The primary objective of the present study is to investigate the postprandial effect of arginine-rich protein (i.e. pea-protein) on metabolic control, inflammation and endothelial function after a high-fat meal in subjects with the metabolic…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
main study parameters include postprandial responses in metabolic factors
(insulin, glucose, triglycerides), inflammation markers and endothelial
function (tonography) .
Secondary outcome
secundary studie parameters are changes in satiety markers (GLP) and changes in
oxidative stress as measured in PBMCs
Background summary
Arginine is potential interesting considering the metabolic syndrome. Studies
so far indicated both long-term effects, as well as acute - postprandial -
actions; especially when metabolism is already challenged, e.g. in diabetic
patients or after a high-fat meal. However, whether arginine-rich proteins are
equally effective is not known. Moreover, a careful examination of the effect
of (arginine rich) protein on postprandial (dys)metabolism and inflammation is
hardly performed.
Study objective
The primary objective of the present study is to investigate the postprandial
effect of arginine-rich protein (i.e. pea-protein) on metabolic control,
inflammation and endothelial function after a high-fat meal in subjects with
the metabolic syndrome. Secondly, the effect of an arginie-rich protein will be
compared to protein low in arginine (i.e. gluten protein). Finally, it will be
evaluated whether the protein-hydrolysate has additional advantages.
Study design
Double-blind, controlled challenge study, cross-over Latin square design
Intervention
High-fat meal without (CON) or with added protein: pea-protein (PP),
gluten-protein (GP) or their hydrolysates (PPH and GPH respectively)
Study burden and risks
During a screening visit 6 ml blood will be drawn after an overnight fast and
body weight, length, waist and blood pressure will be measured. An oral glucose
tolerance test will be performed. A general and medical questionnaire will be
used.
During the study period of 8 weeks each participant will visit the University
on 5 days, separated by at least one week, and will consume within 15 minutes a
milkshake containing 95 grams of fat with or without added 30 g protein. Blood
will be collected both before consuming the milkshakes (baseline, T=0) and
every hour after consumption of the shakes until 6 hours (T=1-6), using a
venous cathteter (venflon0. In total 100 mL will be sampled during a single
test day. Endothelial function (ED) will be measured at T=0, T=3 and T=6 hrs.
Body composition of the participants will be measured in the Bod Pod.
The time investment requested from the participants is 1 hour at the
information meeting, 2.5 hours at a screening session, 5 x 7 hours at the
intervention days. The risks associated with venous blood drawing using the
venflon technique, ED and body composition measurements are minimal. Blood
sampling can result in a local haematoma, and can cause discomfort. The
consumption of the milkshakes is not expected to be associated with discomfort,
but could, in rare cases, have adverse effects such as a mild gastrointestinal
discomfort (belching, flatulence or loose stools).
Postbus 8129
6700 EV Wageningen
NL
Postbus 8129
6700 EV Wageningen
NL
Listed location countries
Age
Inclusion criteria
male
* central obesity: waist circumference >=94 cm
plus any one of the following four factors:
* raised triglyceride level: >=1.7 mmol/L;
* reduced high-density lipoprotein (HDL) cholesterol: <1.03 mmol/L
* raised blood pressure: systolic blood pressure >=130 mmHg or diastolic BP >=85 mmHg or use of blood pressure lowering medication
* raised fasting plasma glucose >= 5.6 mmol/L
Additional inclusion criteria:
* age 45-65 years
* body weight should be stable for at least 6 months
* stable exercise habits during the last 6 months, and not participating in any vigorous exercise program
Exclusion criteria
* (undiagnosed) diabetes - but not impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) as evaluated by an oral glucose tolerance test at screening (plasma glucose: fasting > 7.0 and/or 2-hours > 11.1 mmol/L)
* High triglyceride levels (> 5 mmol/L) or high blood pressure (> 160/95 mmHg) at screening
* Low haemoglobin level at screening (< 7.5 mmol/L)
* active hearth disease, i.e. history of myocardial infarction or angina pectoris
* following, or have recently followed a (weight-loss) diet
* drug uses knowing to interfere with the objectives of the study
- oral corticosteroids, lipid-lowering drugs (statins)
- ACE-inhibitors
* Allergic to cow milk / dairy products or gluten
* vegetarians
* Received inoculations within 2 months of starting or planned to during the study
* Donated or intended to donate blood 2 months before till two months after the study
* abuse of drugs and/or alcohol
* tobacco smoker
* participation in another biomedical study within 1 month before the first screening visit
* Not wanting to be informed about chance-findings during screening
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 | NL32078.081.10 |