Clinical trial NCT03403166: Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern
Official title: Metabolomics of the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern: A Secondary Data Analysis of the DASH Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dietary Modification
Blood Pressure
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-01-18
Enrollment: 459
Sex: ALL
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Serum metabolites
timeFrame: 8 week follow-up visit
Secondary outcomes:
measure: Blood pressure
timeFrame: 8 week follow-up visit
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Casey M. Rebholz, PhD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.