The primary objective of the current intervention trial is to evaluate in elderly men and women the effect of a 16-week soy treatment on gray matter cerebral blood flow, as quantified by the non-invasive gold standard magnetic resonance imaging (MRI…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline, anthropometric measurements will be first performed and a fasting
blood sample will be drawn. After sixteen weeks, adults have to attend two
times the research facilities to perform follow-up measurements. The primary
endpoint is the difference at follow-up in mean gray matter cerebral blood
flow, as assessed by Arterial Spin Labeling, between the soy and control
treatment.
Secondary outcome
Not applicable.
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 American Stroke Association that healthy
plant-based diets, which consist of soy foods, protect against cognitive
decline, we now hypothesize that soy-induced changes in glucose metabolism
cause beneficial effects on brain vascular function thereby improving cognitive
performance.
Study objective
The primary objective of the current intervention trial is to evaluate in
elderly men and women the effect of a 16-week soy treatment on gray matter
cerebral blood flow, as quantified by the non-invasive gold standard magnetic
resonance imaging (MRI) perfusion method Arterial Spin Labeling (ASL). In fact,
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 oral glucose tolerance test and cognitive performance as
assessed with a neurophysiological test battery.
Study design
The proposed study will have a randomized, controlled, cross-over design. The
total study duration will be 40 weeks, including two 16-week treatments,
separated by a washout period of 8 weeks.
Intervention
Study volunteers will receive, in random order, daily 70 g of soy nuts (roasted
soybeans containing approximately 100 mg isoflavones) (soy treatment) or no
food products (control treatment) for sixteen weeks, separated by an eight-week
wash-out period.
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 venous blood
sample (5.5 mL) will be drawn. During the soy treatment, adults will receive
daily 70 g of soy nuts for sixteen weeks. This soy-nut regimen was
well-tolerated in a previous trial and is safe, and there are no expected side
effects related to the soy treatment. During the trial on different occasions,
tests will be performed and blood will be sampled (a total of 325.5 mL during
the whole trial). During these tests, subjects have to stay at the university
and are not allowed to eat. Some 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 brain perfusion
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. Other measurements are routine and are also 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 18 hours
(1080 minutes), excluding travel time.
Universiteitsingel 50
Maastricht 6229 ER
NL
Universiteitsingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Aged between 60-70 years
- BMI between 20-30 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 soy
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic consumptions per day
- Use of soy products 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 | NL65613.068.18 |