Soy and Brain Vascular Function

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03627637
• Collaborator: Alpro Foundation (Other)
• Enrollment: 23
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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.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: Aug 15, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Brain vascular function [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 [Difference between outcomes at the end of a 16-week soy nut intervention and control period.]

   Oral Glucose Tolerance Test (OGTT)

2. Cognitive performance [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) [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) [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) [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) [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) [Difference between outcomes at the end of a 16-week soy nut intervention and control period.]

   Retinal images

6. Other physiological parameters: Blood pressure [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 [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 [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) [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) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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) [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) [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) [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) [Difference between outcomes at the end of a 16-week soy nut intervention and control period.]

    Muscle strength test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht	Limburg	Netherlands	6229 ER

Sponsors and Collaborators

• Maastricht University Medical Center
• Alpro Foundation

Investigators

• Principal Investigator: Peter J Joris, PhD, Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT03627637
• Other Study ID Numbers: METC183017
• First Posted: Aug 13, 2018
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

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

Study Results

No Results Posted as of Jan 18, 2020