title: Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial.
abstract: BACKGROUND
  The US Food and Drug Administration (FDA) approved health claims for 2 dietary fibers, beta-glucan (0.75 g/serving) and psyllium (1.78 g/serving), on the assumption that 4 servings/d would reduce cardiovascular disease risk.
  
  
  OBJECTIVE
  We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease.
  
  
  METHODS
  Sixty-eight hyperlipidemic adults consumed a test (high-fiber) and a control low-fat (25% of energy), low-cholesterol (<150 mg/d) diet for 1 mo each in a randomized crossover study. The high-fiber diet included 4 servings/d of foods containing beta-glucan or psyllium that delivered 8 g/d more soluble fiber than did similar, unsupplemented foods in the control diet. Fasting blood samples and blood pressure readings were obtained at baseline and weeks 2 and 4, and the subjects' weight was monitored weekly.
  
  
  RESULTS
  Compared with the control diet, the high-fiber diet reduced total cholesterol (2.1 +/- 0.7%; P = 0.003), total:HDL cholesterol (2.9 +/- 0.8%; P = 0.001), LDL:HDL cholesterol (2.4 +/- 1.0%; P = 0.015), and apolipoprotein B:A-I (1.4 +/- 0.8%; P = 0.076). Applying the Framingham cardiovascular disease risk equation to the data confirmed a reduction in risk of 4.2 +/- 1.4% (P = 0.003). Small reductions in blood pressure were found after both diets. The subjects reported no significant differences in palatability or gastrointestinal symptoms between the diets.
  
  
  CONCLUSIONS
  The reduction in serum lipid risk factors for cardiovascular disease supports the FDA's approval of a health claim for a dietary fiber intake of 4 servings/d. Although relatively small in terms of patient treatment, the reduction in cardiovascular disease risk is likely to be significant on a population basis.
authors.affiliation: Clinical Nutrition and Risk Factor Modification Center, St Michael'sHospital, Toronto, Canada.cyril.kendall@utoronto.edu
authors.forename: David J A
authors.initials: DJ
authors.lastname: Jenkins
authors.forename: Cyril W C
authors.initials: CW
authors.lastname: Kendall
authors.forename: Vladimir
authors.initials: V
authors.lastname: Vuksan
authors.forename: Edward
authors.initials: E
authors.lastname: Vidgen
authors.forename: Tina
authors.initials: T
authors.lastname: Parker
authors.forename: Dorothea
authors.initials: D
authors.lastname: Faulkner
authors.forename: Christine C
authors.initials: CC
authors.lastname: Mehling
authors.forename: Marcella
authors.initials: M
authors.lastname: Garsetti
authors.forename: Giulio
authors.initials: G
authors.lastname: Testolin
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Cunnane
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Ryan
authors.forename: Paul N
authors.initials: PN
authors.lastname: Corey
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001053:Apolipoproteins / Q000097:blood; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000209:etiology*; D018592:Cross-Over Studies; D004043:Dietary Fiber / Q000008:administration & dosage* / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D005260:Female; D005936:Glucans / Q000008:administration & dosage* / Q000494:pharmacology; D006304:Health Status; D006801:Humans; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D011620:Psyllium / Q000008:administration & dosage* / Q000494:pharmacology; D018570:Risk Assessment; D012307:Risk Factors; D012995:Solubility
chemical_list: D001053:Apolipoproteins; D004043:Dietary Fiber; D005936:Glucans; D008055:Lipids; D011620:Psyllium