Cardiovascular DiseasesNCT00005167
Diet Modification and Blood Pressure in Young People
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the effects of diet modification on blood pressure, blood cholesterol, and bone density in healthy young people. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1984to Dec 1991
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the effects of diet modification on blood pressure, blood cholesterol, and bone density in healthy young people.
Read the 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.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1984
- Study completionDec 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005167
- Sponsor's protocol ID
- 1041
- Other IDs
- R01HL032821
- Status last verified
- Apr 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
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.
PubMed 6475924Witschi 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.
PubMed 4008832Goldberg 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.
PubMed 3988380Goldberg 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.
PubMed 4034281Ellison RC, Cohn PF: Prevention of Coronary Atherosclerosis. In: Diagnosis and Therapy of Coronary Artery Disease, Second Edition. Boston, Martinus Nijoff, p 283-303, 1985
Capper AL, Witschi J: Schools in the Fire: How to Improve Children's Dietary Habits. Food Management, December, 1986
Ellison RC: Dangers of Screening for Hyperlipidemia in Children (Letter to the Editor). N Engl J Med, 314:1579-1580, 1986
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.
PubMed 3680823Capper AL, Doane DD: Can a Reduced Sodium Diet Prevent Hypertension? J Nat Assoc College Auxiliary Services, August:47-49, 1987
Korn L, Hosmer DW, Lemeshow S: The Performance of Goodness of Fit Tests for Logistic Regression With Discrete Covariates. Biometrical Journal (in press), 0000
Capper AL, Doane DD: Dining Hall Employees Contribute to Science. College Services Administration (in press), 0000
Ellison RC. Give diet a chance in lowering cholesterol levels. Arch Intern Med. 1988 May;148(5):1017-9. No abstract available.
PubMed 3365070Ellison 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.
PubMed 2732069Ellison 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.
PubMed 2709080Ellison 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.
PubMed 2240309
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Modification and Blood Pressure in Young People
- ClinicalTrials.gov ID
- NCT00005167
- Acronym / sponsor ID
- 1041
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1984
- Study completion
- Dec 1991 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 6475924Ellison 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.
- Background: PubMed 4008832Witschi 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.
- Background: PubMed 3988380Goldberg 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.
- Background: PubMed 4034281Goldberg 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.
- BackgroundEllison RC, Cohn PF: Prevention of Coronary Atherosclerosis. In: Diagnosis and Therapy of Coronary Artery Disease, Second Edition. Boston, Martinus Nijoff, p 283-303, 1985
- BackgroundCapper AL, Witschi J: Schools in the Fire: How to Improve Children's Dietary Habits. Food Management, December, 1986
- BackgroundEllison RC: Dangers of Screening for Hyperlipidemia in Children (Letter to the Editor). N Engl J Med, 314:1579-1580, 1986
- Background: PubMed 3680823Witschi 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.
- BackgroundCapper AL, Doane DD: Can a Reduced Sodium Diet Prevent Hypertension? J Nat Assoc College Auxiliary Services, August:47-49, 1987
- BackgroundKorn L, Hosmer DW, Lemeshow S: The Performance of Goodness of Fit Tests for Logistic Regression With Discrete Covariates. Biometrical Journal (in press), 0000
- BackgroundCapper AL, Doane DD: Dining Hall Employees Contribute to Science. College Services Administration (in press), 0000
- Background: PubMed 3365070Ellison RC. Give diet a chance in lowering cholesterol levels. Arch Intern Med. 1988 May;148(5):1017-9. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005167, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.