Clinical trial NCT02993458: DASH-Sodium Trial in Adolescents
Official title: DASH-Sodium Trial in Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood High Pressure
Keywords: dietary patterns
blood pressure
adolescents
dietary sodium
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Johns Hopkins University
name: Indiana University School of Medicine
name: University of California, San Diego
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-15
Enrollment: 79
Sex: ALL
Minimum age (years): 11
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Mean systolic blood pressure (SBP)
timeFrame: End of 25 day feeding intervention
measure: Non-HDL Cholesterol (HDLC)
timeFrame: End of 25 day feeding intervention
Secondary outcomes:
measure: Diastolic blood pressure (DBP)
timeFrame: End of 25 day feeding intervention
measure: Total cholesterol
timeFrame: End of 25 day feeding intervention
measure: HDL-cholesterol
timeFrame: End of 25 day feeding intervention
measure: LDL-cholesterol
timeFrame: End of 25 day feeding intervention
measure: Cholesterol:HDLC ratio
timeFrame: End of 25 day feeding intervention
measure: Triglycerides
timeFrame: End of 25 day feeding intervention
measure: Urinary mineral excretion
timeFrame: End of 25 day feeding intervention
measure: Regulators of sodium metabolism
timeFrame: End of 25 day feeding intervention
measure: Augmentation index
timeFrame: End of 25 day feeding intervention
measure: Vasoreactivity
timeFrame: End of 25 day feeding intervention
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Department of Pediatrics, IU School of Medicine
state: Indiana
city: West Lafayette
country: United States
facility: Department of Nutrition Science, Purdue University
state: Indiana
Study officials:
affiliation: Department of Nutrition Science, Purdue University
name: Connie M Weaver, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nutrition Science, Purdue University
name: Berdine R Martin, PhD
role: STUDY_DIRECTOR
References:
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citation: Palacios C, Wigertz K, Martin BR, Braun M, Pratt JH, Peacock M, Weaver CM. Racial differences in potassium homeostasis in response to differences in dietary sodium in girls. Am J Clin Nutr. 2010 Mar;91(3):597-603. doi: 10.3945/ajcn.2009.28400. Epub 2009 Dec 9.
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