Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects

Study Overview
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Brief Summary
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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
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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.

Official Title
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Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects

Conditions
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Overweight, Weight Loss

Intervention / Treatment
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* Dietary Supplement: ProbioSatys™
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years old males and females Overweight (Body Mass Index, BMI: 25 kg/m2 - 29.9 kg/m2) Generally in good health Desire to lose weight Regularly consuming 3 main meals/day (breakfast, lunch, dinner) 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 Stable body weight in the last 3 months prior to V1 (≤5% self-reported change) Stable concomitant medications (if any) for at least last 3 months prior to V1 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): No change in body weight or reduction up to 3 kg (compared to V1) Adequately completed subject diary Readiness and ability to comply with study requirements Relevant inclusion and exclusion criteria met Exclusion Criteria: Known allergy/sensitivity to any components of the investigational product Pathological electrocardiogram (ECG) at V1 History and/or presence of clinically significant self-reported disorder as per investigator's judgement: Untreated or non-stabilised thyroid gland disorder Untreated or non-stabilised hypertension (regular systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) Digestion/absorption disorders of the gastrointestinal tract (e.g. inflammatory bowel disease, coeliac disease, pancreatitis etc.) and/ or gastrointestinal surgery Diabetes mellitus type 1 or untreated/non-stabilised type 2 Acute or chronic psychotic disorder Immunodeficiency Any other organ or systemic diseases that could influence the conduct and/or outcome of the study and/or could affect the tolerability of the subject History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement Any electronic medical implant Deviation of safety laboratory parameter(s) at V1 that is: Clinically significant or >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome) Use of medication/supplementation in the last month prior to V1 and during the study, as per investigator's judgement: That could influence gastrointestinal functions (such as antibiotics, probiotics, laxatives, opioids, anticholinergics, anti-diarrheals etc.) For weight management (e.g. fat binder/burner, satiety products etc.) That could influence body weight (e.g. antidepressants, systemic corticoids etc.) That could otherwise interfere with study conduct / evaluation Diet/weight loss programs within the last 3 months prior to V1 and during the study Smoking cessation/modification of smoking level (if any) within 6 months prior to V1 and/or during the study (regular smoking during the study at the same level as prior to the study is allowed) Vegetarian, vegan or other restrictive diet Pregnancy or nursing History of or current abuse of drugs, alcohol or medication Inability to comply with study procedures Participation in another study during the last 30 days prior to V1 Any other reason deemed suitable for exclusion, per investigator's judgment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ProbioSatys™<br> | Dietary Supplement: ProbioSatys™<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who lost at least 3% of baseline body weight (=3% responders) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body fat free 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 | 
| 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) | continuous line between two endpoints: not saturated at all & fully saturated | 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 | 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 | 4, 8 and 12 weeks | 
| 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 | very good, good, moderate and poor | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Microbiome, Microbiota, Glucose Metabolism, Glycemia, Enterobacteriaceae, Gut-brain axis, Molecular mimicry, Hafnia alvei, Overweight, Food intake, Appetite regulation, Satiety, Weight loss