DASH-Sodium Trial in Adolescents (CampDASH)

Purdue University

Status: Terminated

Conditions: Blood High Pressure

Treatments: Other: DASH diet; Other: High Na diet; Other: Usual Diet; Other: Low Na diet

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT02993458

1U01HL128834-01A1

1U01HL128834 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 11 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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79 participants in 4 patient groups

DASH diet-Low Na diet

Experimental group

Description:

DASH style diet, low sodium (1500 mg/d).

Treatment:

Other: Low Na diet

Other: DASH diet

DASH diet-High Na diet

Active Comparator group

Description:

DASH style diet, high sodium (3500 mg/d).

Treatment:

Other: High Na diet

Other: DASH diet

Usual diet-Low Na diet

Active Comparator group

Description:

Diet reflecting typical dietary pattern of American adolescents, low sodium (1500 mg/d).

Treatment:

Other: Low Na diet

Other: Usual Diet

Usual diet-High Na diet

Active Comparator group

Description:

Diet reflecting typical dietary pattern of American adolescents, high sodium (3500 mg/d).

Treatment:

Other: High Na diet

Other: Usual Diet