NCT01694056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

3 months

First QC Date

September 4, 2012

Last Update Submit

January 3, 2013

Conditions

Metabolic Syndrome X

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity is measured with an intravenous glucose tolerance test (IVGTT).

    4 weeks

Secondary Outcomes (5)

  • Adipose tissue gene expression

    4 weeks

  • Blood lipids

    4 weeks

  • Inflammation markers and adipokines

    4 weeks

  • Cardio-metabolic risk factors

    4 weeks

  • Hepatic lipid content

    4 weeks

Study Arms (2)

Soy protein diet

EXPERIMENTAL

High mixed protein diet (20 en%) with 25gr of soy protein per day

Other: Soy protein diet

Control diet

ACTIVE COMPARATOR

High mixed protein diet (20 en%)

Other: Control diet

Interventions

Soy protein dietOTHER

4 weeks high protein diet (20 en%) with 25gr of soy protein per day

Soy protein diet
Control dietOTHER

4 weeks high mixed protein diet (20 en%)

Control diet

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • 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

You may not qualify if:

  • (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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 6703 HD, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25008579DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marco Mensink, PhD

    Departement of Human Nutrition, Wageningen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 26, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

NL(1)