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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2, Nutrition Disorders, Obesity, Body Weight, Metabolic Syndrome x, Metabolic Diseases

Intervention / Treatment
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* Other: High animal protein diet group
* Other: High plant protein diet group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High animal protein diet group AP<br>6-weeks diet intervention with high animal protein | Other: High animal protein diet group<br>* 25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks<br>|
| Other: High plant protein diet group PP<br>6-weeks diet intervention with high plant protein | Other: High plant protein diet group<br>* 25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutritional support, diet therapy, protein diet, isocaloric diet