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

April 29, 2015 updated by: Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

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"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nuthetal
      • Potsdam-Rehbruecke, Nuthetal, Germany, 14558
        • German Institute of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variance of glucose metabolism after different diet intervention
Time Frame: week 0 and 6
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
Time Frame: week 0 and 6
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
Time Frame: week 0, 2, 4 and 6
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
Time Frame: week 0 and 6
Measurement of gene expression of inflammation cytokines
week 0 and 6
Modification of epigenetic DNA
Time Frame: week 0 and 6
week 0 and 6
Changes of gastrointestinal microbiota
Time Frame: week 0 and 6
Molecular mechanisms between nutrition, intestinal bacteria and host
week 0 and 6
Variance of composite biometric data
Time Frame: week 0, 2, 4 and 6
Change of blood pressure, weight, body mass index, waist-hip ratio
week 0, 2, 4 and 6
Variance of blood data
Time Frame: week 0, 2, 4 and 6
Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers
week 0, 2, 4 and 6
Variance of intestinal hormones
Time Frame: week o and 6
Change of intestinal hormones measured with a meal time test (MTT)
week o and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Institute of Human Nutrition

Collaborators

University Hospital Tuebingen
Ernst von Bergmann Hospital
Ministry of Food and Agriculture, Germany
Institute of Gain Processing IGV GmbH, Potsdam

Investigators

  • Principal Investigator: Andreas FH Pfeiffer, Prof, German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMLEV-Project

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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