The primary objective is to investigate in overweight or obese older adults the effect of daily protein supplementation for two weeks with either a plant-derived protein or an animal-derived protein on vascular function and insulin-sensitivity in…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 will be assessed with a neuropsychological test battery,
while we will also focus on appetite-related brain reward activity.
Background summary
Protein-rich foods may improve brain insulin-sensitivity, which is important
for cognitive and metabolic health, and may also translate into an improved
food intake regulation It is therefore pertinent to delineate the effects of
plant-derived proteins, which are a more sustainable alternative to
animal-derived proteins, on brain insulin-sensitivity and related functional
benefits. We now hypothesize that daily plant-derived or animal-derived protein
supplementation improves brain vascular function and insulin-sensitivity,
thereby improving cognitive performance and appetite control in overweight or
obese older men and women.
Study objective
The primary objective is to investigate in overweight or obese older adults the
effect of daily protein supplementation for two weeks with either a
plant-derived protein or an animal-derived protein on vascular function and
insulin-sensitivity in the brain, while we will also focus on changes in
cognitive performance and appetite-related brain reward activity (secondary
study objectives). Cerebral blood flow responses before (brain vascular
function) and after the administration of intranasal insulin spray (brain
insulin-sensitivity) will be quantified by the gold standard magnetic resonance
imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).
Study design
This intervention study will have a single-blind, randomized, controlled
cross-over design. The total study duration will be 18 weeks, including three
two-week intervention periods, separated by wash-out periods of at least six
weeks.
Intervention
Study participants will consume, in random order, twice daily (2 x 20 g) a
plant protein (fava bean protein isolate), animal protein (milk protein
isolate) or no extra protein (control) for two weeks, separated by six-week
wash-out periods.
Study burden and risks
Subjects will be screened to determine eligibility during one visit of 30
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. Participants will consume, in random order,
twice daily (2 x 20 g) a plant protein, animal protein or no extra protein
(control). Off note, protein supplementation regimens have already been
provided in previous trials and were well-tolerated. There are no expected side
effects related to daily protein supplementation. 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, study 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 participants 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 has
already been used in several studies from our research group before. 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 14 hours (840 minutes), excluding travel time.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Men and women, aged between 60-75 years
- BMI between 25-35 kg/m2 (overweight or obese)
- 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
- Intolerant to milk products or fava bean allergy
- Vegetarians
- 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 food 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 |
|---|---|
| Other | ClinicalTrials.gov registratie zal plaatsvinden na goedkeuring door de METC |
| CCMO | NL88040.068.24 |