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Soy and Brain Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627637
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Alpro Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Brain Vascular Function Cerebral Blood Flow Glucose Metabolism Cognitive Performance Dietary Supplement: Soy nuts Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will receive, in random order, daily 70 g of soy nuts (soy treatment) or no food products (control treatment) for sixteen weeks, separated by a wash-out period of at least 8 weeks.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Soy on Brain Vascular Function in Elderly Men and Women
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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)

  15. 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)

  16. 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)

  17. 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

  18. 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

  19. 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

  20. 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)

  21. 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)

  22. 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

  23. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627637


Locations
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Netherlands
Maastricht University Medical Center
Maastricht, Limburg, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
Alpro Foundation
Investigators
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Principal Investigator: Peter J Joris, PhD Maastricht University Medical Center
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03627637    
Other Study ID Numbers: METC183017
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No