Soy Protein Intake and the Metabolic Syndrome (SOY)

January 3, 2013 updated by: Wageningen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6703 HD
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Soy protein diet
High mixed protein diet (20 en%) with 25gr of soy protein per day
Other: Soy protein diet
4 weeks high protein diet (20 en%) with 25gr of soy protein per day
ACTIVE_COMPARATOR: Control diet
High mixed protein diet (20 en%)
Other: Control diet
4 weeks high mixed protein diet (20 en%)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Insulin sensitivity
Time Frame: 4 weeks
Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adipose tissue gene expression
Time Frame: 4 weeks
Adipose tissue samples will be collected for subsequent gene expression analysis.
4 weeks
Blood lipids
Time Frame: 4 weeks
Circulating triglycerides, free fatty acids (FFA), and HDL and total cholesterol will be measured in fasted blood samples, LDL will be calculated.
4 weeks
Inflammation markers and adipokines
Time Frame: 4 weeks
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.
4 weeks
Cardio-metabolic risk factors
Time Frame: 4 weeks
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.
4 weeks
Hepatic lipid content
Time Frame: 4 weeks
Hepatic lipid content The lipid content in liver will be quantified by proton magnetic resonance spectroscopy (1H -MRS)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wageningen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alpro Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marco Mensink, PhD, Departement of Human Nutrition, Wageningen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL39991.081.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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