E66
Conditions
Interventions
Group 1: Group 1: intake of protein-rich formula diet
In the first two weeks participants have to replace all three meals a day by the formula diet. The next two weeks follows the replacement of two
Sponsors
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: - caucasian men and women at the age of 30-65 years - Body Mass Index between 28,0 and 35,0 kg/m² - proband's written agreement to investigation after oral and written education about study content, demands and risks - proband's willingness to replace one meal by a formula diet and to consume two fatbinding tablets per day - proband's willingness to follow the given recommendations concerning nutrition and physical acitvity
Exclusion criteria
Exclusion criteria: - severe chronic illness (manifest coronary heart disease, cancer) - insulin-dependent diabetes mellitus Typ I and II - severe kidney or liver diseases - chronic gastroinestinal diseases (especially small intestine e.g. duodenal ulcer, liver, pancreas) and state after gastrointestinal surgical procedure e.g. nontropical sprue, short bowel syndrome) - stomach stapling operations, gastric band - known endokrine and immunological diseases -Hormonal disorders, for example, hyperthyroidism and Cushing's syndrome -Treatment with non-insulin-releasing antidiabetics (guar, acarbose) -Acute potassium-and magnesium-deficient - lactose or fructose malabsorption - intolerance towards soy and milk protein - continuous intake of laxatives - existing intolerances or allergies to ingredients of the diet (eg nuts, wheat) - continuous intake of corticosteroids (not inhalation), psychotropic drugs - pregnancy - lactation - addiction to alcohol and/or drugs - immediate planned surgery - simultaneous participation at another clinical trial or participation within the last 30 days - missing consent - refusing / reset of the consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight, waist circumference at any appointment (week 0, week 2, week 8, week 20) | — |
Secondary
| Measure | Time frame |
|---|---|
| body mass index (BMI), Bioelectrical impedance analysis, blood pressure, waist, waist to hip ratio several blood parameters (e.g. glucose, insulin, total cholesterol (TC),high-density-lipoprotein (HDL), low-density-lipoprotein (LDL), triglyceride (TG), Immunological parameters (hsCRP), questionnaire at any appointment (week 0, week 2, week 8, week 20) | — |
Countries
Germany
Contacts
Public ContactKatharina Möller
Leibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Outcome results
None listed