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
Verified date | January 2018 |
Source | Johns Hopkins Bloomberg School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Johns Hopkins Bloomberg School of Public Health | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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
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 |
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