European Journal of Nutrition

, Volume 57, Issue 2, pp 499–511 | Cite as

Effect of soy on metabolic syndrome and cardiovascular risk factors: a randomized controlled trial

  • Massimiliano RuscicaEmail author
  • Chiara Pavanello
  • Sara Gandini
  • Monica Gomaraschi
  • Cecilia Vitali
  • Chiara Macchi
  • Beatrice Morlotti
  • Gilda Aiello
  • Raffaella Bosisio
  • Laura Calabresi
  • Anna Arnoldi
  • Cesare R. Sirtori
  • Paolo MagniEmail author
Original Contribution



Cardiovascular diseases are currently the commonest cause of death worldwide. Different strategies for their primary prevention have been planned, taking into account the main known risk factors, which include an atherogenic lipid profile and visceral fat excess.


The study was designed as a randomized, parallel, single-center study with a nutritional intervention duration of 12 weeks. Whole soy foods corresponding to 30 g/day soy protein were given in substitution of animal foods containing the same protein amount.


Soy nutritional intervention resulted in a reduction in the number of MetS features in 13/26 subjects. Moreover, in the soy group we observed a significant improvement of median percentage changes for body weight (−1.5 %) and BMI (−1.5 %), as well as for atherogenic lipid markers, namely TC (−4.85 %), LDL-C (−5.25 %), non-HDL-C (−7.14 %) and apoB (−14.8 %). Since the majority of the studied variables were strongly correlated, three factors were identified which explained the majority (52 %) of the total variance in the whole data set. Among them, factor 1, which loaded lipid and adipose variables, explained the 22 % of total variance, showing a statistically significant difference between treatment arms (p = 0.002).


The inclusion of whole soy foods (corresponding to 30 g/day protein) in a lipid-lowering diet significantly improved a relevant set of biomarkers associated with cardiovascular risk.


Soy protein Lipids Metabolic syndrome and obesity 



Apolipoprotein B


Apolipoprotein A-I


Body mass index


Bioelectrical impedance analysis


High-sensitivity C-reactive protein


Cardiovascular diseases


Diastolic blood pressure


Fasting plasma glucose


Hip circumference


High-density lipoprotein cholesterol


Homeostatic model assessment


Heart rate


Low-density lipoprotein cholesterol


Lipoprotein (a)




Proprotein convertase subtilisin/kexin 9


Systolic blood pressure


Soluble intercellular adhesion molecular 1


Total cholesterol




Visceral fat rating


Waist circumference



This study has been supported by an unrestricted grant to Centro Dislipidemie (A.S.S.T. Grande Ospedale Metropolitano Niguarda, Milano, Italy) from the Alpro Foundation (Gent, Belgium). The founding sponsors had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; and in the decision to publish the results.

Author contributions

MR wrote the paper and performed ELISA experiments; PM wrote the paper and coordinated the study; AA, LC and CS conceived the study and critically revised the manuscript; CP selected the patients and acted as clinical monitor; SG performed all the statistical analyses; BM and CM performed biochemical analysis; MG and CV performed analysis on HDL; GA performed isoflavones analysis; and RB was the dietician. All authors reviewed the results and approved the final version of the manuscript.

Compliance with ethical standards

Conflict of interest

The authors declare no conflict of interest.

Supplementary material

394_2016_1333_MOESM1_ESM.docx (178 kb)
Supplementary material 1 (DOCX 177 kb)


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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Massimiliano Ruscica
    • 1
    Email author
  • Chiara Pavanello
    • 2
  • Sara Gandini
    • 3
  • Monica Gomaraschi
    • 2
  • Cecilia Vitali
    • 2
  • Chiara Macchi
    • 1
  • Beatrice Morlotti
    • 4
  • Gilda Aiello
    • 5
  • Raffaella Bosisio
    • 4
  • Laura Calabresi
    • 2
  • Anna Arnoldi
    • 5
  • Cesare R. Sirtori
    • 4
  • Paolo Magni
    • 2
    Email author
  1. 1.Dipartimento di Scienze Farmacologiche e BiomolecolariUniversità degli Studi di MilanoMilanItaly
  2. 2.Centro Grossi Paoletti, Dipartimento di Scienze Farmacologiche e BiomolecolariUniversità degli Studi di MilanoMilanItaly
  3. 3.Division of Epidemiology and BiostatisticsEuropean Institute of OncologyMilanItaly
  4. 4.Centro DislipidemieA.S.S.T. Grande Ospedale Metropolitano NiguardaMilanItaly
  5. 5.Dipartimento di Scienze FarmaceuticheUniversità degli Studi di MilanoMilanItaly

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