An interventional study of DASH diet and Low Na diet in Blood High Pressure, sponsored by Purdue University. Terminated at 2 sites in United States. Open to participants aged 11 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Purdue University · Not applicable, Interventional, and Prevention
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 79 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
DASH style diet, low sodium (1500 mg/d).
Other: DASH diet · Other: Low Na diet
DASH style diet, high sodium (3500 mg/d).
Other: DASH diet · Other: High Na diet
Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).
Other: Low Na diet · Other: Usual Diet
Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).
Other: High Na diet · Other: Usual Diet
DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat
Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.
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.
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.
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.
Time frame: 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
Time frame: End of 25 day feeding intervention
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..
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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..
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: End of 25 day feeding intervention
Plan to share: Undecided
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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