NCT02993458

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2017

Completed
Last Updated

December 8, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

December 12, 2016

Last Update Submit

December 6, 2017

Conditions

Blood High Pressure

Keywords

dietary patternsblood pressureadolescentsdietary sodium

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Diastolic blood pressure (DBP)

    End of 25 day feeding intervention

  • Total cholesterol

    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

  • +5 more secondary outcomes

Study Arms (4)

DASH diet-Low Na diet

EXPERIMENTAL

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

Other: DASH dietOther: Low Na diet

DASH diet-High Na diet

ACTIVE COMPARATOR

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

Other: DASH dietOther: High Na diet

Usual diet-Low Na diet

ACTIVE COMPARATOR

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

Other: Low Na dietOther: Usual Diet

Usual diet-High Na diet

ACTIVE COMPARATOR

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

Other: High Na dietOther: Usual Diet

Interventions

DASH dietOTHER

DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat

DASH diet-High Na dietDASH diet-Low Na diet
Low Na dietOTHER

Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.

DASH diet-Low Na dietUsual diet-Low Na diet
High Na dietOTHER

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.

DASH diet-High Na dietUsual diet-High Na diet
Usual DietOTHER

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.

Usual diet-High Na dietUsual diet-Low Na diet

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • White, black, Hispanic, and Asian
  • SBP in the upper one-third of the distribution for their given sex, age, and height

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics, IU School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Department of Nutrition Science, Purdue University

West Lafayette, Indiana, 47907-2059, United States

Location

Related Publications (12)

  • Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.

    PMID: 9099655BACKGROUND

  • Berenson GS, Srinivasan SR, Bao W, Newman WP 3rd, Tracy RE, Wattigney WA. Association between multiple cardiovascular risk factors and atherosclerosis in children and young adults. The Bogalusa Heart Study. N Engl J Med. 1998 Jun 4;338(23):1650-6. doi: 10.1056/NEJM199806043382302.

    PMID: 9614255BACKGROUND

  • Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.

    PMID: 18559702BACKGROUND

  • Couch SC, Saelens BE, Levin L, Dart K, Falciglia G, Daniels SR. The efficacy of a clinic-based behavioral nutrition intervention emphasizing a DASH-type diet for adolescents with elevated blood pressure. J Pediatr. 2008 Apr;152(4):494-501. doi: 10.1016/j.jpeds.2007.09.022. Epub 2007 Nov 5.

    PMID: 18346503BACKGROUND

  • Food and Nutrition Board, Institute of Medicine. 'Sodium and chloride', Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Washington, D.C.: National Academies Press; 2005. 269-423.

    BACKGROUND

  • Palacios C, Wigertz K, Martin BR, Braun M, Pratt JH, Peacock M, Weaver CM. Racial differences in potassium homeostasis in response to differences in dietary sodium in girls. Am J Clin Nutr. 2010 Mar;91(3):597-603. doi: 10.3945/ajcn.2009.28400. Epub 2009 Dec 9.

    PMID: 20007307BACKGROUND

  • Palacios C, Wigertz K, Braun M, Martin BR, McCabe GP, McCabe L, Pratt JH, Peacock M, Weaver CM. Magnesium retention from metabolic-balance studies in female adolescents: impact of race, dietary salt, and calcium. Am J Clin Nutr. 2013 May;97(5):1014-9. doi: 10.3945/ajcn.112.039867. Epub 2013 Apr 3.

    PMID: 23553157BACKGROUND

  • Palacios C, Wigertz K, Martin BR, Jackman L, Pratt JH, Peacock M, McCabe G, Weaver CM. Sodium retention in black and white female adolescents in response to salt intake. J Clin Endocrinol Metab. 2004 Apr;89(4):1858-63. doi: 10.1210/jc.2003-031446.

    PMID: 15070956BACKGROUND

  • Rakova N, Juttner K, Dahlmann A, Schroder A, Linz P, Kopp C, Rauh M, Goller U, Beck L, Agureev A, Vassilieva G, Lenkova L, Johannes B, Wabel P, Moissl U, Vienken J, Gerzer R, Eckardt KU, Muller DN, Kirsch K, Morukov B, Luft FC, Titze J. Long-term space flight simulation reveals infradian rhythmicity in human Na(+) balance. Cell Metab. 2013 Jan 8;17(1):125-31. doi: 10.1016/j.cmet.2012.11.013.

    PMID: 23312287BACKGROUND

  • Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.

    PMID: 11136953BACKGROUND

  • Van Horn L, Obarzanek E, Barton BA, Stevens VJ, Kwiterovich PO Jr, Lasser NL, Robson AM, Franklin FA Jr, Lauer RM, Kimm SY, Dorgan JF, Greenlick MR. A summary of results of the Dietary Intervention Study in Children (DISC): lessons learned. Prog Cardiovasc Nurs. 2003 Winter;18(1):28-41. doi: 10.1111/j.0889-7204.2003.01007.x.

    PMID: 12624570BACKGROUND

  • Weaver CM, Martin BR, McCabe GP, McCabe LD, Woodward M, Anderson CA, Appel LJ. Individual variation in urinary sodium excretion among adolescent girls on a fixed intake. J Hypertens. 2016 Jul;34(7):1290-7. doi: 10.1097/HJH.0000000000000960.

    PMID: 27176144BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Dietary Approaches To Stop Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Connie M Weaver, PhD

    Department of Nutrition Science, Purdue University

    PRINCIPAL INVESTIGATOR

  • Berdine R Martin, PhD

    Department of Nutrition Science, Purdue University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 15, 2016

Study Start

October 1, 2016

Primary Completion

October 18, 2017

Study Completion

October 18, 2017

Last Updated

December 8, 2017

Record last verified: 2017-12

Locations

US(2)