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Dietary Patterns, Sodium Intake and Blood Pressure (DASH - Sodium)

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
diet, fat-restricted
diet, sodium-restricted
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

22 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Healthy adult men and women, ages 22 and older, who had a diastolic blood pressure of 80 to 95 mm Hg and a systolic blood pressure less than 160 mm Hg.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000608
    Brief Title
    Dietary Patterns, Sodium Intake and Blood Pressure (DASH - Sodium)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1997 (undefined)
    Primary Completion Date
    July 2002 (Actual)
    Study Completion Date
    July 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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 120/80 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, fat-restricted
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, sodium-restricted

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Healthy adult men and women, ages 22 and older, who had a diastolic blood pressure of 80 to 95 mm Hg and a systolic blood pressure less than 160 mm Hg.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William Vollmer
    Organizational Affiliation
    Kaiser Foundation Research Institute

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10450301
    Citation
    Svetkey LP, Sacks FM, Obarzanek E, Vollmer WM, Appel LJ, Lin PH, Karanja NM, Harsha DW, Bray GA, Aickin M, Proschan MA, Windhauser MM, Swain JF, McCarron PB, Rhodes DG, Laws RL. The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-sodium): rationale and design. DASH-Sodium Collaborative Research Group. J Am Diet Assoc. 1999 Aug;99(8 Suppl):S96-104. doi: 10.1016/s0002-8223(99)00423-x.
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    11136961
    Citation
    Greenland P. Beating high blood pressure with low-sodium DASH. N Engl J Med. 2001 Jan 4;344(1):53-5. doi: 10.1056/NEJM200101043440109. No abstract available.
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    11136953
    Citation
    Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
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    11747380
    Citation
    Vollmer WM, Sacks FM, Ard J, Appel LJ, Bray GA, Simons-Morton DG, Conlin PR, Svetkey LP, Erlinger TP, Moore TJ, Karanja N; DASH-Sodium Trial Collaborative Research Group. Effects of diet and sodium intake on blood pressure: subgroup analysis of the DASH-sodium trial. Ann Intern Med. 2001 Dec 18;135(12):1019-28. doi: 10.7326/0003-4819-135-12-200112180-00005.
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    Phillips KM, Simpkins AH, Amanna KR, Wolf W, Stewart KK, Clark S, Kim KP, Beecher GR, Holden J. Long-term stability of nutrients in a frozen mixed food control material. Fresenius J Anal Chem. 2001 Jun;370(2-3):297-302. doi: 10.1007/s002160100785.
    Results Reference
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    PubMed Identifier
    12745193
    Citation
    Conlin PR, Erlinger TP, Bohannon A, Miller ER 3rd, Appel LJ, Svetkey LP, Moore TJ. The DASH diet enhances the blood pressure response to losartan in hypertensive patients. Am J Hypertens. 2003 May;16(5 Pt 1):337-42. doi: 10.1016/s0895-7061(03)00056-6.
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    PubMed Identifier
    12669013
    Citation
    Lin PH, Aickin M, Champagne C, Craddick S, Sacks FM, McCarron P, Most-Windhauser MM, Rukenbrod F, Haworth L; Dash-Sodium Collaborative Research Group. Food group sources of nutrients in the dietary patterns of the DASH-Sodium trial. J Am Diet Assoc. 2003 Apr;103(4):488-96. doi: 10.1053/jada.2003.50065.
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    PubMed Identifier
    12847067
    Citation
    Erlinger TP, Miller ER 3rd, Charleston J, Appel LJ. Inflammation modifies the effects of a reduced-fat low-cholesterol diet on lipids: results from the DASH-sodium trial. Circulation. 2003 Jul 15;108(2):150-4. doi: 10.1161/01.CIR.0000080288.30567.86. Epub 2003 Jul 7.
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    PubMed Identifier
    12756219
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    Akita S, Sacks FM, Svetkey LP, Conlin PR, Kimura G; DASH-Sodium Trial Collaborative Research Group. Effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the pressure-natriuresis relationship. Hypertension. 2003 Jul;42(1):8-13. doi: 10.1161/01.HYP.0000074668.08704.6E. Epub 2003 May 19.
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    Citation
    Harsha DW, Sacks FM, Obarzanek E, Svetkey LP, Lin PH, Bray GA, Aickin M, Conlin PR, Miller ER 3rd, Appel LJ. Effect of dietary sodium intake on blood lipids: results from the DASH-sodium trial. Hypertension. 2004 Feb;43(2):393-8. doi: 10.1161/01.HYP.0000113046.83819.a2. Epub 2004 Jan 5.
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    Most MM, Craddick S, Crawford S, Redican S, Rhodes D, Rukenbrod F, Laws R; Dash-Sodium Collaborative Research Group. Dietary quality assurance processes of the DASH-Sodium controlled diet study. J Am Diet Assoc. 2003 Oct;103(10):1339-46. doi: 10.1016/s0002-8223(03)01080-0.
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    Juraschek SP, Kovell LC, Appel LJ, Miller ER 3rd, Sacks FM, Chang AR, Christenson RH, Rebuck H, Mukamal KJ. Effects of Diet and Sodium Reduction on Cardiac Injury, Strain, and Inflammation: The DASH-Sodium Trial. J Am Coll Cardiol. 2021 Jun 1;77(21):2625-2634. doi: 10.1016/j.jacc.2021.03.320.
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    PubMed Identifier
    34001808
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    Chaudhary P, Velkoska E, Wainford RD. An exploratory analysis of comparative plasma metabolomic and lipidomic profiling in salt-sensitive and salt-resistant individuals from The Dietary Approaches to Stop Hypertension Sodium Trial. J Hypertens. 2021 Oct 1;39(10):1972-1981. doi: 10.1097/HJH.0000000000002904.
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    33300290
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    Kim H, Lichtenstein AH, Wong KE, Appel LJ, Coresh J, Rebholz CM. Urine Metabolites Associated with the Dietary Approaches to Stop Hypertension (DASH) Diet: Results from the DASH-Sodium Trial. Mol Nutr Food Res. 2021 Feb;65(3):e2000695. doi: 10.1002/mnfr.202000695. Epub 2020 Dec 28.
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    derived
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    Juraschek SP, Miller ER 3rd, Chang AR, Anderson CAM, Hall JE, Appel LJ. Effects of Sodium Reduction on Energy, Metabolism, Weight, Thirst, and Urine Volume: Results From the DASH (Dietary Approaches to Stop Hypertension)-Sodium Trial. Hypertension. 2020 Mar;75(3):723-729. doi: 10.1161/HYPERTENSIONAHA.119.13932. Epub 2020 Jan 20.
    Results Reference
    derived
    PubMed Identifier
    31206400
    Citation
    Peng AW, Juraschek SP, Appel LJ, Miller ER 3rd, Mueller NT. Effects of the DASH Diet and Sodium Intake on Bloating: Results From the DASH-Sodium Trial. Am J Gastroenterol. 2019 Jul;114(7):1109-1115. doi: 10.14309/ajg.0000000000000283.
    Results Reference
    derived
    PubMed Identifier
    30690866
    Citation
    Peng AW, Appel LJ, Mueller NT, Tang O, Miller ER 3rd, Juraschek SP. Effects of sodium intake on postural lightheadedness: Results from the DASH-sodium trial. J Clin Hypertens (Greenwich). 2019 Mar;21(3):355-362. doi: 10.1111/jch.13487. Epub 2019 Jan 28.
    Results Reference
    derived
    PubMed Identifier
    29141784
    Citation
    Juraschek SP, Miller ER 3rd, Weaver CM, Appel LJ. Effects of Sodium Reduction and the DASH Diet in Relation to Baseline Blood Pressure. J Am Coll Cardiol. 2017 Dec 12;70(23):2841-2848. doi: 10.1016/j.jacc.2017.10.011. Epub 2017 Nov 12.
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    PubMed Identifier
    28993451
    Citation
    Juraschek SP, Woodward M, Sacks FM, Carey VJ, Miller ER 3rd, Appel LJ. Time Course of Change in Blood Pressure From Sodium Reduction and the DASH Diet. Hypertension. 2017 Nov;70(5):923-929. doi: 10.1161/HYPERTENSIONAHA.117.10017.
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    28855223
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    Derkach A, Sampson J, Joseph J, Playdon MC, Stolzenberg-Solomon RZ. Effects of dietary sodium on metabolites: the Dietary Approaches to Stop Hypertension (DASH)-Sodium Feeding Study. Am J Clin Nutr. 2017 Oct;106(4):1131-1141. doi: 10.3945/ajcn.116.150136. Epub 2017 Aug 30.
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    PubMed Identifier
    27938853
    Citation
    Juraschek SP, Choi HK, Tang O, Appel LJ, Miller ER 3rd. Opposing effects of sodium intake on uric acid and blood pressure and their causal implication. J Am Soc Hypertens. 2016 Dec;10(12):939-946.e2. doi: 10.1016/j.jash.2016.10.012. Epub 2016 Nov 11.
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    PubMed Identifier
    27523583
    Citation
    Juraschek SP, Gelber AC, Choi HK, Appel LJ, Miller ER 3rd. Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet and Sodium Intake on Serum Uric Acid. Arthritis Rheumatol. 2016 Dec;68(12):3002-3009. doi: 10.1002/art.39813.
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    PubMed Identifier
    25500372
    Citation
    Amer M, Woodward M, Appel LJ. Effects of dietary sodium and the DASH diet on the occurrence of headaches: results from randomised multicentre DASH-Sodium clinical trial. BMJ Open. 2014 Dec 11;4(12):e006671. doi: 10.1136/bmjopen-2014-006671.
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    derived
    PubMed Identifier
    20519561
    Citation
    Sun B, Williams JS, Svetkey LP, Kolatkar NS, Conlin PR. Beta2-adrenergic receptor genotype affects the renin-angiotensin-aldosterone system response to the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. Am J Clin Nutr. 2010 Aug;92(2):444-9. doi: 10.3945/ajcn.2009.28924. Epub 2010 Jun 2.
    Results Reference
    derived

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    Dietary Patterns, Sodium Intake and Blood Pressure (DASH - Sodium)

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