Healthy LifestyleNCT04234009
Lifestyle and Brain Vascular Function
A study testing Healthy Lifestyle in people with Healthy Lifestyle and Physical Exercise, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle, Physical Exercise, Healthy Diet
- What is being tested?
- Healthy Lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jan 2020to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229 ER
About this study
Official title: The Effects of a Healthy Lifestyle Intervention on Brain Vascular Function in Older People
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
- Being tested
- Healthy Lifestyle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy LifestyleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy lifestyle | Experimental | Healthy lifestyle intervention, which includes physical activity and dietary advice according to the dutch guidelines. Receives: Other: Healthy Lifestyle |
| Control | No intervention | Maintenance of habitual physical activity and diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain vascular function
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Measured: Baseline (0 weeks)
Brain vascular function
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Measured: After intervention (16 weeks)
Secondary outcomes (2)
Cognitive performance
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: Baseline (0 weeks) and after intervention (16 weeks)
Glucose metabolism
Homeostatic Model Assessment for Insulin Resistance (HOMA-ir) and HbA1c
Measured: Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start22 Jan 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Not possible due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J. Joris, Dr, Principal investigator, Maastricht UniversityRonald P. Mensink, Dr, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234009
- Sponsor's protocol ID
- METC19-072
- Status last verified
- Apr 2021
- First submitted
- 20 Dec 2019
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Healthy Lifestyle Intervention on Brain Vascular Function in Older People
- ClinicalTrials.gov ID
- NCT04234009
- Acronym / sponsor ID
- METC19-072
- Conditions
- Healthy Lifestyle, Physical Exercise, Healthy Diet, Cerebrovascular Circulation, Cerebral Blood Flow, Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not possible due to COVID-19
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy lifestyle | Experimental | Other: Healthy LifestyleHealthy lifestyle intervention, which includes physical activity and dietary advice according to the dutch guidelines. |
| Control | No intervention | –Maintenance of habitual physical activity and diet |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy LifestyleThe 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. | Other | Healthy lifestyle |
Primary outcome
Brain vascular function
Time frame: Baseline (0 weeks)
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
Brain vascular function
Time frame: After intervention (16 weeks)
Cerebral blood flow as quantified non-invasively by the MRI perfusion method Arterial Spin Labeling (ASL)
2 secondary outcomes
Cognitive performance
Time frame: Baseline (0 weeks) and after intervention (16 weeks)
Glucose metabolism
Time frame: Baseline (0 weeks), at the middle (8 weeks) and after intervention (16 weeks)
Results and safety
The study was stopped early (reason given: Not possible due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J. Joris, Dr principal investigator
Maastricht University
Ronald P. Mensink, Dr principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Lifestyle in people with Healthy Lifestyle and Physical Exercise, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not possible due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain vascular function (time frame: Baseline (0 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021; AzTrials last refreshed its copy on 26 Oct 2026.