- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627637
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
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental: 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
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
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
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.
Collaborators
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
- Tischmann L, Adam TC, Mensink RP, Joris PJ. Longer-term soy nut consumption improves vascular function and cardiometabolic risk markers in older adults: Results of a randomized, controlled cross-over trial. Clin Nutr. 2022 May;41(5):1052-1058. doi: 10.1016/j.clnu.2022.03.014. Epub 2022 Mar 14.
- Kleinloog JPD, Tischmann L, Mensink RP, Adam TC, Joris PJ. Longer-term soy nut consumption improves cerebral blood flow and psychomotor speed: results of a randomized, controlled crossover trial in older men and women. Am J Clin Nutr. 2021 Dec 1;114(6):2097-2106. doi: 10.1093/ajcn/nqab289.
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)
August 15, 2018
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
December 31, 2019
Study Registration Dates
First Submitted
July 24, 2018
First Submitted That Met QC Criteria
August 10, 2018
First Posted (ACTUAL)
August 13, 2018
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 15, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID 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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