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NCT Number: NCT02402985

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Institute of Human Nutrition

Potsdam-Rehbruecke, Nuthetal, 14558, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High animal protein diet group

Other

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

High plant protein diet group

Other

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

German Institute of Human Nutrition

Other

Collaborators

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

Registry information

Official study 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"

Acronym: LeguAN

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2015
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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