Effectiveness of a multilateral weight reduction conceptio

Not Applicable

• Conditions: E66.0; Obesity due to excess calories

• Registration Number: DRKS00000325
• Lead Sponsor: eibniz Universität HannoverInstitut für Lebensmittelwissenschaft und ÖkotrophologieAbteilung Ernährungsphysiologie und Humanernährung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Study Completion: 2010-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
body weight, BMI at any appointment (week 0, week 6, week 12, week 18)

Secondary Outcome Measures

Name	Time	Method
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)