The primary objectives of this trial are to evaluate in overweight or obese adults (aged 60-75) with subjective cognitive decline (SCD) the effects of a 36-weeks NWT-03 intervention on (1) cognitive performance using a neurophysiological test…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are the difference in brain vascular function and
cognitive performance between interventions.
Secondary outcome
Secondary endpoints are effects on insulin-sensitivity and peripheral vascular
function.
Background summary
Age-related chronic diseases including dementia, type II diabetes mellitus
(T2DM) and cardiovascular disease (CVD) become more prevalent and of increasing
societal concern. Common denominators of these co-morbidities are
insulin-resistance and impaired vascular function. Animal and short-term human
studies now suggest that NWT-03 - an egg-protein hydrolysate - improves
insulin-sensitivity and peripheral vascular function, which are risk markers
for the development of T2DM and CVD. Insulin-resistance is also associated with
cognitive decline, while impaired brain vascular function is an important event
preceding the development of impaired cognitive performance. We have already
shown in a shorter-term trial (12 weeks) beneficial effects of a daily dose of
5.0 g of NWT-03 on cognitive performance. However, underlying mechanisms have
not yet been addressed, while the long-term effects remain unknown. Thus, we
now hypothesize that NWT-03 beneficially affects brain vascular function and
cognitive performance following long-term daily intake.
Study objective
The primary objectives of this trial are to evaluate in overweight or obese
adults (aged 60-75) with subjective cognitive decline (SCD) the effects of a
36-weeks NWT-03 intervention on (1) cognitive performance using a
neurophysiological test battery, and (2) cerebral blood flow, as quantified by
the current non-invasive gold standard magnetic resonance imaging (MRI)
perfusion method Arterial Spin Labeling (ASL). Secondary study objectives are
to examine effects on insulin-sensitivity and peripheral vascular function.
Study design
This intervention study will have a randomized, controlled, parallel design.
The total study duration will be 36 weeks.
Intervention
During the study, subjects will receive daily (in the morning) 5.7 g NWT*03 or
placebo powders for 36 weeks.
Study burden and risks
Subjects will be screened to determine eligibility during one visit of 20
minutes. During the screening visit, anthropometric measurements will be
performed and blood pressure will be determined. In addition, a fasting blood
sample (5.5 mL) will be drawn. After inclusion, subjects will be randomized.
Half of the subjects will receive daily NWT*03 and the other half placebo
powders. NWT-03 has already been provided in a similar dose and format during
previous trials and was well-tolerated. There were also no side effects related
to the intervention. The total study duration will be 36 weeks. During the
study, tests will be performed on different occasions, and blood will be
sampled (225.5 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 possibly a hematoma or bruise. Some adults may also report pain during the
insertion of the cannula. ASL 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 will be administered. Other measurements are also not
expected to lead to physical side effects. The total time investment is 18
hours (1080 minutes), excluding travel time. The study will provide insight
into the effects of NWT-03 on brain vascular function and cognitive performance
in older adults with subjective cognitive decline.
Universiteitsingel 50
Maastricht 6229ER
NL
Universiteitsingel 50
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
- Men and women, aged between 60-75 years
- Subjective cognitive decline (SCD)
- BMI between 25-35 kg/m2
- Fasting plasma glucose < 7.0 mmol/L
- Fasting serum total cholesterol < 8.0 mmol/L (further testing will be
performed for excessive hyperlipidemia [serum total cholesterol * 8.0 mmol/L]
according to the Standard for cardiovascular risk management of NHG)
- 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
- Left-handedness
- Current smoker, or smoking cessation < 12 months
- Diabetic patients
- Familial hypercholesterolemia
- Abuse of drugs
- More than 3 alcoholic units per day
- Use of products or dietary supplements known to interfere with the main
outcomes as judged by the principal investigators within the previous 1-month
- Use of medication to treat blood pressure, lipid or glucose metabolism
- Use of an investigational product within another 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 | NL75618.068.20 |