Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
NCT ID: NCT02402985
Last Updated: 2015-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2013-09-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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High animal protein diet group AP
6-weeks diet intervention with high animal protein
High animal protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
High plant protein diet group PP
6-weeks diet intervention with high plant protein
High plant protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Interventions
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High animal protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
High plant protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Eligibility Criteria
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Inclusion Criteria
* HbA1c between 6-11%
Exclusion Criteria
* Intake of metabolic influence a/o anticoagulent drugs (e.g. cortisone, ASS, antibiotics)
* Diabetes type 1
* Pregnancy
* Chronic disease of heart, kidney, liver
* High grade anaemia
* High grade infection disease
* Relevant change of body weight (+/- 5 kg) since 8 weeks before begin of study Intervention
* Missing data about primary outcome measures (hyperinsulinaemic euglycaemic clamp, mealtime test, data about dietary intake from food diaries or food protocols)
* Significant deviation from dietary targets during the monitored 6 weeks isoenergetic period
* Allergies including food allergies
18 Years
80 Years
ALL
No
Sponsors
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Ministry of Food and Agriculture, Germany
UNKNOWN
Ernst von Bergmann Hospital
OTHER
University Hospital Tuebingen
OTHER
Institute of Gain Processing IGV GmbH, Potsdam
UNKNOWN
German Institute of Human Nutrition
OTHER
Responsible Party
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Prof. Dr. med. Andreas F. H. Pfeiffer
Director/Dep. Clinical Nutrition
Principal Investigators
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Andreas FH Pfeiffer, Prof
Role: PRINCIPAL_INVESTIGATOR
German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
Locations
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German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, Germany
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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BMLEV-Project
Identifier Type: -
Identifier Source: org_study_id