Clinical trial NCT03627637: Soy and Brain Vascular Function
Official title: The Effects of Soy on Brain Vascular Function in Elderly Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Vascular Function
Cerebral Blood Flow
Glucose Metabolism
Cognitive Performance
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Alpro Foundation
First posted: 2018-08-13
Enrollment: 23
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.


Eligibility 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)

Primary outcomes:
measure: Brain vascular function
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Secondary outcomes:
measure: Glucose metabolism
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Cognitive performance
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Other outcomes:
measure: Other physiological parameters: Peripheral vascular function (1)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Peripheral vascular function (2)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Peripheral vascular function (3)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Peripheral vascular function (4)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Peripheral vascular function (5)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Blood pressure
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Continuous blood glucose
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Advanced glycation endproducts
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Conventional metabolic risk markers (1)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Conventional metabolic risk markers (2)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Conventional metabolic risk markers (3)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Conventional metabolic risk markers (4)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Conventional metabolic risk markers (5)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Other parameters (1)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Other parameters (2)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other physiological parameters: Parameters for compliance
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Quality of Life
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Sleep characteristics
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Mood
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Physical fitness (1)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Physical fitness (2)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Physical fitness (3)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
measure: Other perceivable benefits: Physical fitness (4)
timeFrame: Difference between outcomes at the end of a 16-week soy nut intervention and control period.
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Peter J Joris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.