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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02402985
Other study ID # BMLEV-Project
Secondary ID
Status Completed
Phase N/A
First received February 4, 2015
Last updated April 29, 2015
Start date September 2013
Est. completion date March 2015

Study information

Verified date April 2015
Source German Institute of Human Nutrition
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Other:
High animal protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
High plant protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks

Locations

Country Name City State
Germany German Institute of Human Nutrition Potsdam-Rehbruecke Nuthetal

Sponsors (5)

Lead Sponsor Collaborator
German Institute of Human Nutrition Institute of Gain Processing IGV GmbH, Potsdam, Klinikum Ernst von Bergmann Augenklinik Laserzentrum, Ministry of Food and Agriculture, Germany, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variance of glucose metabolism after different diet intervention Change of insulin sensitivity measured by hyperinsulinaemic euglycaemic clamp and meal time test (MTT) week 0 and 6 No
Secondary Development of indices for the prediction of liver fat mass Change of fat fraction in liver, abdominal and in the total body fat measuring by MRI/H1-spectroscopy week 0 and 6 No
Secondary Development of indices for the prediction of body fat mass Change of body fat measuring by body composition assessment (BODPOD) and bioelectrical impedance analysis (BIA) week 0, 2, 4 and 6 No
Secondary Expression Change of inflammatory markers in blood and fat tissue Measurement of gene expression of inflammation cytokines week 0 and 6 No
Secondary Modification of epigenetic DNA week 0 and 6 No
Secondary Changes of gastrointestinal microbiota Molecular mechanisms between nutrition, intestinal bacteria and host week 0 and 6 No
Secondary Variance of composite biometric data Change of blood pressure, weight, body mass index, waist-hip ratio week 0, 2, 4 and 6 No
Secondary Variance of blood data Changes in the levels of composite circulating inflammatory and metabolic syndrome biomarkers week 0, 2, 4 and 6 No
Secondary Variance of intestinal hormones Change of intestinal hormones measured with a meal time test (MTT) week o and 6 No
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