DASH-Sodium Trial in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 79
- 试验地点
- 4
- 主要终点
- Mean systolic blood pressure (SBP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •White, black, Hispanic, and Asian
- •SBP in the upper one-third of the distribution for their given sex, age, and height
排除标准
- •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
研究组 & 干预措施
DASH diet-Low Na diet
DASH style diet, low sodium (1500 mg/d).
干预措施: DASH diet (Other)
DASH diet-Low Na diet
DASH style diet, low sodium (1500 mg/d).
干预措施: Low Na diet (Other)
DASH diet-High Na diet
DASH style diet, high sodium (3500 mg/d).
干预措施: DASH diet (Other)
DASH diet-High Na diet
DASH style diet, high sodium (3500 mg/d).
干预措施: High Na diet (Other)
Usual diet-Low Na diet
Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).
干预措施: Low Na diet (Other)
Usual diet-Low Na diet
Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).
干预措施: Usual Diet (Other)
Usual diet-High Na diet
Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
干预措施: High Na diet (Other)
Usual diet-High Na diet
Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
干预措施: Usual Diet (Other)
结局指标
主要结局
Mean systolic blood pressure (SBP)
时间窗: 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)
时间窗: 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
次要结局
- Total cholesterol(End of 25 day feeding intervention)
- Diastolic blood pressure (DBP)(End of 25 day feeding intervention)
- HDL-cholesterol(End of 25 day feeding intervention)
- LDL-cholesterol(End of 25 day feeding intervention)
- Cholesterol:HDLC ratio(End of 25 day feeding intervention)
- Triglycerides(End of 25 day feeding intervention)
- Urinary mineral excretion(End of 25 day feeding intervention)
- Regulators of sodium metabolism(End of 25 day feeding intervention)
- Augmentation index(End of 25 day feeding intervention)
- Vasoreactivity(End of 25 day feeding intervention)
研究者
Berdine Martin
Senior Research Scientist
Purdue University