Soy and Brain Vascular Function

NCT03627637 | Completed

• 1 other identifier: METC183017
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Vascular Function; Cerebral Blood Flow; Glucose Metabolism; Cognitive Performance

Outcome Measures

Primary Outcomes (1)

• Brain vascular function

  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 Outcomes (2)

• Glucose metabolism

  Difference between outcomes at the end of a 16-week soy nut intervention and control period.

• Cognitive performance

  Difference between outcomes at the end of a 16-week soy nut intervention and control period.

Other Outcomes (23)

• Other physiological parameters: Peripheral vascular function (1)

  Difference between outcomes at the end of a 16-week soy nut intervention and control period.

• Other physiological parameters: Peripheral vascular function (2)

  Difference between outcomes at the end of a 16-week soy nut intervention and control period.

• Other physiological parameters: Peripheral vascular function (3)

  Difference between outcomes at the end of a 16-week soy nut intervention and control period.

Study Arms (2)

Experimental: Soy nuts

EXPERIMENTAL

Dietary Supplement: Soy nuts

Control - no soy nuts

NO INTERVENTION

Interventions

Soy nuts DIETARY_SUPPLEMENT

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.

Experimental: Soy nuts

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Alpro Foundation: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 35395555 DERIVED

• 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.

  PMID: 34510189 DERIVED

Study Officials

• Peter J Joris, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 13, 2018
• Study Start: August 15, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

NL (1)