Diet Modification and Blood Pressure in Young People
Primary Purpose
Cardiovascular Diseases, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005167
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
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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
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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
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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
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Citation
Capper AL, Witschi JC: Reduced Salt in School Food - Can it Work? J Nat Assoc College Food Services (in press), 0000
Results Reference
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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
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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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