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| Name | Class |
|---|---|
| Ministry of Food and Agriculture, Germany | UNKNOWN |
| Ernst von Bergmann Hospital | OTHER |
| University Hospital Tuebingen | OTHER |
| Institute of Gain Processing IGV GmbH, Potsdam |
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This 6-week parallel randomised prospective dietary intervention study with type 2 Diabetes investigates the nutrition influence of animal protein in comparison to plant protein on the glucose metabolism.
2x20 patients with Diabetes mellitus type 2 are randomise by a blind computer assist for an equal allocation in both groups (animal protein vs. plant protein). The food components for both groups are 40% carbohydrates, 30% fat and 30% protein. The carbohydrates are correspond with a high fiber content and a low blood sugar effectiveness of carbohydrates (glycemic index).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High animal protein diet group AP | Other | 6-weeks diet intervention with high animal protein |
|
| High plant protein diet group PP | Other | 6-weeks diet intervention with high plant protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High animal protein diet group | Other | 25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variance of glucose metabolism after different diet intervention | Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT) | week 0 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Development of indices for the prediction of liver fat mass | Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy | week 0 and 6 |
| Development of indices for the prediction of body fat mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas FH Pfeiffer, Prof | German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Institute of Human Nutrition | Potsdam-Rehbruecke | Nuthetal | 14558 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33893355 | Derived | Kabisch S, Markova M, Hornemann S, Sucher S, Pivovarova-Ramich O, Machann J, Hierholzer J, Rohn S, Pfeiffer AFH. Liver fat scores do not reflect interventional changes in liver fat content induced by high-protein diets. Sci Rep. 2021 Apr 23;11(1):8843. doi: 10.1038/s41598-021-87360-2. | |
| 30967307 | Derived | Markova M, Koelman L, Hornemann S, Pivovarova O, Sucher S, Machann J, Rudovich N, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AFH, Aleksandrova K. Effects of plant and animal high protein diets on immune-inflammatory biomarkers: A 6-week intervention trial. Clin Nutr. 2020 Mar;39(3):862-869. doi: 10.1016/j.clnu.2019.03.019. Epub 2019 Mar 27. |
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| UNKNOWN |
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| High plant protein diet group | Other | 25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks |
|
Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA)
| week 0, 2, 4 and 6 |
| Expression Change of inflammatory markers in blood and fat tissue | Measurement of gene expression of inflammation cytokines | week 0 and 6 |
| Modification of epigenetic DNA | week 0 and 6 |
| Changes of gastrointestinal microbiota | Molecular mechanisms between nutrition, intestinal bacteria and host | week 0 and 6 |
| Variance of composite biometric data | Change of blood pressure, weight, body mass index, waist-hip ratio | week 0, 2, 4 and 6 |
| Variance of blood data | Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers | week 0, 2, 4 and 6 |
| Variance of intestinal hormones | Change of intestinal hormones measured with a meal time test (MTT) | week o and 6 |
| 29982277 | Derived | Markova M, Hornemann S, Sucher S, Wegner K, Pivovarova O, Rudovich N, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AFH. Rate of appearance of amino acids after a meal regulates insulin and glucagon secretion in patients with type 2 diabetes: a randomized clinical trial. Am J Clin Nutr. 2018 Aug 1;108(2):279-291. doi: 10.1093/ajcn/nqy100. |
| 27765690 | Derived | Markova M, Pivovarova O, Hornemann S, Sucher S, Frahnow T, Wegner K, Machann J, Petzke KJ, Hierholzer J, Lichtinghagen R, Herder C, Carstensen-Kirberg M, Roden M, Rudovich N, Klaus S, Thomann R, Schneeweiss R, Rohn S, Pfeiffer AF. Isocaloric Diets High in Animal or Plant Protein Reduce Liver Fat and Inflammation in Individuals With Type 2 Diabetes. Gastroenterology. 2017 Feb;152(3):571-585.e8. doi: 10.1053/j.gastro.2016.10.007. Epub 2016 Oct 17. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009748 | Nutrition Disorders |
| D009765 | Obesity |
| D001835 | Body Weight |
| D024821 | Metabolic Syndrome |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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