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

German Institute of Human Nutrition44 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

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

Interventions

High animal protein diet groupOTHER

25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks

High plant protein diet groupOTHER

25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

German Institute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, Germany

Outcomes

Primary Outcomes

Variance of glucose metabolism after different diet intervention

Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)

Time frame: week 0 and 6

Secondary Outcomes

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

Time frame: 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)

Time frame: week 0, 2, 4 and 6

Expression Change of inflammatory markers in blood and fat tissue

Measurement of gene expression of inflammation cytokines

Time frame: week 0 and 6

Modification of epigenetic DNA

Time frame: week 0 and 6

Changes of gastrointestinal microbiota

Molecular mechanisms between nutrition, intestinal bacteria and host

Time frame: week 0 and 6

Variance of composite biometric data

Change of blood pressure, weight, body mass index, waist-hip ratio

Time frame: week 0, 2, 4 and 6

Variance of blood data

Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers

Data from ClinicalTrials.gov

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