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Diet Modification and Blood Pressure in Young People

Primary Purpose

Cardiovascular Diseases, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005167
    Brief Title
    Diet Modification and Blood Pressure in Young People
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    April 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1984 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1991 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the effects of diet modification on blood pressure, blood cholesterol, and bone density in healthy young people.
    Detailed Description
    BACKGROUND: An inadequate dietary intake of calcium has been postulated to be a factor in the development of essential hypertension, and has long been considered important in the development of osteoporosis among women. Furthermore, animal experiments and limited studies in humans suggest that an increase in the intake of calcium may also have a beneficial effect on blood cholesterol levels. Despite limitations in the research data supporting its benefits, increased calcium intake is being widely advocated to the public and calcium-enriched products are being increasingly purchased and consumed by Americans. The study measured the effects of a modest increase in calcium intake, such as that currently advocated to the general public. Previous work in the study measured the effects on blood pressures of variations in the dietary intake of sodium and linoleic acid in adolescents at the two New England boarding schools of Phillips Exeter Academy and Phillips Andover Academy. During the first year, dining room food at one school was prepared with 50 percent less sodium; total intake of sodium by students including dining hall food, outside food and snacks was reduced by approximately 35 percent. The other school served as the control. During the second year, the intervention took place at the second school. During the third and fourth years, sodium intake was kept at usual levels while changes were made in food preparation to double the polyunsaturated fatty acid intake from four percent to eight percent of dietary calories. Food diaries, duplicate food samples, and 24-hour urine collections by approximately 200 students at each school were used to monitor dietary modification and student compliance. Weekly blood pressure measurements were performed on the 200 students at each school. DESIGN NARRATIVE: A number of food products were modified to increase the dietary intake of calcium by an average of 500 mg/day. Calcium-enriched foods were served alternately for one school year at each of two colleges. Similar products without added calcium were served during the alternate year. It was postulated that, at the end of the school year, students at the intervention school would have lower systolic blood pressure, lower blood cholesterol, and increased bone density than students at the control school. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    6475924
    Citation
    Ellison RC, Gamble WJ, Taft DS. A device for the automatic measurement of blood pressure in epidemiologic studies. Am J Epidemiol. 1984 Oct;120(4):542-9. doi: 10.1093/oxfordjournals.aje.a113915.
    Results Reference
    background
    PubMed Identifier
    4008832
    Citation
    Witschi JC, Ellison RC, Doane DD, Vorkink GL, Slack WV, Stare FJ. Dietary sodium reduction among students: feasibility and acceptance. J Am Diet Assoc. 1985 Jul;85(7):816-21.
    Results Reference
    background
    PubMed Identifier
    3988380
    Citation
    Goldberg RJ, Ellison RC, Dalen JE. Uses of the case-control and cohort epidemiological approaches in cardiology practice and research. Int J Cardiol. 1985 Apr;7(4):439-46. doi: 10.1016/0167-5273(85)90102-0. No abstract available.
    Results Reference
    background
    PubMed Identifier
    4034281
    Citation
    Goldberg RJ, Pastides H, Ellison RC, Tuthill RW, Dewitt T. Uses of the case-control and cohort epidemiological approaches in pediatric practice and research. Pediatr Res. 1985 Aug;19(8):787-90. doi: 10.1203/00006450-198508000-00001.
    Results Reference
    background
    Citation
    Ellison RC, Cohn PF: Prevention of Coronary Atherosclerosis. In: Diagnosis and Therapy of Coronary Artery Disease, Second Edition. Boston, Martinus Nijoff, p 283-303, 1985
    Results Reference
    background
    Citation
    Capper AL, Witschi J: Schools in the Fire: How to Improve Children's Dietary Habits. Food Management, December, 1986
    Results Reference
    background
    Citation
    Ellison RC: Dangers of Screening for Hyperlipidemia in Children (Letter to the Editor). N Engl J Med, 314:1579-1580, 1986
    Results Reference
    background
    PubMed Identifier
    3680823
    Citation
    Witschi JC, Capper AL, Hosmer DW Jr, Ellison RC. Sources of sodium, potassium, and energy in the diets of adolescents. J Am Diet Assoc. 1987 Dec;87(12):1651-5.
    Results Reference
    background
    Citation
    Capper AL, Doane DD: Can a Reduced Sodium Diet Prevent Hypertension? J Nat Assoc College Auxiliary Services, August:47-49, 1987
    Results Reference
    background
    Citation
    Korn L, Hosmer DW, Lemeshow S: The Performance of Goodness of Fit Tests for Logistic Regression With Discrete Covariates. Biometrical Journal (in press), 0000
    Results Reference
    background
    Citation
    Capper AL, Doane DD: Dining Hall Employees Contribute to Science. College Services Administration (in press), 0000
    Results Reference
    background
    PubMed Identifier
    3365070
    Citation
    Ellison RC. Give diet a chance in lowering cholesterol levels. Arch Intern Med. 1988 May;148(5):1017-9. No abstract available.
    Results Reference
    background
    PubMed Identifier
    2732069
    Citation
    Ellison RC, Capper AL, Goldberg RJ, Witschi JC, Stare FJ. The environmental component: changing school food service to promote cardiovascular health. Health Educ Q. 1989 Summer;16(2):285-97. doi: 10.1177/109019818901600211.
    Results Reference
    background
    PubMed Identifier
    2709080
    Citation
    Ellison RC, Capper AL, Stephenson WP, Goldberg RJ, Hosmer DW Jr, Humphrey KF, Ockene JK, Gamble WJ, Witschi JC, Stare FJ. Effects on blood pressure of a decrease in sodium use in institutional food preparation: the Exeter-Andover Project. J Clin Epidemiol. 1989;42(3):201-8. doi: 10.1016/0895-4356(89)90056-5.
    Results Reference
    background
    PubMed Identifier
    2240309
    Citation
    Ellison RC, Goldberg RJ, Witschi JC, Capper AL, Puleo EM, Stare FJ. Use of fat-modified food products to change dietary fat intake of young people. Am J Public Health. 1990 Nov;80(11):1374-6. doi: 10.2105/ajph.80.11.1374.
    Results Reference
    background
    Citation
    Capper AL, Witschi JC: Reduced Salt in School Food - Can it Work? J Nat Assoc College Food Services (in press), 0000
    Results Reference
    background
    PubMed Identifier
    1609765
    Citation
    Goldberg RJ, Ellison RC, Hosmer DW Jr, Capper AL, Puleo E, Gamble WJ, Witschi J. Effects of alterations in fatty acid intake on the blood pressure of adolescents: the Exeter-Andover Project. Am J Clin Nutr. 1992 Jul;56(1):71-6. doi: 10.1093/ajcn/56.1.71.
    Results Reference
    background
    PubMed Identifier
    2212428
    Citation
    Witschi JC, Capper AL, Ellison RC. Sources of fat, fatty acids, and cholesterol in the diets of adolescents. J Am Diet Assoc. 1990 Oct;90(10):1429-31. No abstract available.
    Results Reference
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    Diet Modification and Blood Pressure in Young People

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