Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
79 participants
INTERVENTIONAL
2016-10-31
2017-10-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DASH diet-Low Na diet
DASH style diet, low sodium (1500 mg/d).
DASH diet
DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat
Low Na diet
Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.
DASH diet-High Na diet
DASH style diet, high sodium (3500 mg/d).
DASH diet
DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat
High Na diet
Sodium intake of 3500 mg/d (152 mmol, or 1.73 mg/Kcal/d, representing the highest sodium intake used for adults in the DASH Sodium trial.
Usual diet-Low Na diet
Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).
Low Na diet
Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.
Usual Diet
The usual diet will include foods that provide the majority of energy for adolescents in the U.S., i.e. grain based desserts, pizza, sugary drinks,pasta, chicken, and chicken mixed dishes.
Usual diet-High Na diet
Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
High Na diet
Sodium intake of 3500 mg/d (152 mmol, or 1.73 mg/Kcal/d, representing the highest sodium intake used for adults in the DASH Sodium trial.
Usual Diet
The usual diet will include foods that provide the majority of energy for adolescents in the U.S., i.e. grain based desserts, pizza, sugary drinks,pasta, chicken, and chicken mixed dishes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DASH diet
DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat
Low Na diet
Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.
High Na diet
Sodium intake of 3500 mg/d (152 mmol, or 1.73 mg/Kcal/d, representing the highest sodium intake used for adults in the DASH Sodium trial.
Usual Diet
The usual diet will include foods that provide the majority of energy for adolescents in the U.S., i.e. grain based desserts, pizza, sugary drinks,pasta, chicken, and chicken mixed dishes.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* SBP in the upper one-third of the distribution for their given sex, age, and height
Exclusion Criteria
* Taking medications that alter mineral absorption or metabolism, affect blood pressure or lipids
* If subjects are taking dietary supplements and refuse to discontinue them 2 months prior to the study.
* Taking non-prescription illegal drugs, smoke, or drink alcohol
* Pregnancy
* Carry an epi pen for food-related allergies
11 Years
15 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centers for Disease Control and Prevention
FED
Johns Hopkins University
OTHER
Indiana University School of Medicine
OTHER
University of California, San Diego
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Purdue University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Berdine Martin
Senior Research Scientist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Connie M Weaver, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Nutrition Science, Purdue University
Berdine R Martin, PhD
Role: STUDY_DIRECTOR
Department of Nutrition Science, Purdue University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Pediatrics, IU School of Medicine
Indianapolis, Indiana, United States
Department of Nutrition Science, Purdue University
West Lafayette, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.