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Clinical Trials/NCT04210869
NCT04210869
Completed
Not Applicable

The Long-Term Effects of Mixed Nuts Consumption on Brain Vascular Function in Elderly Men and Women

Maastricht University Medical Center1 site in 1 country28 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Vascular Function
Sponsor
Maastricht University Medical Center
Enrollment
28
Locations
1
Primary Endpoint
Brain Vascular Function
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Impaired brain vascular function precedes the development of reduced cognitive performance, while brain insulin-resistance is also associated with cognitive decline. The Mediterranean diet, which is rich in nuts, may protect against the development of impaired cognitive performance. The hypothesis is that long-term mixed nut consumption increases brain insulin-sensitivity thereby improving brain vascular function and cognitive performance. The primary objective is to evaluate in elderly men and women the effect of 16-week mixed nut consumption on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labelling (ASL). Cerebral blood flow is a robust and sensitive physiological marker of brain vascular function. Secondary objectives are to investigate effects on the cerebral blood flow response to intranasal insulin delivery - a marker of insulin-sensitivity in the human brain - as quantified by ASL, and cognitive functioning as assessed with a neuropsychological test battery.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged between 60-70 years
  • BMI between 25-35 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 nuts
  • Left-handedness
  • Current smoker, or smoking cessation \< 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • More than 3 alcoholic consumptions per day
  • Use of 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

Outcomes

Primary Outcomes

Brain Vascular Function

Time Frame: Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.

Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

Secondary Outcomes

  • Brain Insulin Sensitivity(Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.)
  • Cognitive performance(Change in outcomes at the end of a 16-week mixed nuts intervention and 16-week control period.)

Study Sites (1)

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