Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
LeguAN
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"
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedApril 30, 2015
April 1, 2015
1.5 years
February 4, 2015
April 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Development of indices for the prediction of liver fat mass
week 0 and 6
Development of indices for the prediction of body fat mass
week 0, 2, 4 and 6
Expression Change of inflammatory markers in blood and fat tissue
week 0 and 6
Modification of epigenetic DNA
week 0 and 6
Changes of gastrointestinal microbiota
week 0 and 6
- +3 more secondary outcomes
Study Arms (2)
High animal protein diet group AP
OTHER6-weeks diet intervention with high animal protein
High plant protein diet group PP
OTHER6-weeks diet intervention with high plant protein
Interventions
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Eligibility Criteria
You may qualify if:
- Diabetes mellitus, type 2
- HbA1c between 6-11%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- German Institute of Human Nutritionlead
- Ministry of Food and Agriculture, Germanycollaborator
- Ernst von Bergmann Hospitalcollaborator
- University Hospital Tuebingencollaborator
- Institute of Gain Processing IGV GmbH, Potsdamcollaborator
Study Sites (1)
German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, 14558, Germany
Related Publications (4)
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.
PMID: 33893355DERIVEDMarkova 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.
PMID: 30967307DERIVEDMarkova 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.
PMID: 29982277DERIVEDMarkova 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.
PMID: 27765690DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas FH Pfeiffer, Prof
German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director/Dep. Clinical Nutrition
Study Record Dates
First Submitted
February 4, 2015
First Posted
March 31, 2015
Study Start
September 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 30, 2015
Record last verified: 2015-04