Metabolic Syndrome XSOYNCT01694056
Soy Protein Intake and the Metabolic Syndrome
A study testing Soy protein diet in people with Metabolic Syndrome X, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Soy protein diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- (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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Metabolic Syndrome X
- Being tested
- Soy protein diet, Control diet
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy protein dietOther
4 weeks high protein diet (20 en%) with 25gr of soy protein per day
Control dietOther
4 weeks high mixed protein diet (20 en%)
| Study group | Role | What they receive |
|---|---|---|
| Soy protein diet | Experimental | High mixed protein diet (20 en%) with 25gr of soy protein per day Receives: Other: Soy protein diet |
| Control diet | Active comparator | High mixed protein diet (20 en%) Receives: Other: Control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).
Measured: 4 weeks
Secondary outcomes (5)
Adipose tissue gene expression
Adipose tissue samples will be collected for subsequent gene expression analysis.
Measured: 4 weeks
Blood lipids
Circulating triglycerides, free fatty acids (FFA), and HDL and total cholesterol will be measured in fasted blood samples, LDL will be calculated.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Hepatic lipid content
Hepatic lipid content The lipid content in liver will be quantified by proton magnetic resonance spectroscopy (1H -MRS)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Alpro Foundation
- Responsible party
- Sponsor
- Investigators
- Marco Mensink, PhD, Study chair, Departement of Human Nutrition, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694056
- Sponsor's protocol ID
- NL39991.081.12
- Acronym
- SOY
- Status last verified
- Jan 2013
- First submitted
- 4 Sep 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25008579
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Protein Intake and the Metabolic Syndrome: Reducing Inflammation to Improve Insulin Resistance and Glucose Homeostasis
- ClinicalTrials.gov ID
- NCT01694056
- Acronym / sponsor ID
- SOY / NL39991.081.12
- Conditions
- Metabolic Syndrome X
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Alpro Foundation
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy protein diet | Experimental | Other: Soy protein dietHigh mixed protein diet (20 en%) with 25gr of soy protein per day |
| Control diet | Active comparator | Other: Control dietHigh mixed protein diet (20 en%) |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy protein diet4 weeks high protein diet (20 en%) with 25gr of soy protein per day | Other | Soy protein diet |
| Control diet4 weeks high mixed protein diet (20 en%) | Other | Control diet |
Primary outcome
Insulin sensitivity
Time frame: 4 weeks
Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).
5 secondary outcomes
Adipose tissue gene expression
Time frame: 4 weeks
Blood lipids
Time frame: 4 weeks
Inflammation markers and adipokines
Time frame: 4 weeks
Cardio-metabolic risk factors
Time frame: 4 weeks
Hepatic lipid content
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Derived from this study: PubMed 25008579van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Mensink, PhD study chair
Departement of Human Nutrition, Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein diet in people with Metabolic Syndrome X, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01694056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.