E66.0
Conditions
Interventions
Group 1: verum group: intake of two fatbinding tablets per day
Group 2: Placebo group: intake of two placebo tablets per day
Sponsors
Leibniz Universität Hannover
Institut für Lebensmittelwissenschaft und Ökotrophologie
Abteilung Ernährungsphysiologie und Humanernährung
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: - caucasian men and women at the age of 30-60 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 chd, 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 - lactose malabsorption - intolerance towards soy and milk protein - continuous intake of laxatives - 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, BMI at any appointment (week 0, week 6, week 12, week 18) | — |
Secondary
| Measure | Time frame |
|---|---|
| waist circumference, Bioelectrical impedance analysis, blood pressure, several blood parameters (e.g. glucose, insulin, TC, HDL, LDL, TG), questionnaire at any appointment (week 0, week 6, week 12, week 18) | — |
Countries
Germany
Contacts
Public ContactJanina Postler
Leibniz Universität Hannover Institut für Lebensmittelwissenschaft und Ökotrophologie Abteilung Ernährungsphysiologie und Humanernährung
Outcome results
None listed