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

German Institute of Human Nutrition

Status

Completed

Conditions

Metabolic Diseases

Nutrition Disorders

Metabolic Syndrome x

Obesity

Body Weight

Diabetes Mellitus, Type 2

Treatments

Other: High plant protein diet group

Other: High animal protein diet group

Study type

Interventional

Funder types

Other

Identifiers

NCT02402985

BMLEV-Project

Details and patient eligibility

About

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.

Full 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).

Enrollment

44 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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