Metabolic Syndrome X Clinical Trial
Official title:
Soy Protein Intake and the Metabolic Syndrome: Reducing Inflammation to Improve Insulin Resistance and Glucose Homeostasis
Soy protein has a high biological value, and contains several potential health-related nutritional factors, i.e. its amino acids pattern, biological active peptides and non-protein compounds such as isoflavones. In the field of obesity and blood lipids soy protein is well-studied and appreciated; it improves circulating blood lipids and is associated with weight reduction. The effect of soy on insulin resistance, glucose homeostasis and the metabolic syndrome is less frequently studied. However, several molecular mechanisms of action of soy protein make it a promising approach.
Objective: The primary objective of the present study is to evaluate the effect of a high
soy protein diet on insulin resistance and glycemic control in participants with
characteristics of the metabolic syndrome. Secondly, the present study will evaluate whether
reduced low-grade inflammation is a possible mechanism underlying the improvement in insulin
resistance and glucose homeostasis. Finally, it will be assessed whether soy protein has
beneficial effects on components of the metabolic syndrome, such as cardio-metabolic risk
factors, blood lipid profile, blood pressure and endothelial function, fat storage in the
liver and gene-expression in subcutaneous abdominal adipose tissue.
Study design: Single-blind, cross-over strictly-controlled dietary intervention.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
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