- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005468
Lipid Variability--Influence of Stress
Study Overview
Status
Detailed 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.
Study Type
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Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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Other Study ID Numbers
- 4913
- R01HL043041 (U.S. NIH Grant/Contract)
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