Trials / Completed
CompletedNCT01694056
Soy Protein Intake and the Metabolic Syndrome
Soy Protein Intake and the Metabolic Syndrome: Reducing Inflammation to Improve Insulin Resistance and Glucose Homeostasis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Wageningen University · Academic / Other
- Sex
- Female
- Age
- 45 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Soy protein diet | 4 weeks high protein diet (20 en%) with 25gr of soy protein per day |
| OTHER | Control diet | 4 weeks high mixed protein diet (20 en%) |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2012-09-26
- Last updated
- 2013-01-04
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01694056. Inclusion in this directory is not an endorsement.