48 percent of the adult population have blood pressure either normal but above optimal levels or have Stage 1 hypertension a prevalence which increases with age To combat this highly prevalent condition primary prevention through lifestyle modification represents a highly promising strategy for public health
DASH - Sodium extended research from DASH trial to address several issues of relevance to clinical practice and public health and capitalized on the success of DASH by following the multicenter outpatient feeding study model The model permitted a true test of efficacy because of high adherence and follow-up rates In addition the population studied across four geographic areas encompassing individuals with diastolic blood pressure between 80-95 mm Hg and systolic blood pressure 160 mm Hg was broadly representative thus making the results generalizable to a large portion of the United States population
DESIGN NARRATIVE
The effects on blood pressure of three levels of sodium intake and two dietary patterns were compared The combined impact of sodium reduction with dietary intervention was evaluated as a potential non-pharmacologic treatment alternative to drug therapy for stage one hypertension or for maintaining normal blood pressure levels The two dietary patterns were a control diet that represented the typical American diet and an intervention diet DASH diet that was high in fruits vegetables included whole grains poultry fish and nuts and reduced in fats red meat sweets and sugar-containing beverages and dairy products The three levels of sodium were higher current United States intake intermediate current recommended levels and lower potentially optimal levels Participants were assigned to one of the two dietary patterns using a parallel group design and were fed at each sodium level using a randomized cross-over design
Three eligibility pre-screening visits were followed by a two-week run-in feeding period and then a four-week intervention period at each of three sodium levels During the run-in for the intervention feeding periods all food was provided to participants They were required to attend the clinic for at least one meal per day five days per week and to take home food to eat for other meals Each of the four clinics recruited 100 participants Blood pressure was measured once a week during the first of three weeks and five times during the last week During the final feeding period fasting blood was collected and 24-hour urine collections were analyzed for magnesium potassium calcium sodium and creatinine
DASH - Sodium determined separately by race gender and hypertension status 1 the effects on blood pressure of three levels of dietary sodium within the context of both a control diet and the DASH diet 2 the effect on blood pressure of the DASH diet relative to the control diet at each of the three levels of sodium intake The study also assessed whether the effect on blood pressure of going from higher to lower sodium diets differs for participants in the control and DASH diets Lastly the study determined whether the blood pressure effect associated with reducing sodium from the higher to the intermediate level differs from the blood pressure effect associated with reducing sodium from the intermediate to the lower level that is testing whether the blood pressure effects of sodium are linear across sodium levels for each diet
Recruitment and screening began in August 1997 The first cohort began the experimental diets in January 1998 and the last cohort completed the diets in November 1999 A total of 412 participants were enrolled into the study Results were presented at the annual meeting of American Society of Hypertension in May 2000
The study was renewed under R01HL57114 to to analyze the data of the trial The hypothesis to be tested is that genetic makeup modulates the BP effects of DASH diet and reduced sodium intake through one or more of the following mechanisms 1 effects on vascular tone 2 effects on mineralocorticoid regulation of sodium homeostasis and 3 effects on non-classical regulation of sodium homeostasis
High blood pressure defined as systolic blood pressure greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg or taking antihypertensive medication affects 24 percent of the United States adult population or about 50 million people Because the risk of cardiovascular disease and stroke increases with increasing blood pressure throughout the entire range of blood pressure levels people with blood pressure above the optimal level of 12080 are at increased risk of disease Approximately 48 percent of the adult population have blood pressure either normal but above optimal levels or have Stage 1 hypertension a prevalence which increases with age To combat this highly prevalent condition primary prevention through lifestyle modification represents a highly promising strategy for public health
DASH - Sodium extended research from DASH trial to address several issues of relevance to clinical practice and public health and capitalized on the success of DASH by following the multicenter outpatient feeding study model The model permitted a true test of efficacy because of high adherence and follow-up rates In addition the population studied across four geographic areas encompassing individuals with diastolic blood pressure between 80-95 mm Hg and systolic blood pressure 160 mm Hg was broadly representative thus making the results generalizable to a large portion of the United States population
DESIGN NARRATIVE
The effects on blood pressure of three levels of sodium intake and two dietary patterns were compared The combined impact of sodium reduction with dietary intervention was evaluated as a potential non-pharmacologic treatment alternative to drug therapy for stage one hypertension or for maintaining normal blood pressure levels The two dietary patterns were a control diet that represented the typical American diet and an intervention diet DASH diet that was high in fruits vegetables included whole grains poultry fish and nuts and reduced in fats red meat sweets and sugar-containing beverages and dairy products The three levels of sodium were higher current United States intake intermediate current recommended levels and lower potentially optimal levels Participants were assigned to one of the two dietary patterns using a parallel group design and were fed at each sodium level using a randomized cross-over design
Three eligibility pre-screening visits were followed by a two-week run-in feeding period and then a four-week intervention period at each of three sodium levels During the run-in for the intervention feeding periods all food was provided to participants They were required to attend the clinic for at least one meal per day five days per week and to take home food to eat for other meals Each of the four clinics recruited 100 participants Blood pressure was measured once a week during the first of three weeks and five times during the last week During the final feeding period fasting blood was collected and 24-hour urine collections were analyzed for magnesium potassium calcium sodium and creatinine
DASH - Sodium determined separately by race gender and hypertension status 1 the effects on blood pressure of three levels of dietary sodium within the context of both a control diet and the DASH diet 2 the effect on blood pressure of the DASH diet relative to the control diet at each of the three levels of sodium intake The study also assessed whether the effect on blood pressure of going from higher to lower sodium diets differs for participants in the control and DASH diets Lastly the study determined whether the blood pressure effect associated with reducing sodium from the higher to the intermediate level differs from the blood pressure effect associated with reducing sodium from the intermediate to the lower level that is testing whether the blood pressure effects of sodium are linear across sodium levels for each diet
Recruitment and screening began in August 1997 The first cohort began the experimental diets in January 1998 and the last cohort completed the diets in November 1999 A total of 412 participants were enrolled into the study Results were presented at the annual meeting of American Society of Hypertension in May 2000
The study was renewed under R01HL57114 to to analyze the data of the trial The hypothesis to be tested is that genetic makeup modulates the BP effects of DASH diet and reduced sodium intake through one or more of the following mechanisms 1 effects on vascular tone 2 effects on mineralocorticoid regulation of sodium homeostasis and 3 effects on non-classical regulation of sodium homeostasis
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL057139 | NIH | None | httpsreporternihgovquickSearchU01HL057139 |