title: Can foods with added soya-protein or fish-oil reduce risk factors for coronary disease? A factorial randomised controlled trial.
abstract: OBJECTIVE
  To develop functional foods which are capable of reducing key risk factors for coronary heart disease in an at risk population. The specific hypothesis tested here was that providing bread, cracker biscuits and snack bars fortified with DHA (long-chain omega 3) and soya-protein would havd a positive impact on cholesterol and blood pressure.
  
  
  RESULTS
  A pragmatic, double-blind, factorial placebo-controlled randomised trial recruiting 213 middle-aged men and women with untreated elevated total cholesterol or blood pressure. The factors examined were the effect of giving supplies of bread, cereal bars and cracker biscuits fortified with 2 g fish oils (DHA, 22: 6n-3), or 25 g soya-protein (containing 50 mg of isoflavonoids) for five weeks. Primary and secondary outcomes included total, low-density and high-density cholesterol (HDL-C), and systolic and diastolic blood pressure. Compliance was assessed using biomarkers and food intake histories. DHA enriched foods increased HDL-C by 6.0% (95% CI 2.5%, 9.6%) but had no effect on total or low-density cholesterol or blood pressure. Overall, soya-protein did not influence any of the outcomes assessed. However, in women only, soya-protein increased systolic blood pressure by 5.9% (95% CI 1.73, 9.9%).
  
  
  CONCLUSIONS
  Adding DHA (fish-oils) to staple foods might supplement existing methods to help reduce CVD morbidity and mortality. However, these findings highlight the importance of ensuring that functional foods do not present any harms to particular subgroups within a general population, if they are to be made freely available to consumers. This latter point requires further attention by the research community in relation to soya-protein.
authors.affiliation: Bolton Primary Care Trust, UK.
authors.forename: R A
authors.initials: RA
authors.lastname: Harrison
authors.forename: M
authors.initials: M
authors.lastname: Sagara
authors.forename: A
authors.initials: A
authors.lastname: Rajpura
authors.forename: L
authors.initials: L
authors.lastname: Armitage
authors.forename: N
authors.initials: N
authors.lastname: Birt
authors.forename: C A
authors.initials: CA
authors.lastname: Birt
authors.forename: Y
authors.initials: Y
authors.lastname: Yamori
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D003327:Coronary Disease / Q000453:epidemiology* / Q000517:prevention & control; D004311:Double-Blind Method; D005163:Factor Analysis, Statistical; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage*; D058870:Food, Organic; D006801:Humans; D006937:Hypercholesterolemia / Q000178:diet therapy*; D006973:Hypertension / Q000178:diet therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D030262:Soybean Proteins / Q000008:administration & dosage*
chemical_list: D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D030262:Soybean Proteins; D002784:Cholesterol