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DASH-Sodium Trial in Adolescents (CampDASH)

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ClinicalTrials.gov Identifier: NCT02993458
Recruitment Status : Terminated (safety risks to youth in the study required early termination of the study)
First Posted : December 15, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Johns Hopkins University
Indiana University School of Medicine
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Berdine Martin, Purdue University

Brief Summary:
The Camp DASH study trial will compare the effect of two dietary patterns and two levels of sodium intake on blood pressure and blood lipids in adolescents in the upper third of distribution for blood pressure. The two dietary patterns are based on the Dietary Approaches to Stop Hypertension (DASH) trial in adults.

Condition or disease Intervention/treatment Phase
Blood High Pressure Other: DASH diet Other: Low Na diet Other: High Na diet Other: Usual Diet Not Applicable

Detailed Description:
The Camp DASH study is a controlled trial. the aim of which is to compare the effect of two dietary patterns and two levels of sodium intake on blood pressure and blood lipids in adolescents in the upper third of distribution for blood pressure. The study also assesses whether influences on blood pressure and blood lipids of dietary interventions vary according to sex, race/ethnic groups, baseline levels, and other personal characteristics. The proposed dietary interventions of DASH dietary patterns and sodium reduction have been shown to be effective in lowering blood pressure in adults. The two dietary patterns are based on the Dietary Approaches to Stop Hypertension (DASH) trial in adults. They are a Usual diet typical of what many American adolescents eat, and a DASH-type diet. The DASH diet is rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat compared to the Usual diet. The two sodium levels are High reflecting current US consumption and Low reflecting current recommended intake levels. Weight will be held constant by adjusting energy intake. The study participants will live in a residence hall on the Purdue campus where all food and beverages will be provided, and meals and snacks will be supervised.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: DASH-Sodium Trial in Adolescents
Study Start Date : October 2016
Actual Primary Completion Date : October 18, 2017
Actual Study Completion Date : October 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DASH diet-Low Na diet
DASH style diet, low sodium (1500 mg/d).
Other: DASH diet
DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat

Other: 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.

Active Comparator: DASH diet-High Na diet
DASH style diet, high sodium (3500 mg/d).
Other: DASH diet
DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat

Other: 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.

Active Comparator: Usual diet-Low Na diet
Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).
Other: 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.

Other: 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.

Active Comparator: Usual diet-High Na diet
Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
Other: 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.

Other: 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.




Primary Outcome Measures :
  1. Mean systolic blood pressure (SBP) [ Time Frame: End of 25 day feeding intervention ]
    The primary outcome is mean SBP at the end of each intervention feeding period. Mean end of intervention SBP is the average of daily readings during days 19-25 of each intervention feeding period. Blood pressure will also be measured periodically at baseline and throughout the study.

  2. Non-HDL Cholesterol (HDLC) [ Time Frame: End of 25 day feeding intervention ]
    Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period


Secondary Outcome Measures :
  1. Diastolic blood pressure (DBP) [ Time Frame: End of 25 day feeding intervention ]
    The secondary outcome is mean DBP at the end of each intervention feeding period. Mean end of intervention DBP is the average of daily readings during days 19-25 of each intervention feeding period. Blood pressure will also be measured periodically at baseline and throughout the study..

  2. Total cholesterol [ Time Frame: End of 25 day feeding intervention ]
    Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period.

  3. HDL-cholesterol [ Time Frame: End of 25 day feeding intervention ]
    Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period

  4. LDL-cholesterol [ Time Frame: End of 25 day feeding intervention ]
    Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period

  5. Cholesterol:HDLC ratio [ Time Frame: End of 25 day feeding intervention ]
    Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period.

  6. Triglycerides [ Time Frame: End of 25 day feeding intervention ]
    Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period

  7. Urinary mineral excretion [ Time Frame: End of 25 day feeding intervention ]
    Two 24-hr urine samples at the end of the feeding periods will be analyzed for sodium, potassium, magnesium, and calcium..

  8. Regulators of sodium metabolism [ Time Frame: End of 25 day feeding intervention ]
    Regulators of sodium homeostasis (renin, aldosterone, angiotensin) will be measured at the beginning and end of the feeding period

  9. Augmentation index [ Time Frame: End of 25 day feeding intervention ]
    Pulse wave analysis (At Cor Medical) will be used to measure changes in augmentation index (AI) with intervention to index central blood pressure.

  10. Vasoreactivity [ Time Frame: End of 25 day feeding intervention ]
    Skin flow motion (laser-doppler flowmetry) to measure diet-induced changes in vaso-reactivity will provide mechanistic information on microvascular control.



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Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • White, black, Hispanic, and Asian
  • SBP in the upper one-third of the distribution for their given sex, age, and height

Exclusion Criteria:

  • Pre-existing lipid disorders, abnormal liver or kidney function
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993458


Locations
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United States, Indiana
Department of Pediatrics, IU School of Medicine
Indianapolis, Indiana, United States, 46202
Department of Nutrition Science, Purdue University
West Lafayette, Indiana, United States, 47907-2059
Sponsors and Collaborators
Purdue University
Centers for Disease Control and Prevention
Johns Hopkins University
Indiana University School of Medicine
University of California, San Diego
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Connie M Weaver, PhD Department of Nutrition Science, Purdue University
Study Director: Berdine R Martin, PhD Department of Nutrition Science, Purdue University
Publications:
Food and Nutrition Board, Institute of Medicine. 'Sodium and chloride', Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington, D.C.: National Academies Press; 2005. 269-423.

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Responsible Party: Berdine Martin, Senior Research Scientist, Purdue University
ClinicalTrials.gov Identifier: NCT02993458    
Other Study ID Numbers: 1U01HL128834-01A1 ( U.S. NIH Grant/Contract )
1U01HL128834 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Berdine Martin, Purdue University:
dietary patterns
blood pressure
adolescents
dietary sodium
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases