Body Weight, Diabetes Mellitus, Type 2, Metabolic Diseases, Metabolic Syndrome x, Nutrition Disorders, Obesity
Conditions
Keywords
nutritional support, diet therapy, protein diet, isocaloric diet
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).
Interventions
OTHERHigh animal protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
OTHERHigh plant protein diet group
25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
Sponsors
Ministry of Food and Agriculture, Germany
Ernst von Bergmann Hospital
University Hospital Tuebingen
Institute of Gain Processing IGV GmbH, Potsdam
German Institute of Human Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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) |
| Changes of gastrointestinal microbiota | week 0 and 6 | Molecular mechanisms between nutrition, intestinal bacteria and host |
Countries
Germany
Outcome results
None listed