Evidence map›Paper›PMID 22383996›Full record

Trial reportPloS one2012

Cocoa, hazelnuts, sterols and soluble fiber cream reduces lipids and inflammation biomarkers in hypertensive patients: a randomized controlled trial.

Rosa Solà, Rosa M Valls, Gemma Godàs, Gloria Perez-Busquets, Josep Ribalta, Josefa Girona, Mercedes Heras, Anna Cabré, Antoni Castro, Gema Domenech and 6 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00511420 (Effects of Cocoa Products on Cardiovascular Disease Risk Factors), which is not on this map. Cited by 15 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 4 pooled it
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00511420 phase3completednot on this map

Effects of Cocoa Products on Cardiovascular Disease Risk Factors

TypeinterventionalSponsorUniversity Rovira i VirgiliRan2005 to 2005Enrolled113ConditionsCardiovascular DiseasesArmsCocoa product type 1, Cocoa product type 2, Cocoa product type 3, Cocoa product type 4
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 44 citations in OpenAlex.

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  15. Cardiovascular benefits of dietary fiber.Current atherosclerosis reports · 2012
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Rosa SolàUnitat de Recerca en Lípids i Arteriosclerosi, CIBERDEM, Hospital Universitari Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, Reus, Spain. rosa.sola@urv.cat
Rosa M Valls
Gemma Godàs
Gloria Perez-Busquets
Josep Ribalta
Josefa Girona
Mercedes Heras
Anna Cabré
Antoni Castro
Gema Domenech
Ferran Torres
Lluís Masana
Neus Anglés
Jordi Reguant
Bartolomé Ramírez
Joaquim M Barriach
Institut d'Investigació Sanitària Pere Virgili · ESHospital Universitari Sant Joan de Reus · ESUniversidad Rovira i Virgili · ESCentro de Investigación Biomédica en Red · ESConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCocoa, 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. METHODS AND

findingsIn 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.

conclusionThe 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.

trial registrationClinicaltrials.gov NCT00511420.

Indexed as

AdultAgedBiomarkersCacaoCardiovascular DiseasesCorylusDietDouble-Blind MethodFemaleHumansHypertensionInflammationLipidsMaleMiddle AgedResearch DesignBiomarkersLipidsSterols

Identifiers

PMID22383996
PMCPMC3287993
OpenAlexW2137595013

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.