title: Olestra is associated with slight reductions in serum carotenoids but does not markedly influence serum fat-soluble vitamin concentrations.
abstract: BACKGROUND
  The 1996 Food and Drug Administration approval of the fat substitute olestra (sucrose polyester) called for active postmarketing surveillance because preapproval studies showed that olestra may lower circulating concentrations of fat-soluble nutrients such as vitamins and carotenoids.
  
  
  OBJECTIVE
  The objective of the Olestra Post-Marketing Surveillance Study was to examine whether customary consumption of olestra-containing savory snacks was associated with changes in serum fat-soluble vitamin and carotenoid concentrations among free-living persons in geographically and ethnically distinct US cities.
  
  
  METHODS
  Adults (n = 2535) and their children aged 12-17 y (n = 272) in Baltimore, Minneapolis, and San Diego attended clinic visits during which data were collected on diet, savory snack consumption, lifestyle, and anthropometric indexes. Blood samples were drawn to assay carotenoids and vitamins A, D, E, and K. Data and blood samples were collected both before and after the nationwide introduction of olestra. General estimating equations were used in multivariate-adjusted models that examined olestra's association with the specified serum nutrients.
  
  
  RESULTS
  Compared with no intake, the top 2 tertiles of olestra use in adults were associated with circulating carotenoid concentrations that were modestly but significantly lower (4.3% to 22.4%). There were no significant associations of olestra with any serum nutrients among adolescents.
  
  
  CONCLUSIONS
  This active postmarketing surveillance study of a food additive suggests that small decreases in serum fat-soluble nutrients are attributable to olestra use. Although health outcomes were not measured here, it is unlikely that these small changes in nutrient measures would adversely affect health.
authors.affiliation: Cancer Prevention Program, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. mneuhous@fhcrc.org
authors.forename: Marian L
authors.initials: ML
authors.lastname: Neuhouser
authors.forename: Cheryl L
authors.initials: CL
authors.lastname: Rock
authors.forename: Alan R
authors.initials: AR
authors.lastname: Kristal
authors.forename: Ruth E
authors.initials: RE
authors.lastname: Patterson
authors.forename: Dianne
authors.initials: D
authors.lastname: Neumark-Sztainer
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Cheskin
authors.forename: Mark D
authors.initials: MD
authors.lastname: Thornquist
mesh_terms: D000293:Adolescent; D000328:Adult; D000886:Anthropometry; D002338:Carotenoids / Q000097:blood*; D002648:Child; D015331:Cohort Studies; D019358:Fat Substitutes / Q000009:adverse effects* / Q000627:therapeutic use; D005227:Fatty Acids / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008019:Life Style; D008297:Male; D009752:Nutritional Status; D009765:Obesity / Q000097:blood / Q000188:drug therapy; D011358:Product Surveillance, Postmarketing; D012995:Solubility; D013395:Sucrose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014801:Vitamin A / Q000097:blood; D014807:Vitamin D / Q000097:blood; D014810:Vitamin E / Q000097:blood; D014812:Vitamin K / Q000097:blood; D014815:Vitamins / Q000097:blood*
chemical_list: D019358:Fat Substitutes; D005227:Fatty Acids; D014815:Vitamins; D014801:Vitamin A; D014812:Vitamin K; D014807:Vitamin D; D014810:Vitamin E; D002338:Carotenoids; D013395:Sucrose; C013692:sucrose polyester