AzTrials
AzTrials

Dietary ModificationNCT03403166

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

An observational study of Dietary Modification and Blood Pressure, run by Johns Hopkins Bloomberg School of Public Health.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 22 to 100 years
Conditions the study is for
Dietary Modification, Blood Pressure
What is being tested?
DASH diet and Fruits and vegetables diet
How many people
459 participants
Where
No sites listed yet
Study dates
Aug 1993to Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

About this study

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

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.

Read the 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).

Being tested
DASH diet, Fruits and vegetables diet, Control diet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DASH dietBehavioural

    Diet intervention

  • Fruits and vegetables dietBehavioural

    Diet intervention

  • Control dietBehavioural

    Diet intervention

Study groups in NCT03403166
Study groupRoleWhat they receive
DASH dietThe 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.
Receives: Behavioral: DASH diet
Fruits and vegetables dietPotassium 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.
Receives: Behavioral: Fruits and vegetables diet
Control dietFor 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.
Receives: Behavioral: Control diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 8 week follow-up visit

Secondary outcomes (1)

  1. 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.

    Measured: 8 week follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2018
  2. Study startAug 1993
  3. Primary completionJul 1997
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
459 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403166
Sponsor's protocol ID
IRB00007383-2
Other IDs
K01DK107782
Status last verified
Jan 2018
First submitted
21 Dec 2017
Last updated
18 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 9099655

  • 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.

    PubMed 41143495

  • 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.

    PubMed 39196693

  • 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.

    PubMed 37161796

  • 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.

    PubMed 36974735

  • 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.

    PubMed 29917038

Questions about this trial

What is this clinical trial studying?

An observational study of Dietary Modification and Blood Pressure, run by Johns Hopkins Bloomberg School of Public Health.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum metabolites (time frame: 8 week follow-up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403166, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in