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Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics (LeguAN)

Primary Purpose

Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High animal protein diet group
High plant protein diet group
Sponsored by
German Institute of Human Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring nutritional support, diet therapy, protein diet, isocaloric diet

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Institute of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

High animal protein diet group AP

High plant protein diet group PP

Arm Description

6-weeks diet intervention with high animal protein

6-weeks diet intervention with high plant protein

Outcomes

Primary Outcome Measures

Variance of glucose metabolism after different diet intervention
Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)

Secondary Outcome Measures

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
Development of indices for the prediction of body fat mass
Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA)
Expression Change of inflammatory markers in blood and fat tissue
Measurement of gene expression of inflammation cytokines
Modification of epigenetic DNA
Changes of gastrointestinal microbiota
Molecular mechanisms between nutrition, intestinal bacteria and host
Variance of composite biometric data
Change of blood pressure, weight, body mass index, waist-hip ratio
Variance of blood data
Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers
Variance of intestinal hormones
Change of intestinal hormones measured with a meal time test (MTT)

Full Information

First Posted
February 4, 2015
Last Updated
April 29, 2015
Sponsor
German Institute of Human Nutrition
Collaborators
Ministry of Food and Agriculture, Germany, Ernst von Bergmann Hospital, University Hospital Tuebingen, Institute of Gain Processing IGV GmbH, Potsdam
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1. Study Identification

Unique Protocol Identification Number
NCT02402985
Brief Title
Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
Acronym
LeguAN
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Institute of Human Nutrition
Collaborators
Ministry of Food and Agriculture, Germany, Ernst von Bergmann Hospital, University Hospital Tuebingen, Institute of Gain Processing IGV GmbH, Potsdam

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity, Body Weight, Metabolic Syndrome x, Metabolic Diseases
Keywords
nutritional support, diet therapy, protein diet, isocaloric diet

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High animal protein diet group AP
Arm Type
Other
Arm Description
6-weeks diet intervention with high animal protein
Arm Title
High plant protein diet group PP
Arm Type
Other
Arm Description
6-weeks diet intervention with high plant protein
Intervention Type
Other
Intervention Name(s)
High animal protein diet group
Intervention Description
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Intervention Type
Other
Intervention Name(s)
High plant protein diet group
Intervention Description
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Primary Outcome Measure Information:
Title
Variance of glucose metabolism after different diet intervention
Description
Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)
Time Frame
week 0 and 6
Secondary Outcome Measure Information:
Title
Development of indices for the prediction of liver fat mass
Description
Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
Time Frame
week 0 and 6
Title
Development of indices for the prediction of body fat mass
Description
Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA)
Time Frame
week 0, 2, 4 and 6
Title
Expression Change of inflammatory markers in blood and fat tissue
Description
Measurement of gene expression of inflammation cytokines
Time Frame
week 0 and 6
Title
Modification of epigenetic DNA
Time Frame
week 0 and 6
Title
Changes of gastrointestinal microbiota
Description
Molecular mechanisms between nutrition, intestinal bacteria and host
Time Frame
week 0 and 6
Title
Variance of composite biometric data
Description
Change of blood pressure, weight, body mass index, waist-hip ratio
Time Frame
week 0, 2, 4 and 6
Title
Variance of blood data
Description
Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers
Time Frame
week 0, 2, 4 and 6
Title
Variance of intestinal hormones
Description
Change of intestinal hormones measured with a meal time test (MTT)
Time Frame
week o and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas FH Pfeiffer, Prof
Organizational Affiliation
German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Institute of Human Nutrition
City
Potsdam-Rehbruecke
State/Province
Nuthetal
ZIP/Postal Code
14558
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33893355
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.
Results Reference
derived
PubMed Identifier
30967307
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.
Results Reference
derived
PubMed Identifier
29982277
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.
Results Reference
derived
PubMed Identifier
27765690
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.
Results Reference
derived

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Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics

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