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

Obesity Clinical Trial

— 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402985
• Other study ID #: BMLEV-Project
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: April 29, 2015
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: German Institute of Human Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Other:
• High animal protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
• High plant protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks

Locations

Country	Name	City	State
Germany	German Institute of Human Nutrition	Potsdam-Rehbruecke	Nuthetal

Sponsors (5)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Institute of Gain Processing IGV GmbH, Potsdam, Klinikum Ernst von Bergmann Augenklinik Laserzentrum, Ministry of Food and Agriculture, Germany, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Expression Change of inflammatory markers in blood and fat tissue	Measurement of gene expression of inflammation cytokines	week 0 and 6	No
Secondary	Modification of epigenetic DNA		week 0 and 6	No
Secondary	Changes of gastrointestinal microbiota	Molecular mechanisms between nutrition, intestinal bacteria and host	week 0 and 6	No
Secondary	Variance of composite biometric data	Change of blood pressure, weight, body mass index, waist-hip ratio	week 0, 2, 4 and 6	No
Secondary	Variance of blood data	Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers	week 0, 2, 4 and 6	No
Secondary	Variance of intestinal hormones	Change of intestinal hormones measured with a meal time test (MTT)	week o and 6	No