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Lifestyle and Brain Vascular Function

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Terminated

Conditions

Cerebral Blood Flow
Healthy Lifestyle
Healthy Diet
Cognitive Performance
Glucose Metabolism
Cerebrovascular Circulation
Physical Exercise

Treatments

Other: Healthy Lifestyle

Study type

Interventional

Funder types

Other

Identifiers

NCT04234009
METC19-072

Details and patient eligibility

About

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 Stroke Association that a healthy lifestyle is one of the most effective strategies to protect against cognitive decline, the investigators now hypothesise that healthy lifestyle intervention-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 sedentary older men and women the effect of a 16-week aerobic-based exercise program 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 homeostatic model assessment for insulin resistance (HOMA-ir) and cognitive performance as assessed with a neurophysiological test battery.

Enrollment

10 patients

Sex

All

Ages

55 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • BMI between 25-35 kg/m2
  • Sedentary (assessed as low physically active using the International Physical Activity Questionnaire)
  • Right handedness and footedness
  • 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

  • Current smoker, or smoking cessation < 12 months
  • Diabetic patients
  • Familial hypercholesterolemia
  • Abuse of drugs
  • Consumption of more than 21 alcoholic units/week (men), or more than 14 alcoholic units/week (women)
  • Use of dietary supplements known to interfere with the main study 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, including permanent facial makeup, surgical clips/material in body, metal splinter in eye or claustrophobia

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

Healthy lifestyle
Experimental group
Description:
Healthy lifestyle intervention, which includes physical activity and dietary advice according to the dutch guidelines.
Treatment:
Other: Healthy Lifestyle
Control
No Intervention group
Description:
Maintenance of habitual physical activity and diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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