Overweight, Weight Loss
Conditions
Keywords
Probiotics, Microbiome, Microbiota, Hafnia alvei, Overweight, Food intake, Appetite regulation, Satiety, Weight loss, Glucose Metabolism, Glycemia, Enterobacteriaceae, Gut-brain axis, Molecular mimicry
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTProbioSatys™
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.
OTHERPlacebo
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.
Sponsors
Analyze & Realize
TargEDys
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 65 years old males and females 2. Overweight (Body Mass Index, BMI: 25 kg/m2 - 29.9 kg/m2) 3. Generally in good health 4. Desire to lose weight 5. Regularly consuming 3 main meals/day (breakfast, lunch, dinner) 6. Readiness to comply with study procedures, in particular: * Follow diet recommendation * Maintain the habitual level of physical activity during the study * Fill out the questionnaires and subject diary * Take the IP as instructed 7. Stable body weight in the last 3 months prior to V1 (≤5% self-reported change) 8. Stable concomitant medications (if any) for at least last 3 months prior to V1 9. Women of childbearing potential: * Negative pregnancy testing (beta HCG-test in urine) at V1 * Women of childbearing potential: commitment to use contraception methods (with the exception of starting new contraception medication) Participation is based upon written informed consent form by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. Randomisation criteria (to be checked after run-in at V2): 1. No change in body weight or reduction up to 3 kg (compared to V1) 2. Adequately completed subject diary 3. Readiness and ability to comply with study requirements 4. Relevant inclusion and
Exclusion criteria
met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who lost at least 3% of baseline body weight (=3% responders) | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body fat free mass assessed per bioelectrical impedance analysis (BIA), compared to baseline | 4, 8 and 12 weeks | — |
| Lipid metabolism parameters (low density lipid cholesterol), compared to screening values (V1) | 14 weeks | — |
| Fasting glucose, compared to screening values (V1) | 14 weeks | — |
| Glycated haemoglobin (HbA1c), compared to screening values (V1) | 14 weeks | — |
| Evaluation of the overall feeling of satiety compared to baseline by using visual analogue scales (VAS) | 4, 8 and 12 weeks | continuous line between two endpoints: not saturated at all & fully saturated |
| Evaluation of the overall feeling of fullness compared to baseline by using visual analogue scales (VAS) | 4, 8 and 12 weeks | continuous line between two endpoints: not full at all & extremely full |
| Evaluation of the overall feeling of craving compared to baseline by using a 5 point Likert scale | 4, 8 and 12 weeks | 0= no, 1= slightly, 2= moderate, 3= strong and 4= very strong |
| General well-being parameters (Impact of Weight on Quality of Life-Lite, IWQOL-LITE), compared to baseline | 4, 8 and 12 weeks | — |
| Global evaluation of benefit at V5 by subject and the investigator | 12 weeks | very good, good, moderate and poor |
| Body weight change (in kg), compared to baseline (V2) | 4, 8 and 12 weeks | — |
| Body weight change (%), compared to baseline (V2) | 4, 8 and 12 weeks | — |
| Body weight (in kg ) | 4, 8 and 12 weeks | — |
| Proportion of subjects who lost at least 3% of baseline body weight (=3% responders) | 4 and 8 weeks | — |
| Proportion of subjects who lost at least 5% of baseline body weight (=5% responders) | 4, 8 and 12 weeks | — |
| Body fat mass assessed per bioelectrical impedance analysis (BIA), compared to baseline | 4, 8 and 12 weeks | — |
| Waist circumference, compared to baseline | 4, 8 and 12 weeks | — |
| Hip circumference, compared to baseline | 4, 8 and 12 weeks | — |
| Lipid metabolism parameters (total cholesterol), compared to screening values (V1) | 14 weeks | — |
| Lipid metabolism parameters (high density lipid cholesterol), compared to screening values (V1) | 14 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pulse rate, compared to baseline | 4, 8 and 12 weeks | — |
| Safety laboratory parameters, compared to screening values (V1) | 14 weeks | analysis of full blood count parameters (haemoglobin) |
| Global evaluation of tolerability at V5 by subject and the investigator | 12 weeks | very good, good, moderate and poor |
| Gastrointestinal tolerability parameters (Gastrointestinal Symptom Rating Scale questionnaire, GSRS), compared to baseline | 4, 8 and 12 weeks | — |
| Stool frequency in the week before each visit post- baseline, each compared to the week before baseline (V2) | 4, 8 and 12 weeks | — |
| Physical activity parameters (Global Physical Activity Questionnaire, GPAQ), compared to baseline | 4, 8 and 12 weeks | — |
| Assessment of adverse events throughout the study | 14 weeks | — |
| Blood pressure, compared to baseline | 4, 8 and 12 weeks | — |
Countries
Germany
Outcome results
None listed