Wageningen Universiteit Division of Human Nutrition
Wageningen, Gelderland, 6703HD, Netherlands
NCT Number: NCT02385149
This study investigates the health benefits of whole grain wheat on cardiovascular/ cardio-metabolic health, including glucose metabolism, by means of applying a mixed meal challenge. This study also investigates the health benefits of whole grain wheat (WGW) on liver- and adipose tissue health and evaluates the potential of do-it-yourself (DIY) devices in quantifying health effects in a nutritional intervention study.
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Notify Me45 year–70 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6703HD, Netherlands
The study is a randomized controlled, double blind, parallel trial. A 4-week run-in period with refined wheat (RW) products will be included prior to the intervention for all subjects. Thereafter, two different treatments will be evaluated e.g. a 12-week intervention with whole grain wheat (WGW) products (98g of WGW per day) and a 12-week control intervention with RW products. Two experimental visits will be planned before and two experimental visits will be planned after the 12-week intervention period. In the first experimental visit the investigators will determine liver fat and abdominal fat distribution by magnetic resonance spectroscopy (MRS) and magnetic resonance imaging (MRI). In the second experimental visit the investigators will comprehensively phenotype the participants which will include the response to a mixed meal challenge test.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The inclusion of subjects with mildly impaired cardio-metabolic risk profiles enables detection of improvements in health after WGW consumption. The investigators therefore aim to include 50 middle aged and overweight males or postmenopausal females (45-70yrs and BMI between 25-35 kg/m2) that have mildly elevated levels of cholesterol (cholesterol levels > 5 mmol/L). In case the inclusion of subjects with mildly elevated levels of total cholesterol is too difficult, normal levels of total cholesterol (< 5 mmol/L) can be accepted, but with a minimum total cholesterol level of 4.5 mmol/L.
Inclusion criteria
Exclusion criteria
A twelve week intervention of 98g whole grain wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
A twelve week control intervention of refined wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
Time frame: Baseline and after 12 week intervention (at 0 and 12 weeks) , during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial)
parameters include change in cholesterol, TAG, glucose, insulin, FMD (Fasting only), pulse wave analysis (Fasting and 120, 240min postprandial), blood pressure(Fasting and 120, 240min postprandial), blood cell activation (Fasting only) and plasma markers of cardio-vascular health
Time frame: Baseline and after 12 week intervention (at 0 and 12 weeks), during fasting and in response to a mixed meal challenge test (at 30,60,120,240 min postprandial)
parameters include change in intrahepatic lipid accumulation (by MRS, at -1 and 11 weeks), abdominal body fat distribution (by MRI, at -1 and 11 weeks), adipose tissue gene expression (adipose tissue biopsy, fasting only), blood markers of liver health
Time frame: At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)
DIY tests are optional and include glucose, cholesterol, blood pressure and a OGTT (only week 8). These tests are performed by the subjects.
Time frame: At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks)
health and mood questionaires (some questionaires are every 4weeks)
Time frame: before and after 12 week intervention (at 0 and 12 weeks)
such as alkylresorinol
Time frame: Baseline and after 12 week intervention (at 0 and 12 weeks), during fasting and in response to a mixed meal challenge test (at 60 and 240 min postprandial)
gene expression
Time frame: Baseline and after 12 week intervention (at 0 and 12 weeks, during fasting and in response to a mixed meal challenge test (at 10,30,60,120,240 min postprandial)
parameters include questionaires and blood markers of satiety
Time frame: Baseline and after 12 week intervention (at 0 and 12 weeks)
To determine markers of compliance and microbiota profiling
Wageningen University
Other
Acronym: Graandioos
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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