title: Cocoa, hazelnuts, sterols and soluble fiber cream reduces lipids and inflammation biomarkers in hypertensive patients: a randomized controlled trial.
abstract: BACKGROUND
  Cocoa, mixed with other food ingredients, intake can have beneficial effects on cardiovascular disease (CVD) biomarkers. We compared the effects of 4 cocoa cream products on some of these biomarkers.
  
  
  RESULTS
  In this multi-centered, randomized, controlled, double-blind, parallel trial, volunteers (n = 113; age range: 43-65 years) who were pre-hypertensive, stage-1 hypertensive and hypercholesterolemic received one of 4 cocoa cream products (13 g/unit; 1 g cocoa/unit, 6 units/d; 465 Kcal/d) added to a low saturated fat diet for 4 weeks. The groups were: A) (n = 28), cocoa cream considered as control; B) (n = 28), cocoa+hazelnut cream (30 g/d hazelnuts); C) (n = 30), cocoa+hazelnuts+phytosterols (2 g/d); and D) (n = 27), cocoa+hazelnuts+phytosterols+soluble fiber (20 g/d) the patented "LMN product". Primary outcome measures were BP, LDL-c, apolipoprotein B-100 (Apo B), ApoB/ApoA ratio, oxidized LDL (oxLDL) and high-sensitive C-reactive protein (hsCRP) determined at baseline and post-cocoa cream product intake. Statistical analysis used was ANCOVA or mixed models (in case of repeated measurements), with baseline observation included as a covariate. After 4 weeks, compared to product A, product C reduced LDL-c by 11.2%, Apo B by 8.1% and ApoB/ApoA ratio by 7.8% (P = 0.01). LMN decreased LDL-c by 9.2%, Apo B-100 by 8.5%, ApoB/ApoA ratio by 10.5%, hsCRP by 33.4% and oxLDL by 5.9% (P = 0.01). Surprisingly, even "control" product A reduced systolic BP (-7.89 mmHg; 95%CI: -11.45 to -4.3) and diastolic BP (-5.54 mmHg; 95%CI: -7.79 to -3.29). The BP reductions were similar with the other 3 products. Limitations of the study are that the trial period was relatively short and that a better "BP control" product would have been preferable.
  
  
  CONCLUSIONS
  The creams (particularly the LMN) have anti-inflammatory and antioxidant effects in addition to lowering LDL-c, Apo B and ApoB/ApoA ratio. Thus, the soluble fiber effects amplified with sterols (as contained in the cocoa creams) provide new dietary therapeutic perspectives.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00511420.
authors.affiliation: Unitat de Recerca en Lípids i Arteriosclerosi, CIBERDEM, Hospital Universitari Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, Reus, Spain. rosa.sola@urv.cat
authors.forename: Rosa
authors.initials: R
authors.lastname: Solà
authors.forename: Rosa M
authors.initials: RM
authors.lastname: Valls
authors.forename: Gemma
authors.initials: G
authors.lastname: Godàs
authors.forename: Gloria
authors.initials: G
authors.lastname: Perez-Busquets
authors.forename: Josep
authors.initials: J
authors.lastname: Ribalta
authors.forename: Josefa
authors.initials: J
authors.lastname: Girona
authors.forename: Mercedes
authors.initials: M
authors.lastname: Heras
authors.forename: Anna
authors.initials: A
authors.lastname: Cabré
authors.forename: Antoni
authors.initials: A
authors.lastname: Castro
authors.forename: Gema
authors.initials: G
authors.lastname: Domenech
authors.forename: Ferran
authors.initials: F
authors.lastname: Torres
authors.forename: Lluís
authors.initials: L
authors.lastname: Masana
authors.forename: Neus
authors.initials: N
authors.lastname: Anglés
authors.forename: Jordi
authors.initials: J
authors.lastname: Reguant
authors.forename: Bartolomé
authors.initials: B
authors.lastname: Ramírez
authors.forename: Joaquim M
authors.initials: JM
authors.lastname: Barriach
mesh_terms: D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000378:metabolism*; D002099:Cacao / Q000378:metabolism*; D002318:Cardiovascular Diseases / Q000188:drug therapy; D031211:Corylus / Q000378:metabolism*; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007249:Inflammation / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D012107:Research Design; D018401:Sample Size; D013261:Sterols / Q000737:chemistry*
chemical_list: D015415:Biomarkers; D008055:Lipids; D013261:Sterols