The study aims to evaluate the effects of ProbioSatys™ on body weight and related parameters in overweight subjects during a 12-week consumption period. In addition, tolerability and safety of ProbioSatys™ will be assessed.
ProbioSatys™ is a probiotic nutritional solution containing a commensal Enterobacteriaceae food grade strain, Hafnia alvei 4597. The microbiome is known to play a crucial role in body weight management and metabolic disease. ProbioSatys™ mechanism of action relies on bacterial metabolites that send local and central signals via the gut-brain axis by molecularly mimicking satiety hormones involved in appetite regulation. Numerous ProbioSatys™pre-clinical studies indicate that consumption of the strain leads to body weight loss based on food intake reduction, but also improvement of body composition (increase of lean mass/fat mass ratio), and improvement of glucose metabolism (oral glucose tolerance test, and fasted glycemia). The present study aims to evaluate the effects of ProbioSatys™ on body weight and related parameters in overweight subjects during a 12-week consumption period. In addition, tolerability and safety of ProbioSatys™ will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
236
One capsule, twice a day, is to be orally taken with 100 mL of water during each breakfast and lunch (approx. 5 minutes after starting eating), total 2 capsules per day.
One capsule, twice a day, is to be orally taken with 100 mL of water during each breakfast and lunch (approx. 5 minutes after starting eating), total 2 capsules per day.
Analyze & Realize
Berlin, Germany
Barbara Grube
Berlin, Germany
Jörg Förstermann
Berlin, Germany
Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")
Time frame: 12 weeks
Body weight change (in kg), compared to baseline (V2)
Time frame: 4, 8 and 12 weeks
Body weight change (%), compared to baseline (V2)
Time frame: 4, 8 and 12 weeks
Body weight (in kg )
Time frame: 4, 8 and 12 weeks
Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")
Time frame: 4 and 8 weeks
Proportion of subjects who lost at least 5% of baseline body weight (="5% responders")
Time frame: 4, 8 and 12 weeks
Body fat mass assessed per bioelectrical impedance analysis (BIA), compared to baseline
Time frame: 4, 8 and 12 weeks
Body fat free mass assessed per bioelectrical impedance analysis (BIA), compared to baseline
Time frame: 4, 8 and 12 weeks
Waist circumference, compared to baseline
Time frame: 4, 8 and 12 weeks
Hip circumference, compared to baseline
Time frame: 4, 8 and 12 weeks
Lipid metabolism parameters (total cholesterol), compared to screening values (V1)
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Time frame: 14 weeks
Lipid metabolism parameters (high density lipid cholesterol), compared to screening values (V1)
Time frame: 14 weeks
Lipid metabolism parameters (low density lipid cholesterol), compared to screening values (V1)
Time frame: 14 weeks
Fasting glucose, compared to screening values (V1)
Time frame: 14 weeks
Glycated haemoglobin (HbA1c), compared to screening values (V1)
Time frame: 14 weeks
Evaluation of the overall feeling of satiety compared to baseline by using visual analogue scales (VAS)
continuous line between two endpoints: not saturated at all \& fully saturated
Time frame: 4, 8 and 12 weeks
Evaluation of the overall feeling of fullness compared to baseline by using visual analogue scales (VAS)
continuous line between two endpoints: not full at all \& extremely full
Time frame: 4, 8 and 12 weeks
Evaluation of the overall feeling of craving compared to baseline by using a 5 point Likert scale
0= "no", 1= "slightly", 2= "moderate", 3= "strong" and 4= "very strong"
Time frame: 4, 8 and 12 weeks
General well-being parameters (Impact of Weight on Quality of Life-Lite, IWQOL-LITE), compared to baseline
Time frame: 4, 8 and 12 weeks
Global evaluation of benefit at V5 by subject and the investigator
"very good", "good", "moderate" and "poor"
Time frame: 12 weeks