Lifestyle and Brain Vascular Function

Healthy Lifestyle Clinical Trial

Official title:

The Effects of a Healthy Lifestyle Intervention on Brain Vascular Function in Older People

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04234009
• Other study ID #: METC19-072
• Status: Terminated
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: April 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Other:
• Healthy Lifestyle
The physical activity guidelines for older consist of 150 minutes per week moderate-to-high intensity exercise, two times per week muscle and bone strengthening exercises, which are combined with balance exercises. Additional health benefits can be achieved with a longer exercise duration, frequency and/or intensity. Furthermore, the amount of time sitting should be minimised. The dietary guidelines are described in detail in the so-called "The Wheel of Five". In brief, the circle is divided into four food groups and one beverage group. More than half of the circle is covered by fruits, vegetables, whole grain (containing) breads, cereals and potatoes. A much smaller part is compromised by animal source foods, spreads and cooking fats. Water, tea and coffee without sugar complete the circle.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

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)