The primary objective of this intervention study is to evaluate in sedentary elderly men and women the effect of a 16-week healthy lifestyle intervention on cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline and follow-up, participants have to attend the research facilities
for one day to perform measurements. The primary endpoint is the effect of a
16-week healthy lifestyle intervention on cerebral blood flow, as assessed by
Arterial Spin Labeling.
Secondary outcome
Cognitive performance and HOMA-ir
Background 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 healthy lifestyle
is one of the most effective strategies to protect against cognitive decline,
we now hypothesize that healthy lifestyle induced changes in glucose metabolism
cause beneficial effects on brain vascular function thereby improving cognitive
performance.
Study objective
The primary objective of this intervention study is to evaluate in sedentary
elderly men and women the effect of a 16-week healthy lifestyle intervention 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 peripheral glucose
metabolism using the homeostatic model assessment for insulin resistance
(HOMA-ir) and cognitive performance as assessed with a neuropsychological test
battery.
Study design
The proposed study will have a randomized, controlled, parallel design. The
total study duration will be sixteen weeks.
Intervention
The intervention group will follow a 16-week healthy lifestyle intervention,
which includes physical activity according to the dutch guidelines and dietary
advice adhering to the guidelines described in the *wheel of five*.
Participants will receive thorough instructions about the guidelines at the
baseline and intermediate visit at the university and will be monitored every
two weeks via e-mail or telephone.
Study burden and risks
Participants will be screened to determine eligibility during one visit of 30
minutes. During these screening visits, we will measure antropometrics and
blood pressure will be determined. Additionally, a resting 12-lead ECG will
also be recorded and a venous blood sample (9.0 mL) will be drawn. During the
healthy lifestyle intervention, participants will receive instructions to
comply to the Dutch nutrition and movement guidelines, which will be monitored
every two weeks. The healthy lifestyle intervention is safe and there are no
expected side effects related to the intervention. During the trial
measurements will be performed and blood will be sampled (a total of 210 mL
during the whole trial) at baseline, intermediate and at follow-up visit.
During these tests, participants have to visit the university and are not
allowed to eat. Some study participants may report pain during venipuncture.
Arterial Spin Labeling perfusion MRI non-invasively records cerebral blood flow
without any significant risks. Measurements will be performed on a Siemens 3.0
Tesla Magnetom Prisma Fit scanner. No contrast medication or radioactive tracer
substance will be administered to the participants. Other measurements are
routine in our metabolic research unit (MRUM) and are not expected to lead to
physical side effects. Participants that not fully adhere to the study protocol
will be excluded from the statistical analyses, because a per protocol analysis
will be performed. The total time investment, excluding travelling time, is
approximately 14 hours.
Universiteitsingel 50
Maastricht 6229ER
NL
Universiteitsingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Aged between 55-70 years
- BMI between 25-35 kg/m2 (overweight and slightly obese)
- Sedentary (assessed as low physically active using the International Physical
Activity Questionnaire)
- Rights 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71184.068.19 |