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

Am J Clin Nutr. 2002 May;75(5):834-9. doi: 10.1093/ajcn/75.5.834.


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.

Design: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Apolipoproteins / blood
  • Blood Pressure / drug effects
  • Cardiovascular Diseases / etiology*
  • Cross-Over Studies
  • Dietary Fiber / administration & dosage*
  • Dietary Fiber / pharmacology
  • Dose-Response Relationship, Drug
  • Drug Approval*
  • Female
  • Glucans / administration & dosage*
  • Glucans / pharmacology
  • Health Status*
  • Humans
  • Lipids / blood*
  • Male
  • Middle Aged
  • Psyllium / administration & dosage*
  • Psyllium / pharmacology
  • Risk Assessment
  • Risk Factors
  • Solubility


  • Apolipoproteins
  • Dietary Fiber
  • Glucans
  • Lipids
  • Psyllium