Clinical trial NCT02402985: Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
Official title: Comparison of a High-protein, Carbohydrate-restricted Diet With a High Proportion of Leguminous Protein Compared to Animal Protein on Metabolic Control in Patients With Type 2 Diabetes, "LeguAN Study"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Nutrition Disorders
Obesity
Body Weight
Metabolic Syndrome x
Metabolic Diseases
Keywords: nutritional support
diet therapy
protein diet
isocaloric diet
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Agriculture, Germany
name: Ernst von Bergmann Hospital
name: University Hospital Tuebingen
name: Institute of Gain Processing IGV GmbH, Potsdam
First posted: 2015-03-31
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus, type 2
* HbA1c between 6-11%

Exclusion Criteria:

* Consumptive or high grade diseases
* 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

Primary outcomes:
measure: Variance of glucose metabolism after different diet intervention
timeFrame: week 0 and 6
Secondary outcomes:
measure: Development of indices for the prediction of liver fat mass
timeFrame: week 0 and 6
measure: Development of indices for the prediction of body fat mass
timeFrame: week 0, 2, 4 and 6
measure: Expression Change of inflammatory markers in blood and fat tissue
timeFrame: week 0 and 6
measure: Modification of epigenetic DNA
timeFrame: week 0 and 6
measure: Changes of gastrointestinal microbiota
timeFrame: week 0 and 6
measure: Variance of composite biometric data
timeFrame: week 0, 2, 4 and 6
measure: Variance of blood data
timeFrame: week 0, 2, 4 and 6
measure: Variance of intestinal hormones
timeFrame: week o and 6
Other outcomes:
Locations:
city: Potsdam-Rehbruecke
country: Germany
facility: German Institute of Human Nutrition
state: Nuthetal
Study officials:
affiliation: German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
name: Andreas FH Pfeiffer, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.