DASH-Sodium Trial in Adolescents

Study Overview
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Brief Summary
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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
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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.

Official Title
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DASH-Sodium Trial in Adolescents

Conditions
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Blood High Pressure

Intervention / Treatment
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* Other: DASH diet
* Other: Low Na diet
* Other: High Na diet
* Other: Usual Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DASH diet-Low Na diet<br>DASH style diet, low sodium (1500 mg/d). | Other: DASH diet<br>* DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat<br>Other: Low Na diet<br>* Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.<br>|
| Active Comparator: DASH diet-High Na diet<br>DASH style diet, high sodium (3500 mg/d). | Other: DASH diet<br>* DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat<br>Other: High Na diet<br>* 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.<br>|
| Active Comparator: Usual diet-Low Na diet<br>Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d). | Other: Low Na diet<br>* Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.<br>Other: Usual Diet<br>* 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.<br>|
| Active Comparator: Usual diet-High Na diet<br>Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d). | Other: High Na diet<br>* 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.<br>Other: Usual Diet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean systolic blood pressure (SBP) | 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. | End of 25 day feeding intervention | 
| Non-HDL Cholesterol (HDLC) | Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period | End of 25 day feeding intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic blood pressure (DBP) | 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.. | End of 25 day feeding intervention | 
| Total cholesterol | Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period. | End of 25 day feeding intervention | 
| HDL-cholesterol | Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period | End of 25 day feeding intervention | 
| LDL-cholesterol | Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period | End of 25 day feeding intervention | 
| Cholesterol:HDLC ratio | Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period. | End of 25 day feeding intervention | 
| Triglycerides | Fasting blood samples for lipids and other variables will be drawn at the beginning and end of each feeding period | End of 25 day feeding intervention | 
| Urinary mineral excretion | Two 24-hr urine samples at the end of the feeding periods will be analyzed for sodium, potassium, magnesium, and calcium.. | End of 25 day feeding intervention | 
| Regulators of sodium metabolism | Regulators of sodium homeostasis (renin, aldosterone, angiotensin) will be measured at the beginning and end of the feeding period | End of 25 day feeding intervention | 
| Augmentation index | Pulse wave analysis (At Cor Medical) will be used to measure changes in augmentation index (AI) with intervention to index central blood pressure. | End of 25 day feeding intervention | 
| Vasoreactivity | Skin flow motion (laser-doppler flowmetry) to measure diet-induced changes in vaso-reactivity will provide mechanistic information on microvascular control. | End of 25 day feeding intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary patterns, blood pressure, adolescents, dietary sodium