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| Name | Class |
|---|---|
| Alpro Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Soy nuts | Experimental |
| |
| Control - no soy nuts | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose metabolism | Oral Glucose Tolerance Test (OGTT) | Difference between outcomes at the end of a 16-week soy nut intervention and control period. |
| Cognitive performance | Cambridge Neuropsychological Test Automated Battery (CANTAB) |
| Measure | Description | Time Frame |
|---|---|---|
| Other physiological parameters: Peripheral vascular function (1) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Joris, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229 ER | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35395555 | Derived | 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. | |
| 34510189 | Derived |
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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.
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| 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) | 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) | 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) | Retinal images | Difference between outcomes at the end of a 16-week soy nut intervention and control period. |
| Other physiological parameters: Blood pressure | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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) | 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) | 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) | Handgrip test | Difference between outcomes at the end of a 16-week soy nut intervention and control period. |
| Other perceivable benefits: Physical fitness (4) | Muscle strength test | Difference between outcomes at the end of a 16-week soy nut intervention and control period. |
| 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. |