- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00005233
Patterns of Fatty Acids in Framingham Offspring
Studieoversikt
Status
Detaljert beskrivelse
BACKGROUND:
In 1988, research suggested that high intake of saturated fat increased the risk of cardiovascular disease and cancer, and feeding polyunsaturated fatty acids decreased plasma lipid values. However, understanding of the roles of specific types of fatty acids in nutrition and health remained limited. This was primarily because the technology for analysis of fatty acid compositions in human tissue had only recently achieved the required specificities and secondarily because application of the technology on the large scale of an epidemiologic study had to await recent advances in automation of the chromatography. Also intervention studies, aimed at reducing dietary intake of polyunsaturated fatty acids for long periods of time, were either impractical or unethical. The study was conducted to confirm preliminary results suggesting greater prevalence of low levels of essential fatty acids, particularly w3 fatty acids, among people with cardiovascular disease and hypertension, and to provide further confirmatory evidence to results that hyperlipidemia was inversely associated with essential fatty acid levels.
DESIGN NARRATIVE:
Subjects were randomly selected from existing lists so that six men and six women were selected from each age-year group from 30 to 69 broken down as follows: ages 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69. Plasma samples for these subjects were retrieved from storage in batches and analyzed. The prevailing distribution of fatty acids in the general population was calculated. The interrelationships were studied among levels of fatty acids, particularly w3 and w6 fatty acids, with lipoproteins and apolipoproteins. Relationships among fatty acid compositions of different lipid fractions were explored and their relationship with various cardiovascular risk factors were evaluated. Over 60 fatty acids were quantitated using capillary gas-liquid chromatography. Tables of reference values were produced for the general population and for selected subpopulations. Multivariate analysis was used to correlate fatty acids and other biochemical markers.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Studietype
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Studieplan
Hvordan er studiet utformet?
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1113
- R01HL039681 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .