Back to resultsSoy Protein Intake and the Metabolic Syndrome (SOY)
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Soy protein diet
Control diet
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome X
Eligibility Criteria
Inclusion Criteria:
- Women
- 45-70 years
- No menstrual cycle for ≥1 year
- Stable body weight for ≥6 months (no weight gain/loss > 3 kg)
- Stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
- Central obesity: waist circumference ≥80 cm
Plus any one of the following four factors:
- Raised triglyceride level: ≥1.7 mmol/L;
- Reduced high-density lipoprotein (HDL) cholesterol: <1.29 mmol/L
- Raised blood pressure: systolic blood pressure ≥135 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication
- Raised fasting plasma glucose ≥ 5.6 mmol/L
Exclusion Criteria:
- (Undiagnosed) Diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening
- Active hearth disease, i.e. history of myocardial infarction, stroke or angina pectoris
- Active or a history of thyroid disease
- Cancer or other malignancies in the past 5 years
- Two sided ovariectomy
- Drug use knowing to interfere with objectives of the study
- oral corticosteroids, lipid-lowering drugs (statins)
- anti-conceptive use (such as the pill or IUD)
- hormone replacement therapy
- long-term antibiotics use
- Habitual intake of soy foods (>1 soy food per week)
- Isoflavone supplements
- Vegetarian
- Following, or have recently followed a (weight-loss) diet
- Allergic to soy or dairy products
- Smoking
- Consuming more than 14 glasses of alcohol per week
- Donated or intended to donate blood 2 months before till two months after the study
- Participation in another biomedical study within 1 month before the first screening visit
- Not willing to be informed if deviations are found in blood samples
- Contraindications to MRI scanning
Sites / Locations
- Wageningen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Soy protein diet
Control diet
Arm Description
High mixed protein diet (20 en%) with 25gr of soy protein per day
High mixed protein diet (20 en%)
Outcomes
Primary Outcome Measures
Insulin sensitivity
Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).
Secondary Outcome Measures
Adipose tissue gene expression
Adipose tissue samples will be collected for subsequent gene expression analysis.
Blood lipids
Circulating triglycerides, free fatty acids (FFA), and HDL and total cholesterol will be measured in fasted blood samples, LDL will be calculated.
Inflammation markers and adipokines
For low-grade inflammation interleukins, tumor necrosis factor-α, C-reactive protein and adipokines will be measured in fasting blood samples. Furthermore, peripheral blood mononuclear cells (PBMC's) will be collected to measure expression of genes involved in lipid handling and inflammation.
Cardio-metabolic risk factors
Blood pressure and macro vascular regional arterial stiffness will be assessed by Pulse Wave Analysis (PWA). Besides PWA, we will also measure markers for endothelial function in fasting blood samples.
Hepatic lipid content
Hepatic lipid content The lipid content in liver will be quantified by proton magnetic resonance spectroscopy (1H -MRS)
Full Information
NCT ID
NCT01694056
First Posted
September 4, 2012
Last Updated
January 3, 2013
Sponsor
Wageningen University
Collaborators
Alpro Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01694056
Brief Title
Soy Protein Intake and the Metabolic Syndrome
Acronym
SOY
Official Title
Soy Protein Intake and the Metabolic Syndrome: Reducing Inflammation to Improve Insulin Resistance and Glucose Homeostasis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University
Collaborators
Alpro Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Soy protein diet
Arm Type
Experimental
Arm Description
High mixed protein diet (20 en%) with 25gr of soy protein per day
Arm Title
Control diet
Arm Type
Active Comparator
Arm Description
High mixed protein diet (20 en%)
Intervention Type
Other
Intervention Name(s)
Soy protein diet
Intervention Description
4 weeks high protein diet (20 en%) with 25gr of soy protein per day
Intervention Type
Other
Intervention Name(s)
Control diet
Intervention Description
4 weeks high mixed protein diet (20 en%)
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adipose tissue gene expression
Description
Adipose tissue samples will be collected for subsequent gene expression analysis.
Time Frame
4 weeks
Title
Blood lipids
Description
Circulating triglycerides, free fatty acids (FFA), and HDL and total cholesterol will be measured in fasted blood samples, LDL will be calculated.
Time Frame
4 weeks
Title
Inflammation markers and adipokines
Description
For low-grade inflammation interleukins, tumor necrosis factor-α, C-reactive protein and adipokines will be measured in fasting blood samples. Furthermore, peripheral blood mononuclear cells (PBMC's) will be collected to measure expression of genes involved in lipid handling and inflammation.
Time Frame
4 weeks
Title
Cardio-metabolic risk factors
Description
Blood pressure and macro vascular regional arterial stiffness will be assessed by Pulse Wave Analysis (PWA). Besides PWA, we will also measure markers for endothelial function in fasting blood samples.
Time Frame
4 weeks
Title
Hepatic lipid content
Description
Hepatic lipid content The lipid content in liver will be quantified by proton magnetic resonance spectroscopy (1H -MRS)
Time Frame
4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women
45-70 years
No menstrual cycle for ≥1 year
Stable body weight for ≥6 months (no weight gain/loss > 3 kg)
Stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
Central obesity: waist circumference ≥80 cm
Plus any one of the following four factors:
Raised triglyceride level: ≥1.7 mmol/L;
Reduced high-density lipoprotein (HDL) cholesterol: <1.29 mmol/L
Raised blood pressure: systolic blood pressure ≥135 mmHg or diastolic BP ≥85 mmHg or use of blood pressure lowering medication
Raised fasting plasma glucose ≥ 5.6 mmol/L
Exclusion Criteria:
(Undiagnosed) Diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening
Active hearth disease, i.e. history of myocardial infarction, stroke or angina pectoris
Active or a history of thyroid disease
Cancer or other malignancies in the past 5 years
Two sided ovariectomy
Drug use knowing to interfere with objectives of the study
oral corticosteroids, lipid-lowering drugs (statins)
anti-conceptive use (such as the pill or IUD)
hormone replacement therapy
long-term antibiotics use
Habitual intake of soy foods (>1 soy food per week)
Isoflavone supplements
Vegetarian
Following, or have recently followed a (weight-loss) diet
Allergic to soy or dairy products
Smoking
Consuming more than 14 glasses of alcohol per week
Donated or intended to donate blood 2 months before till two months after the study
Participation in another biomedical study within 1 month before the first screening visit
Not willing to be informed if deviations are found in blood samples
Contraindications to MRI scanning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Mensink, PhD
Organizational Affiliation
Departement of Human Nutrition, Wageningen University
Official's Role
Study Chair
Facility Information:
Facility Name
Wageningen University
City
Wageningen
ZIP/Postal Code
6703 HD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
25008579
Citation
van Nielen M, Feskens EJ, Rietman A, Siebelink E, Mensink M. Partly replacing meat protein with soy protein alters insulin resistance and blood lipids in postmenopausal women with abdominal obesity. J Nutr. 2014 Sep;144(9):1423-9. doi: 10.3945/jn.114.193706. Epub 2014 Jul 9.
Results Reference
derived
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Soy Protein Intake and the Metabolic Syndrome
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