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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403166
• Other study ID #: IRB00007383-2
• Secondary ID: K01DK107782
• Status: Completed
• Phase: N/A
• First received: December 21, 2017
• Last updated: January 17, 2018
• Start date: August 1993
• Est. completion date: June 2017

Study information

• Verified date: January 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: June 2017
• Est. primary completion date: July 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Dietary Modification
• Hypertension

Intervention

Behavioral:
• DASH diet
Diet intervention
• Fruits and vegetables diet
Diet intervention
• Control diet
Diet intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure	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.	8 week follow-up visit