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

Not Applicable

Completed

• Conditions: Metabolic Syndrome x; Nutrition Disorders; Metabolic Diseases; Diabetes Mellitus, Type 2; Obesity; Body Weight
• Interventions: Other: High animal protein diet group; Other: High plant protein diet group

• Registration Number: NCT02402985
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-02-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-31
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High animal protein diet group AP	High animal protein diet group	6-weeks diet intervention with high animal protein
High plant protein diet group PP	High plant protein diet group	6-weeks diet intervention with high plant protein

Primary Outcome Measures

Name	Time	Method
Variance of glucose metabolism after different diet intervention	week 0 and 6	Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT)

Secondary Outcome Measures

Name	Time	Method
Development of indices for the prediction of liver fat mass	week 0 and 6	Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy
Development of indices for the prediction of body fat mass	week 0, 2, 4 and 6	Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA)
Expression Change of inflammatory markers in blood and fat tissue	week 0 and 6	Measurement of gene expression of inflammation cytokines
Modification of epigenetic DNA	week 0 and 6
Changes of gastrointestinal microbiota	week 0 and 6	Molecular mechanisms between nutrition, intestinal bacteria and host
Variance of composite biometric data	week 0, 2, 4 and 6	Change of blood pressure, weight, body mass index, waist-hip ratio
Variance of blood data	week 0, 2, 4 and 6	Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers
Variance of intestinal hormones	week o and 6	Change of intestinal hormones measured with a meal time test (MTT)

Trial Locations

Locations (1)

German Institute of Human Nutrition; 🇩🇪 Potsdam-Rehbruecke, Nuthetal, Germany