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Completed

NCT Number: NCT03403166

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

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.

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Key information

Conditions

Dietary Modification Blood Pressure

Age range

22 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DASH diet

Behavioral

Diet intervention

Fruits and vegetables diet

Behavioral

Diet intervention

Control diet

Behavioral

Diet intervention

Primary outcomes

  1. Serum metabolites

    Time frame: 8 week follow-up visit

    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).

Secondary outcomes

  1. Blood pressure

    Time frame: 8 week follow-up visit

    The change in blood pressure was defined as the blood pressure level at the end of the 8 week diet intervention minus the blood pressure level at baseline.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

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

Registry information

Official study title

Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern: A Secondary Data Analysis of the DASH Trial

Important dates

Study start
1993
Primary completion
1997
Study completion
2017
First posted
Jan 18, 2018
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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