Lifestyle and Brain Vascular Function

Not Applicable

Terminated

• Conditions: Healthy Diet; Cognitive Performance; Healthy Lifestyle; Physical Exercise; Cerebrovascular Circulation; Cerebral Blood Flow; Glucose Metabolism
• Interventions: Other: Healthy Lifestyle

• Registration Number: NCT04234009
• Lead Sponsor: Maastricht University Medical Center

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Study Start: 2020-01-22
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy lifestyle	Healthy Lifestyle	Healthy lifestyle intervention, which includes physical activity and dietary advice according to the dutch guidelines.

Primary Outcome Measures

Name	Time	Method
Brain vascular function	After intervention (16 weeks)	Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)

Secondary Outcome Measures

Name	Time	Method
Cognitive performance	Baseline (0 weeks) and after intervention (16 weeks)	Cambridge Neuropsychological Test Automated Battery (CANTAB)
Glucose metabolism	Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks)	Homeostatic Model Assessment for Insulin Resistance (HOMA-ir) and HbA1c

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Limburg, Netherlands