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| Name | Class |
|---|---|
| TNO | OTHER |
| Cereal Partners Worldwide | INDUSTRY |
| Nederlands Bakkerij Centrum | OTHER |
| Goodmills |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whole grain wheat | Experimental | 98g whole grain wheat per day for 12 weeks |
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| refined wheat | Experimental | coloured refined wheat control intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole grain wheat | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardio-metabolic health parameters (composite) | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver-and adipose tissue health parameters (composite) | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peripheral blood mononuclear cells | gene expression | 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) |
| Change in markers of satiety (composite) |
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:
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| Name | Affiliation | Role |
|---|---|---|
| Lydia Afman, PhD | Wageningen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wageningen Universiteit Division of Human Nutrition | Wageningen | Gelderland | 6703HD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36330140 | Derived | Gijbels A, Schutte S, Esser D, Wopereis S, Gonzales GB, Afman LA. Effects of a 12-week whole-grain or refined wheat intervention on plasma acylcarnitines, bile acids and signaling lipids, and association with liver fat: A post-hoc metabolomics study of a randomized controlled trial. Front Nutr. 2022 Oct 13;9:1026213. doi: 10.3389/fnut.2022.1026213. eCollection 2022. | |
| 33188417 |
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| UNKNOWN |
| University Medical Center Groningen | OTHER |
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| refined wheat | Other | 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). |
|
| Change in do-it-yourself measure outcomes (composite) | DIY tests are optional and include glucose, cholesterol, blood pressure and a OGTT (only week 8). These tests are performed by the subjects. | At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks) |
| Change in health and mood questionaire outcomes | health and mood questionaires (some questionaires are every 4weeks) | At baseline and every two weeks during the intervention (at 0,2,4,6,8,10,12 weeks) |
| Change in blood markers of whole grain intake | such as alkylresorinol | before and after 12 week intervention (at 0 and 12 weeks) |
parameters include questionaires and blood markers of satiety |
| 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) |
| Urine and faecal collection | To determine markers of compliance and microbiota profiling | Baseline and after 12 week intervention (at 0 and 12 weeks) |
| van Trijp MPH, Schutte S, Esser D, Wopereis S, Hoevenaars FPM, Hooiveld GJEJ, Afman LA. Minor Changes in the Composition and Function of the Gut Microbiota During a 12-Week Whole Grain Wheat or Refined Wheat Intervention Correlate with Liver Fat in Overweight and Obese Adults. J Nutr. 2021 Mar 11;151(3):491-502. doi: 10.1093/jn/nxaa312. |
| 31504709 | Derived | Hoevenaars FPM, Esser D, Schutte S, Priebe MG, Vonk RJ, van den Brink WJ, van der Kamp JW, Stroeve JHM, Afman LA, Wopereis S. Whole Grain Wheat Consumption Affects Postprandial Inflammatory Response in a Randomized Controlled Trial in Overweight and Obese Adults with Mild Hypercholesterolemia in the Graandioos Study. J Nutr. 2019 Dec 1;149(12):2133-2144. doi: 10.1093/jn/nxz177. |
| 30541093 | Derived | Schutte S, Esser D, Hoevenaars FPM, Hooiveld GJEJ, Priebe MG, Vonk RJ, Wopereis S, Afman LA. A 12-wk whole-grain wheat intervention protects against hepatic fat: the Graandioos study, a randomized trial in overweight subjects. Am J Clin Nutr. 2018 Dec 1;108(6):1264-1274. doi: 10.1093/ajcn/nqy204. |