The primary objective of this study is to validate the prediction model on the effect of a standardized mixed meal challenge on postprandial triglyceride levels in a heterogenous group of middle-aged, overweight to obese individuals. The secondary…
ID
Source
Brief title
Condition
- Other condition
- Lipid metabolism disorders
Synonym
Health condition
glucosemetabolismestoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the postprandial triglyceride responses in blood
upon a mixed meal challenge.
Secondary outcome
The secondary study parameters are: postprandial glucose and insulin responses
in the blood upon a mixed meal challenge, and extensive phenotyping of the
subjects by collecting data on fasting blood profiles of micronutrients,
metabolites, and proteins, continuous blood glucose levels (Freestyle Libre),
body fat composition (DEXA), liver fat percentage (MRI), habitual dietary
intake (FFQ), and physical activity (ActivPAL3).
Background summary
Elevated triglyceride and glucose levels are major risk factors for
cardiovascular diseases. Therefore, mitigating the postprandial increase in
triglyceride and glucose levels may help curb a person*s risk of developing
cardiovascular diseases. Current strategies to stimulate people to adopt a
healthy lifestyle, however, are still insufficient. This is partly due to the
fact that nutritional advice is nowadays still given at the population level
via general nutrition guidelines, while nutritionist have long been aware that
what works for one person may not work for another. Giving personalised dietary
advice will help mitigate the postprandial increases in triglyceride and
glucose levels, and will assist in the battle against the increase in
nutrition-related diseases, such as cardiovascular diseases.
Study objective
The primary objective of this study is to validate the prediction model on the
effect of a standardized mixed meal challenge on postprandial triglyceride
levels in a heterogenous group of middle-aged, overweight to obese individuals.
The secondary objectives are 1) to improve the accuracy of the predicted
postprandial TG responses by increasing the number of postprandial TG
measurements, 2) to determine which parameters can improve the accuracy of the
predicted postprandial TG responses, and 3) to determine if we can also predict
the effect of a standardized mixed meal challenge on postprandial glucose
levels in a heterogenous group of middle-aged, overweight to obese individuals,
and 4) to determine which parameters can improve the accuracy of the predicted
postprandial glucose responses.
Another objective is to determine how comparable triglyceride measurements in
blood are to measurements in dried blood spots.
Study design
An observational study with three visits, including one mixed meal challenge
test day
Study burden and risks
This study is related to a broad general population. There are minor risks for
the research subjects of this study. Consumption of the liquid mixed meal may
cause some gastro-intestinal discomfort. Blood sampling will be performed via a
cannula and the insertion can be a bit painful and may cause a bruise. The
amount of blood that is drawn from subjects is within acceptable limits (total
amount collected = 186mL). The radiation dose received during the DEXA scan for
measuring body composition is negligible compared to the average dose each
person in the Netherlands receives per year. Research subjects will invest
approximately 13.5 hours in the study. They will visit the Wageningen
University research facility three times: once for a short screening, once to
collect phenotyping data, and once for a mixed-meal challenge test day. In
addition, they will visit Hospital Gelderse Vallei once for an MRI measurement.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
- Male or female
- Age 45-75 y
- BMI 25-35 kg/m2
- Suitable veins for insertion of cannula
Exclusion criteria
- Having a gastro-intestinal disease, such as celiac disease, Crohn*s disease,
or Ulcerative colitis
- Having a history of intestinal surgery that might interfere with study
outcomes, as determined by the medical supervisor. This does not include an
appendectomy or cholecystectomy
- Presence of significant systemic diseases, such as diabetes mellitus, cancer,
cardiovascular disease or respiratory disease, as determined by the medical
supervisor
- Use of medications known to interfere with glucose or lipid homeostasis (e.g.
corticosteroids, cholesterol-lowering medication, insulin, metformin), as
determined by medical supervisor
- Blood clotting disorders
- Unstable body weight (weight gain or loss >3 kg in the past three months)
- Reported slimming, medically prescribed or other extreme diets
- Alcohol consumption >21 glasses a week
- Anaemia (Hb values <7.5 mmol/L for women and <8.5 mmol/L for men; checked at
screening)
- Pregnant, lactating or wishing to become pregnant in the period of the study
(self-reported)
- Having a pacemaker, ICD, hearing implant, internal insulin pump,
neurostimulator, aneurysm clips placed before 1990, or metal splinter in the eye
- Having claustrophobia
- Not willing to give up blood donation during the study
- Food allergies or intolerances for products that we use in the study
- Unwilling to consume non-vegan test meal
- Recent use of antibiotics (<3 months prior to study start)
- Current smokers
- Abuse of soft and/or hard drugs
- Participation in another clinical trial at the same time
- Being an employee of the Food, Health & Consumer Research group of Wageningen
Food & Biobased Research or Human Nutrition and Health Department of Wageningen
University
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 | NL79685.091.21 |
| Other | volgt nog |