Trial document





This trial has been registered retrospectively.
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  DRKS00016536

Trial Description

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Title

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

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Trial Acronym

LSD-Study (Liquid-Solid-Diet-Study)

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URL of the Trial

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Brief Summary in Lay Language

The trillions of bacteria residing in the human gut may play an important role in the development of obesity and metabolic diseases. Often, very low calorie liquid diets are used to treat obesity, however in many cases this is followed by substantial weight regain. So far, it is unknown whether these low calorie liquid diets have different effects on the composition of gut bacteria than solid foods. Therefore, this study investigates whether the texture of foods (liquid versus solid) that are similar in caloric and nutrient content independently affects the composition of gut bacteria. For this, overweight or obese participants receive 5 days of low calorie liquid and 5 days of low calorie solid diets that are similar in caloric and nutrient content. Stool samples are frequently collected before, during and after diet periods. Genomic sequencing methods are then used to describe the bacterial composition.

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Brief Summary in Scientific Language

Caloric content and nutrient composition of a diet substantially affect the human gut microbiome which has been shown to play a role in the development of obesity and metabolic diseases. However, it is unknown whether low calorie liquid diets that are often used for the treatment of obesity have a specific effect on the gut microbiome that is solely attributable to its liquid nature. To investigate whether the texture of a diet affects the human gut microbiome independently from its caloric and nutrient content, overweight and obese participants are recruited to undergo 5 days of low caloric liquid and low caloric solid diet similar in caloric and nutrient content in a randomized cross-over design. Experimental diet periods are separated by an ad libitum diet period. Stool samples are collected before, after and between the experimental diets. Genetic sequencing e.g. of the 16S rRNA gene is used for taxonomic analysis.

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Organizational Data

  •   DRKS00016536
  •   2019/01/10
  •   [---]*
  •   yes
  •   Approved
  •   EA4/034/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Obesity ICD10 E66.00, E66.01
    Overweight
  •   E66.00 -  [generalization E66.0: Obesity due to excess calories]
  •   E66.01 -  [generalization E66.0: Obesity due to excess calories]
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Interventions/Observational Groups

  •   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 micronutrient content) for 5 days. Stool samples are collected before, during and after each diet period.
  •   800 kcal per day of a solid diet (matched to the liquid diet in macro- and micronutrient content) for 5 days, followed by an ad libitum diet phase for 5 days, followed 800 kcal per day of a liquid diet (Optifast) for 5 days. Stool samples are collected before, during and after each diet period.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group), Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

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

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/06/26
  •   11
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

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

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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

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte
    • Mr.  MD  Reiner   Jumpertz-von Schwartzenberg 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte
    • Mr.  MD  Reiner  Jumpertz-von Schwartzenberg 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.