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CompletedNCT03403166Updated Jan 18, 2018

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

An observational study in Dietary Modification and Blood Pressure, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed. Open to participants aged 22 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
459
Ages
22 Years to 100 Years
Sex
All
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Study 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.

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).

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Conditions studied

  • Dietary Modification
  • Blood Pressure

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Who can participate

Ages eligible
22 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
459 participants (actual)
Patient registry
No

Groups and cohorts

  • DASH diet

    The 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.

    Behavioral: DASH diet

  • Fruits and vegetables diet

    Potassium 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.

    Behavioral: Fruits and vegetables diet

  • Control diet

    For 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.

    Behavioral: Control diet

Interventions

  • BehavioralDASH diet

    Diet intervention

  • BehavioralFruits and vegetables diet

    Diet intervention

  • BehavioralControl diet

    Diet intervention

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What researchers measure

Primary outcomes

  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).

    Time frame: 8 week follow-up visit

Secondary outcomes

  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.

    Time frame: 8 week follow-up visit

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗
  • 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 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03403166
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Aug 1993
Primary completion
Jul 1997
Completion
Jun 2017
Last update
Jan 18, 2018

Study contacts

Casey M. Rebholz, PhD, MS, MPH
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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