Soy and Brain Vascular Function

January 15, 2020 updated by: Maastricht University Medical Center

The Effects of Soy on Brain Vascular Function in Elderly Men and Women

Cognitive performance is negatively related to an impaired glucose metabolism, possibly due to impairments in brain vascular function. Supported by the statement from the American Heart and American Stroke Association that healthy plant-based diets, which consist of soy foods, protect against cognitive decline, we now hypothesize that soy-induced changes in glucose metabolism cause beneficial effects on brain vascular function thereby improving cognitive performance. The primary objective of this intervention study is thus to evaluate in elderly men and women the effect of a 16-week soy intervention on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to examine effects on glucose metabolism using the oral glucose tolerance test and cognitive performance as assessed with a neurophysiological test battery.

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.

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.
23

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
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 ER
        • Maastricht University Medical Center

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

60 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged between 60-70 years
  • BMI between 20-30 kg/m2
  • Fasting plasma glucose < 7.0 mmol/L
  • Fasting serum total cholesterol < 8.0 mmol/L
  • Fasting serum triacylglycerol < 4.5 mmol/L
  • Systolic blood pressure < 160 mmHg and diastolic blood pressure < 100 mmHg
  • Stable body weight (weight gain or loss < 3 kg in the past three months)
  • Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
  • No difficult venipuncture as evidenced during the screening visit

Exclusion Criteria:

  • Allergy or intolerance to soy
  • Current smoker, or smoking cessation < 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • Use of soy products or dietary supplements known to interfere with the main outcomes as judged by the principal investigators
  • Use medication to treat blood pressure, lipid or glucose metabolism
  • Use of an investigational product within another biomedical intervention trial within the previous 1-month
  • Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
  • Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident
  • Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)

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: DOUBLE

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: Experimental: Soy nuts
Dietary supplement: Soy nuts
Study volunteers will receive daily 70 g of soy nuts (roasted soybeans containing approximately 100 mg isoflavones). The amount of soy protein provided by the nuts equals the FDA recommended daily intake of 25-30 g.
NO_INTERVENTION: Control - no soy nuts

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
Brain vascular function
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.

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
Glucose metabolism
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Oral Glucose Tolerance Test (OGTT)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Cognitive performance
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Other physiological parameters: Peripheral vascular function (1)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Flow-mediated vasodilation (FMD)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Peripheral vascular function (2)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Carotid artery reactivity (CAR)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Peripheral vascular function (3)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Pulse wave analysis (PWA)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Peripheral vascular function (4)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
pulse wave velocity (PWV)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Peripheral vascular function (5)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Retinal images
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Blood pressure
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Office and 24-hour ambulatory blood pressure
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Continuous blood glucose
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
36-hour glycaemic response
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Advanced glycation endproducts
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Serum protein-bound advanced glycation endproducts (AGEs)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Conventional metabolic risk markers (1)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Lipids and Lipoproteins
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Conventional metabolic risk markers (2)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Glucose
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Conventional metabolic risk markers (3)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Insulin
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Conventional metabolic risk markers (4)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Markers for low-grade systemic inflammation
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Conventional metabolic risk markers (5)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Markers for microvascular function
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Other parameters (1)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Brain-derived neurotrophic factor (blood)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Other parameters (2)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Cortisol levels (saliva)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other physiological parameters: Parameters for compliance
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Isoflavone levels (urine and blood)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Quality of Life
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
The Quality of life (QoL) will be assessed using a 32-item questionnaire
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Sleep characteristics
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Mood
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Mood will be tested using the Affect Grid
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Physical fitness (1)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Timed up-and-go test (TUGT)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Physical fitness (2)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
The 6-minute walk test (6 MWT)
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Physical fitness (3)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Handgrip test
Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other perceivable benefits: Physical fitness (4)
Time Frame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Muscle strength test
Difference between outcomes at the end of a 16-week soy nut intervention and control period.

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.
Maastricht University Medical Center

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

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 (ACTUAL)

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.
August 15, 2018

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 31, 2019

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 31, 2019

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).
July 24, 2018

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.
August 10, 2018

First Posted (ACTUAL)

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.
August 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

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 18, 2020

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 15, 2020

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, 2020

More Information

Terms related to this study

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.
  • METC183017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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