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| Name | Class |
|---|---|
| Technical University of Denmark | OTHER |
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Objective: To identify how specific changes of the whole grain content in the diet affect the host-gut microbiome interactions with implications for metabolic health .
Design: A randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week intervention periods, separated by a 6-week wash-out period. A total of 60 participants will be included.
Intervention: low vs. high whole grain intake.
The study is designed as a randomized, controlled, single-blinded, cross-over intervention trial consisting of two 8-week interventions periods, separated by a 6-week wash-out period. A total number of 60 participants will be included. Participants consume, in randomized order, a diet rich in whole grain in the active treatment period and a refined grain diet during the control period.
Measurements: Insulin sensitivity will be assessed by means of a meal challenge test and by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) which is the primary outcome of this study. Secondary outcomes include metabolic and inflammatory markers, appetite hormones, transit time, and GM composition. Furthermore, selected control measures are included; 4-day food records and a study intervention diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refined grain | Placebo Comparator | Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population) |
|
| Whole grain | Active Comparator | Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole grain | Other | Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HOMA-IR | Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5) | At the end of the intervention periods |
| Metagenomic profile | Altered quantitative metagenomics at bacterial gene- and species levels, which is a non-specific outcome, but included as the main hypothesis of the project is to test if HOMA-IR is affected via changes in the gut microbiome. | At the end of the intervention periods |
| Measure | Description | Time Frame |
|---|---|---|
| Mean intestinal transit time | Participants are instructed in swallowing capsules containing different small non-invasive and non-absorbable plastic pellets for 6 consecutive days. On the seventh day they are having an X-ray of the abdomen taken. | At the end of the intervention periods |
| Gastrointestinal permeability, Lactulose/ mannitol ratio |
| Measure | Description | Time Frame |
|---|---|---|
| 4-days precoded food diary | Assessment of dietary intake via food frequency questionnaire as a measure of compliance | December 2014 |
| n-3 fatty acid status | Assessed as DHA percentage in a whole blood fatty acid analysis. Included as a potential effect modificator in relation to immune function and metabolic outcomes. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lotte Lauritzen, Associate professor | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, University of Copenhagen | Fredriksberg | 1958 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29499850 | Derived | Lind MV, Lauritzen L, Vestergaard H, Hansen T, Pedersen O, Kristensen M, Ross AB. One-carbon metabolism markers are associated with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2018 Apr;28(4):402-410. doi: 10.1016/j.numecd.2018.01.005. Epub 2018 Jan 31. | |
| 29097438 | Derived | Roager HM, Vogt JK, Kristensen M, Hansen LBS, Ibrugger S, Maerkedahl RB, Bahl MI, Lind MV, Nielsen RL, Frokiaer H, Gobel RJ, Landberg R, Ross AB, Brix S, Holck J, Meyer AS, Sparholt MH, Christensen AF, Carvalho V, Hartmann B, Holst JJ, Rumessen JJ, Linneberg A, Sicheritz-Ponten T, Dalgaard MD, Blennow A, Frandsen HL, Villas-Boas S, Kristiansen K, Vestergaard H, Hansen T, Ekstrom CT, Ritz C, Nielsen HB, Pedersen OB, Gupta R, Lauritzen L, Licht TR. Whole grain-rich diet reduces body weight and systemic low-grade inflammation without inducing major changes of the gut microbiome: a randomised cross-over trial. Gut. 2019 Jan;68(1):83-93. doi: 10.1136/gutjnl-2017-314786. Epub 2017 Nov 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000067348 | Whole Grains |
| ID | Term |
|---|---|
| D002523 | Edible Grain |
| D018556 | Crops, Agricultural |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Refined grain | Other | Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population) |
|
5 hours urine collection following intake of lactulose and mannitol |
| At the end of the intervention periods |
| Colonic fermentation | Measurement of breath hydrogen excretion (at before and 30, 60, 90, 120, 150, 180 after intake of standard breakfast) and plasma short-chain fatty acids (fasting and 30, 60, 120, 180 minutes after standard breakfast) | At the end of the intervention periods |
| Saliva microbial flora | Determination of fasting microbial composition of flora. | At the end of the intervention periods |
| Blood pressure | Measurement of supine systolic and diastolic blood pressure (3 times) | At the end of the intervention periods |
| Appetite hormones | Determination of different appetite hormones in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast) | At the end of the intervention periods |
| Blood lipid profile | Measurement of different blood lipids in fasting and postprandial blood samples (30, 60, 120, 180 minutes after standard breakfast) | At the end of the interventions periods |
| Body composition | Measurement of body fat mass and percentage via bio-impedance | At the end of the intervention periods |
| Subjective appetite sensation | Assessment of subjective appetite sensation via visual analogue scales | At the end of the intervention periods |
| Energy intake | Assessment of energy intake at an ad libitum meal 3 hours after a standard breakfast | At the end of the intervention periods |
| Ex vivo cytokine production | Production of cytokines (such as IL-1beta, IL-6) in stimulated whole blood cultures. | At the end of the intervention periods |
| Gene expression | Assessed by mRNA qPCR in whole blood and cells from whole blood stimulation. Main focus is put on genes involved in immune function and metabolic regulation. | At the end of the intervention periods |
| Immune cell profiling | Assessed by flow cytometry of whole blood. | At the end of the intervention periods |
| Immune markers | Fasting plasma cytokines, hsCRP, and LPS/LPS-BP | At the end of the intervention periods |
| Blood immune cell content | Assessed by hematological cell counts | At the end of the intervention periods |
| Markers og glucose hemostasis | Measurement of plasma concentrations of Insulin, Proinsulin and HbA1c | At the end of the intervention periods |
| Markers of one-carbon metabolism | Assessed by plasma homocystein, SAM/SAH and betain | At the end of the intervention periods |
| Plasma adipokines | Leptin and adiponectin | December 2015 |
| At the end of the intervention periods |
| Alkyresorcinol | Measured in plasma as a marker of compliance to the whole grain intervention. | At the end of the intervention periods |
| 27629576 | Derived | Lind MV, Madsen ML, Rumessen JJ, Vestergaard H, Gobel RJ, Hansen T, Lauritzen L, Pedersen OB, Kristensen M, Ross AB. Plasma Alkylresorcinols Reflect Gluten Intake and Distinguish between Gluten-Rich and Gluten-Poor Diets in a Population at Risk of Metabolic Syndrome. J Nutr. 2016 Oct;146(10):1991-1998. doi: 10.3945/jn.116.236398. Epub 2016 Sep 14. |
| D010829 |
| Physiological Phenomena |
| D012639 | Seeds |
| D019602 | Food and Beverages |