Healthy Lifestyle Clinical Trial
Official title:
The Effects of a Healthy Lifestyle Intervention on Brain Vascular Function in Older People
Verified date | April 2021 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Flow-Mediated Vasodilation (FMD) | Peripheral vascular function, endothelial function | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Carotid Artery Reactivity (CAR) | Peripheral vascular function, endothelial function | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Pulse Wave Analysis (PWA) | Peripheral vascular function, vascular stiffness | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Pulse Wave Velocity (PWV) | Peripheral vascular function, vascular stiffness | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Retinal microvascular calibers | Peripheral vascular function, microcirculation | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Blood pressure (systolic, diastolic and mean pressure) | Office and 24-hour ambulatory blood pressure | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Serum lipid profile concentration | Concentration of serum lipids | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Serum insulin concentration | Concentration of insulin in serum | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Plasma glucose concentration | Concentration of glucose in plasma | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Homeostatic Model Assessment for Insulin Resistance (HOMA-ir) | HOMA-ir is a method used to quantify insulin resistance and beta-cell function | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Circulating markers for low-grade systemic inflammation | Markers for low-grade systemic inflammation (IL-6, TNF-alpha) | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Circulating markers for microvascular function | Markers for microvascular function (sCAM-1, vWf, cGMP) | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Circulating marker of neurogenesis | Brain-derived neurotrophic factor (BDNF) | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Glycated haemoglobin (HbA1C) | HbA1C is a form of hemoglobin (abbreviated Hb) that is chemically linked to a sugar. | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Aerobic fitness | Incremental exhaustive exercise test (Maximal oxygen consumption and power output) | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Physical fitness (1) | Incremental exhaustive exercise test (Maximal Power output) | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Physical fitness (2) | The 6-minute walk test (6 MWT) | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Activity monitoring | activPAL activity monitor | Baseline (0 weeks) and after intervention (16 weeks) for four consecutive days | |
Other | Self reported physical activity | The International Physical Activity Questionnaire | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Food frequency questionnaire | Self reported food consumption | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Dutch Healthy Diet index 2015 | Compliance to the Dutch dietary guidelines based on the FFQ | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Quality of Life score | The Quality of life will be assessed using a 32-item questionnaire | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Sleep characteristics | Sleep characteristics will be assessed using the 10-item Pittsburgh Sleep Quality Index | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Fat mass | Body composition measured with whole body air-displacement by the BodPod | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Fat free mass | Body composition measured with whole body air-displacement by the BodPod | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Anthropometrics (1) | Weight | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Anthropometrics (2) | BMI | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Anthropometrics (3) | Waist and hip circumference (ratio) | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) | |
Other | Structural brain status (1) | MRI MPRAGE | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Structural brain status (2) | T2FLAIR | Baseline (0 weeks) and after intervention (16 weeks) | |
Other | Structural brain status (3) | R2* | Baseline (0 weeks) and after intervention (16 weeks) | |
Primary | Brain vascular function | Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL) | Baseline (0 weeks) | |
Primary | Brain vascular function | Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL) | After intervention (16 weeks) | |
Secondary | Cognitive performance | Cambridge Neuropsychological Test Automated Battery (CANTAB) | Baseline (0 weeks) and after intervention (16 weeks) | |
Secondary | Glucose metabolism | Homeostatic Model Assessment for Insulin Resistance (HOMA-ir) and HbA1c | Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks) |
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