Comparative study of the effects of a low caloric liquid diet versus a low caloric solid diet on the composition of the gut microbiome of healthy overweight/obese subjects

Not Applicable

Recruiting

• Conditions: Obesity ICD10 E66.00, E66.01Overweight; E66.00; E66.01

• Registration Number: DRKS00016536
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

Male; Age 18-65 Years; Body Mass Index 25,0-39,99 kg/m2

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diversity and composition of the human gut microbiome assessed by 16S rRNA gene sequencing

Secondary Outcome Measures

Name	Time	Method
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. <br>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. <br>3. Body weight; Timepoint: Screening, begin and end of each experimental diet. <br>4. Relative and absolut body fat content assessed by body plethysmography or biometrical impedance; Timepoint: Begin and end of each experimental diet.<br>5. Hormones such as Ghrelin, Leptin, PYY, Insulin, etc. in the fasting state; Timepoint: Screening, begin and end of each experimental diet.<br>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.