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

NCT03403166 | Completed

• 2 other identifiers: IRB00007383-2K01DK107782
• Study Type: observational
• Target: 459
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dietary Modification; Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Serum metabolites

  Metabolites were measured using a global, untargeted, metabolomic platform in serum specimens collected at the end of the 8 week diet intervention in the DASH trial. Reverse phase, untargeted ultrahigh-performance liquid chromatography tandem mass spectrometry quantification was used to measure metabolites. Peaks were quantified by calculating the area under the curve. Data were normalized to account for day-to-day instrumental variation. Compounds were identified by comparison to a library of purified standards or recurrent unknown entities and matches were determined based on retention time, mass-to-charge ratio, and chromatographic data. A relative measure of each metabolite (not absolute) is determined. The Metabolon (Durham, NC) platform quantifies over 1,000 compounds representing a broad range of metabolic compounds, including amino acids, carbohydrates, cofactors and vitamins, energy, lipids, nucleotides, peptides, and xenobiotics (chemicals, drugs, and food components).

  8 week follow-up visit

Secondary Outcomes (1)

• Blood pressure

  8 week follow-up visit

Study Arms (3)

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.

Behavioral: DASH diet

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.

Behavioral: Fruits and vegetables diet

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.

Behavioral: Control diet

Interventions

DASH diet BEHAVIORAL

Diet intervention

DASH diet

Fruits and vegetables diet BEHAVIORAL

Diet intervention

Fruits and vegetables diet

Control diet BEHAVIORAL

Diet intervention

Control diet

Eligibility Criteria

• Age: 22 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of men and women (aged 22 years and older) with systolic blood pressure \<160 mmHg and diastolic blood pressure 80-95 mmHg who were not taking antihypertensive medication. The mean age was 44 years, about half were women, and approximately 2/3 were black or another race/ethnicity minority. The mean body mass index was 28 kg/m2 and mean blood pressure was 132/82 mmHg.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (6)

• 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.

  PMID: 9099655 RESULT

• 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 Nov 10;16(22):8764-8772. doi: 10.1039/d5fo02593a.

  PMID: 41143495 DERIVED

• 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.

  PMID: 39196693 DERIVED

• 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.

  PMID: 37161796 DERIVED

• 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.

  PMID: 36974735 DERIVED

• 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.

  PMID: 29917038 DERIVED

MeSH Terms

Interventions

Dietary Approaches To Stop Hypertension; Fruit

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Food; Food and Beverages

Study Officials

• Casey M. Rebholz, PhD, MS, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 18, 2018
• Study Start: August 1, 1993
• Primary Completion: July 1, 1997
• Study Completion: June 1, 2017
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share