Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern

NCT ID: NCT03403166

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

459 participants

Study Classification

OBSERVATIONAL

Study Start Date

1993-08-31

Study Completion Date

2017-06-30

Brief Summary

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The present record represents a secondary data analysis of the Dietary Approaches to Stop Hypertension (DASH) trial. Study data and specimens were accessed through the National Heart, Lung, and Blood Institute (NHLBI) Biologic Specimen and Data Repository Coordinating Center (BioLINCC). A global, untargeted, metabolomic profile was used to investigate biomarkers of the DASH dietary pattern as well as blood pressure change.

Detailed Description

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The present study was conducted in order to: 1) quantify the metabolomic expression of the DASH dietary pattern; and 2) examine the relationship between metabolites that reflect the DASH dietary pattern and blood pressure change. This secondary data analysis leverages the completed DASH trial, a randomized feeding trial (N=459).

Conditions

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Dietary Modification Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DASH diet

The DASH diet consisted of a high intake of fruits, vegetables, and low-fat dairy products. It included a wide range of sources of protein, such as meat, fish, poultry, nuts, and beans. Sugar-sweetened beverages, desserts, and red meat were restricted. In terms of nutrients, the DASH diet had a high amount of fiber and protein; low amounts of saturated fat, total fat, and cholesterol; and intake of potassium, magnesium, and calcium at levels close to the 75th percentile of U.S. consumption.

DASH diet

Intervention Type BEHAVIORAL

Diet intervention

Fruits and vegetables diet

Potassium and magnesium intake was similar to the 75th percentile of U.S. consumption. Fiber intake was high. The fruits and vegetables diet consisted of more fruits and vegetables and fewer snacks and desserts than the control diet, but otherwise was similar to the control diet.

Fruits and vegetables diet

Intervention Type BEHAVIORAL

Diet intervention

Control diet

For the control diet, macronutrient intake was similar to average U.S. consumption and intake of potassium, magnesium, and calcium were similar to the 25th percentile of U.S. consumption. Sodium intake was approximately 3 g/day in each diet.

Control diet

Intervention Type BEHAVIORAL

Diet intervention

Interventions

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DASH diet

Diet intervention

Intervention Type BEHAVIORAL

Fruits and vegetables diet

Diet intervention

Intervention Type BEHAVIORAL

Control diet

Diet intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and women with systolic blood pressure \<160 mmHg and diastolic blood pressure 80-95 mmHg

Exclusion Criteria

* Taking anti-hypertensive medication
* Poorly controlled diabetes mellitus
* Hyperlipidemia
* Cardiovascular event within the past 6 months
* Chronic disease that may interfere with participation
* Pregnancy or lactation
* Body mass index \> 35 kg/m2
* Unwilling to stop taking vitamin or mineral supplements or antacids
* Kidney disease
* Consumption of \>14 alcoholic beverages per week
* Did not consent to the use of biological specimens
* Did not attend the 8 week follow-up visit
* No serum specimen or insufficient volume of serum specimens in repository
Minimum Eligible Age

22 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Casey M. Rebholz, PhD, MS, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

References

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Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.

Reference Type RESULT
PMID: 9099655 (View on PubMed)

Kim H, Lichtenstein AH, Coresh J, Appel LJ, Rebholz CM. Serum proteins associated with LDL-C and non-HDL-C reduction in response to dietary interventions in the DASH and DASH-Sodium trials. Food Funct. 2025 Oct 27. doi: 10.1039/d5fo02593a. Online ahead of print.

Reference Type DERIVED
PMID: 41143495 (View on PubMed)

Kim H, Lichtenstein AH, Coresh J, Appel LJ, Rebholz CM. Serum protein responses to Dietary Approaches to Stop Hypertension (DASH) and DASH-Sodium trials and associations with blood pressure changes. J Hypertens. 2024 Oct 1;42(10):1823-1830. doi: 10.1097/HJH.0000000000003828. Epub 2024 Aug 1.

Reference Type DERIVED
PMID: 39196693 (View on PubMed)

Kim H, Appel LJ, Lichtenstein AH, Wong KE, Chatterjee N, Rhee EP, Rebholz CM. Metabolomic Profiles Associated With Blood Pressure Reduction in Response to the DASH and DASH-Sodium Dietary Interventions. Hypertension. 2023 Jul;80(7):1494-1506. doi: 10.1161/HYPERTENSIONAHA.123.20901. Epub 2023 May 10.

Reference Type DERIVED
PMID: 37161796 (View on PubMed)

Kim H, Lichtenstein AH, Ganz P, Du S, Tang O, Yu B, Chatterjee N, Appel LJ, Coresh J, Rebholz CM. Identification of Protein Biomarkers of the Dietary Approaches to Stop Hypertension Diet in Randomized Feeding Studies and Validation in an Observational Study. J Am Heart Assoc. 2023 Apr 4;12(7):e028821. doi: 10.1161/JAHA.122.028821. Epub 2023 Mar 28.

Reference Type DERIVED
PMID: 36974735 (View on PubMed)

Rebholz CM, Lichtenstein AH, Zheng Z, Appel LJ, Coresh J. Serum untargeted metabolomic profile of the Dietary Approaches to Stop Hypertension (DASH) dietary pattern. Am J Clin Nutr. 2018 Aug 1;108(2):243-255. doi: 10.1093/ajcn/nqy099.

Reference Type DERIVED
PMID: 29917038 (View on PubMed)

Other Identifiers

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K01DK107782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00007383-2

Identifier Type: -

Identifier Source: org_study_id

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