Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005468 |
| Other study ID # |
4913 |
| Secondary ID |
R01HL043041 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
May 12, 2016 |
| Start date |
July 1990 |
| Est. completion date |
December 1992 |
Study information
| Verified date |
June 2000 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
To investigate the variability of lipids and specifically the effects of stress on serum
triglyceride levels, total cholesterol, HDL, and LDL in a 2.5 year epidemiological study.
Description:
BACKGROUND:
While researchers had documented some of the behavioral contributors to fluctuation in
individuals' lipid levels (e.g., nutrition patterns, smoking, exercise), little attention
had been given to psychosocial stress. Early reports utilizing accountants, race car
drivers, and air traffic controllers provided some uncontrolled data associating stress with
cholesterol increases. Yet, no empirical research on stress that concomitantly examined
other related influences was available. This paucity of data was probably due to lack of
objective measures of stress and difficulty in measuring lipid subfractions.
DESIGN NARRATIVE:
Based on the results of their pilot study, and their research observations, the
investigators predicted significant positive associations between stress level and
triglycerides. A total of 228 public accountants (148 men and 80 women to provide comparable
power between the sexes) were recruited from the greater Birmingham, Alabama area.
Participants were evaluated monthly for 18 months, across three stressful and non-stressful
work intervals (i.e., tax seasons). The investigators also collected data (during this same
time frame) to closely monitor the following variables that affect lipids: dietary intake
(including alcohol, caffeine, total calories, total fat, saturated fat, and dietary
cholesterol), smoking, and physical activity, and oral contraceptive use, pregnancy status
and menstrual stage among the women. Additionally, a substudy presented a unique opportunity
for them to investigate the relation between stress and triglyceride-rich lipoproteins in
the formation of foam cells.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
