The primary objectives are to investigate in older men and women the effect of 16-week peanut consumption on brain vascular function and brain insulin-sensitivity in cognitive-control brain areas, while we will also focus on changes in cognitive…
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Health condition
cognitieve stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline, first anthropometric measurements will be performed and blood
pressure will be determined. In addition, a fasting blood sample will be drawn.
Another fasting blood sample will be drawn at eight weeks, while participants
have to attend the research facilities to perform follow-up measurements after
sixteen weeks. The primary endpoint is the difference at follow-up in the
cerebral blood flow response before and after intranasal insulin administration
between interventions.
Secondary outcome
Cognitive performance that will be assessed with a neuropsychological test
battery is the secondary endpoint.
Background summary
Impaired brain vascular function precedes the development of reduced cognitive
performance, while brain insulin-resistance is also associated with cognitive
decline. Peanut consumption has already been shown to beneficially affect
cognitive performance. However, underlying mechanisms have not yet been
established, while well-controlled trials on longer-term effects of peanuts on
cognitive performance are highly needed. We hypothesize that longer-term peanut
consumption improves (regional) brain vascular function and
insulin-sensitivity, thereby improving cognitive performance in older men and
women.
Study objective
The primary objectives are to investigate in older men and women the effect of
16-week peanut consumption on brain vascular function and brain
insulin-sensitivity in cognitive-control brain areas, while we will also focus
on changes in cognitive performance as assessed with a neuropsychological test
battery (secondary objective). Cerebral blood flow responses before (brain
vascular function) and after the administration of intranasal insulin (brain
insulin sensitivity) will be non-invasively quantified by the non-invasive gold
standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin
Labeling (ASL).
Study design
This intervention study will have a randomized, controlled, cross-over design.
The total study duration will be 40 weeks, including two 16-week interventions,
separated by a washout period of at least 8 weeks.
Intervention
Study participants will receive in random order daily 60 g of skin roasted
peanuts (peanut intervention) or no peanuts for a total of 16 weeks (control
intervention), separated by a wash-out period of at least 8 weeks.
Study burden and risks
Subjects will be screened to determine eligibility during one visit of 20
minutes. During these screening visits, anthropometric measurements will be
performed and blood pressure will be determined. In addition, a fasting blood
sample (5.5 mL) will be drawn. During the peanut intervention, adults will
receive daily 60 g of peanuts for sixteen weeks. These regimens were
well-tolerated in previous trials and are safe, and there are no expected side
effects related to the nut consumption. During the trial on different
occasions, tests will be performed and blood will be sampled (a total of 245.5
mL during the whole trial). During these tests, subjects have to stay at the
university and are not allowed to eat. Some study subjects may report pain
during venipuncture. Insertion of the cannula can cause some discomfort and
possible a hematoma or bruise. Some adults may also report pain during the
insertion of the cannula. Arterial Spin Labeling perfusion MRI non-invasively
records cerebral blood flow without any significant risks. MRI 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. Brain insulin-sensitivity will be assessed by quantifying acute
effects of insulin as nasal spray on cerebral blood flow, which is safe and is
used in a study from our research group already (METC 19-058). This is also
being used by experts at the University of Tübingen (Germany) and Leiden
University Medical Centre (protocol code numbers P13.164 and NL45043.058.13).
Other measurements are routine 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 is 12 hours (720 minutes), excluding
travel time. The study will provide insight into the potential beneficial
effect of peanuts on brain function in older men and women.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Aged between 60-75 years
- BMI between 20-35 kg/m2
- 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
- Allergy or intolerance to nuts
- Left handedness
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use of nuts or dietary supplements known to interfere with the main 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 (e.g. pacemaker, surgical clips/material
in body, metal splinter in eye, claustrophobia)
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 | NL82095.068.22 |