DASH-Sodium Trial in Adolescents
- Conditions
- Blood High Pressure
- Interventions
- Other: Low Na dietOther: DASH dietOther: High Na dietOther: Usual Diet
- Registration Number
- NCT02993458
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 79
- White, black, Hispanic, and Asian
- SBP in the upper one-third of the distribution for their given sex, age, and height
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual diet-Low Na diet Low Na diet Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d). DASH diet-High Na diet DASH diet DASH style diet, high sodium (3500 mg/d). DASH diet-High Na diet High Na diet DASH style diet, high sodium (3500 mg/d). DASH diet-Low Na diet Low Na diet DASH style diet, low sodium (1500 mg/d). DASH diet-Low Na diet DASH diet DASH style diet, low sodium (1500 mg/d). Usual diet-Low Na diet Usual Diet Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d). Usual diet-High Na diet High Na diet Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d). Usual diet-High Na diet Usual Diet Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
- Primary Outcome Measures
Name Time Method Mean systolic blood pressure (SBP) 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.
Non-HDL Cholesterol (HDLC) 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
Name Time Method Diastolic blood pressure (DBP) 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..
Total cholesterol 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.
HDL-cholesterol 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
LDL-cholesterol 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
Cholesterol:HDLC ratio 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.
Triglycerides 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
Urinary mineral excretion 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..
Regulators of sodium metabolism 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
Augmentation index 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.
Vasoreactivity 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.
Trial Locations
- Locations (2)
Department of Pediatrics, IU School of Medicine
🇺🇸Indianapolis, Indiana, United States
Department of Nutrition Science, Purdue University
🇺🇸West Lafayette, Indiana, United States