Obesity ICD10 E66.00, E66.01 Overweight E66.00 E66.01
Conditions
Interventions
Group 1: 800 kcal per day of a liquid diet (Optifast) for 5 days, followed by an ad libitum diet phase for 5 days, followed 800 kcal per day of a solid diet (matched to the liquid diet in macro- and m
Sponsors
Charité Campus Charité Mitte
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Male; Age 18-65 Years; Body Mass Index 25,0-39,99 kg/m2
Exclusion criteria
Exclusion criteria: Specific diets due to medical reasons; Frequent probiotic use in last 3 months; Antibiotic used in last 3 months; Use of dietary supplements; Vegan diet; Specific nutrient intolerance; Participation in a weight loss program currently or during the last 3 months; Change in body weight of more than 5 kg during the prior month; Any disease or condition that is not compatible with the study due to evaluation by the study physician; Severe diseases of any kind that need immediate treatment; Post-surgical state; Acute and chronic infection; Legal incapacity; Any abuse of medical or illegal drugs or alcohol; Type 2 diabetes or use of oral antidiabetic drugs or insulin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diversity and composition of the human gut microbiome assessed by 16S rRNA gene sequencing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Abundance of Clostridium difficile by means of qPCR, sequencing and/or culture; Timepoint: all stool samples collected before during and after the experimental diets and in the wash-out phase. 2. Change in individual bacterial clades between the study groups analysed by multidimensional and machine learning algorithms; Timepoint: all stool samples collected before during and after the experimental diets and in the wash-out phase. 3. Body weight; Timepoint: Screening, begin and end of each experimental diet. 4. Relative and absolut body fat content assessed by body plethysmography or biometrical impedance; Timepoint: Begin and end of each experimental diet. 5. Hormones such as Ghrelin, Leptin, PYY, Insulin, etc. in the fasting state; Timepoint: Screening, begin and end of each experimental diet. 6. Fasting glucose and glucose, insulin during a 75g oral glucose tolerance test; Timepoint: Screening (fasting glucose) and at the end of the experimental diets. | — |
Countries
Germany
Contacts
Public ContactReiner Jumpertz-von Schwartzenberg
Charité Campus Charité Mitte
Outcome results
None listed