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Comparison of two formula diets for weight reductio

Not Applicable
Conditions
E66
Obesity
Registration Number
DRKS00005481
Lead Sponsor
eibniz Universität Hannover, Institut für Lebensmittelwissenschaft und Humanernährung, Abteilung Ernährungsphysiologie und Humanernährung
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
160
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

- 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

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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