Overweight E65-E68
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Written informed consent of the study participants after detailed verbal and written explanation of the study content, requirements and risks - Ability and willingness to follow the investigator's instructions - BMI: 28.0-35.0 kg/m2
Exclusion criteria
Exclusion criteria: - Severe chronic diseases (diagnosed diabetes, cardiovascular diseases, liver diseases, renal insufficiency, cancer) - Chronic diseases of the gastrointestinal tract (especially small intestine, liver, pancreas) and condition following surgery on the gastrointestinal tract; e.g. gastrectomy, sprue, enterocolitis, chronic pancreatitis, cholestasis, short bowel syndrome, chronic inflammatory bowel disease, not: appendicitis, gallstone surgery - Surgical procedures to reduce the size of the stomach, gastric banding, gastric balloon - Autoimmune diseases (e.g. Crohn's disease, ulcerative colitis, rheumatoid arthritis, multiple sclerosis) - Regular intake of laxatives - Regular use of immunosuppressive medication (e.g. corticosteroids (except inhaled)) - Pregnancy, breastfeeding period - Alcohol, drug and/or medication abuse - Immediate need for surgical intervention in the next 3 months - Simultaneous participation in another clinical trial or participation within the last 30 days - Study participants not capable of giving informed consent - Refusal or withdrawal of consent by study participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body-Mass-Index, measured at t0 and t12 | — |
Secondary
| Measure | Time frame |
|---|---|
| At t0 and t12: - Waist circumference (measurement with measuring tape) - Body composition (BIA measurement) Blood sampling and laboratory determination of: - Parameters of glucose metabolism (fasting glucose, insulin, HbA1c, HOMA index) - Parameters of lipid metabolism (LDL, HDL, total cholesterol, triglycerides) - Inflammation parameters (hsCRP) - CBC At t0, t6 and t12: - Survey of the consumption pattern using the modified FFQ - Survey of activity using the Freiburg questionnaire | — |
Countries
Germany
Contacts
Institut für Lebensmittelwissenschaft und Humanernährung Gottfried Wilhelm Leibniz Universität Hannover