Lifestyle and Brain Vascular Function

NCT04234009 | Terminated

• 1 other identifier: METC19-072
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Brain vascular function

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

  Baseline (0 weeks)

• Brain vascular function

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

  After intervention (16 weeks)

Secondary Outcomes (2)

• Cognitive performance

  Baseline (0 weeks) and after intervention (16 weeks)

• Glucose metabolism

  Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks)

Other Outcomes (31)

• Flow-Mediated Vasodilation (FMD)

  Baseline (0 weeks) and after intervention (16 weeks)

• Carotid Artery Reactivity (CAR)

  Baseline (0 weeks) and after intervention (16 weeks)

• Pulse Wave Analysis (PWA)

  Baseline (0 weeks) and after intervention (16 weeks)

Study Arms (2)

Healthy lifestyle

EXPERIMENTAL

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

Other: Healthy Lifestyle

Control

NO INTERVENTION

Maintenance of habitual physical activity and diet

Interventions

Healthy Lifestyle OTHER

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.

Healthy lifestyle

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Peter J. Joris, Dr

  Maastricht University

  PRINCIPAL INVESTIGATOR

• Ronald P. Mensink, Dr

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 21, 2020
• Study Start: January 22, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

NL (1)