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

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ClinicalTrials.gov Identifier: NCT02402985
Recruitment Status : Completed
First Posted : March 31, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborators:
Ministry of Food and Agriculture, Germany
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
University Hospital Tuebingen
Institute of Gain Processing IGV GmbH, Potsdam
Information provided by (Responsible Party):
Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Nutrition Disorders Obesity Body Weight Metabolic Syndrome x Metabolic Diseases Other: High animal protein diet group Other: High plant protein diet group Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Expression Change of inflammatory markers in blood and fat tissue [ Time Frame: week 0 and 6 ]
    Measurement of gene expression of inflammation cytokines

  4. Modification of epigenetic DNA [ Time Frame: week 0 and 6 ]
  5. Changes of gastrointestinal microbiota [ Time Frame: week 0 and 6 ]
    Molecular mechanisms between nutrition, intestinal bacteria and host

  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

  7. Variance of blood data [ Time Frame: week 0, 2, 4 and 6 ]
    Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers

  8. Variance of intestinal hormones [ Time Frame: week o and 6 ]
    Change of intestinal hormones measured with a meal time test (MTT)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402985


Locations
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Germany
German Institute of Human Nutrition
Potsdam-Rehbruecke, Nuthetal, Germany, 14558
Sponsors and Collaborators
German Institute of Human Nutrition
Ministry of Food and Agriculture, Germany
Klinikum Ernst von Bergmann Augenklinik Laserzentrum
University Hospital Tuebingen
Institute of Gain Processing IGV GmbH, Potsdam
Investigators
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Principal Investigator: Andreas FH Pfeiffer, Prof German Institute of Human Nutrition, Potsdam-Rehbrücke, Nuthetal, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. med. Andreas F. H. Pfeiffer, Director/Dep. Clinical Nutrition, German Institute of Human Nutrition
ClinicalTrials.gov Identifier: NCT02402985    
Other Study ID Numbers: BMLEV-Project
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015
Keywords provided by Prof. Dr. med. Andreas F. H. Pfeiffer, German Institute of Human Nutrition:
nutritional support
diet therapy
protein diet
isocaloric diet
Additional relevant MeSH terms:
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Metabolic Syndrome
Diabetes Mellitus, Type 2
Metabolic Diseases
Nutrition Disorders
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases