Clinical trial NCT03657186: Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
Official title: Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Weight Loss
Keywords: Probiotics
Microbiome
Microbiota
Hafnia alvei
Overweight
Food intake
Appetite regulation
Satiety
Weight loss
Glucose Metabolism
Glycemia
Enterobacteriaceae
Gut-brain axis
Molecular mimicry
Lead sponsor: TargEDys
Sponsor class: INDUSTRY
Collaborators: name: Analyze & Realize
First posted: 2018-09-04
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Exclusion Criteria:

1. Known allergy/sensitivity to any components of the investigational product
2. Pathological electrocardiogram (ECG) at V1
3. 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
4. History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
5. Any electronic medical implant
6. 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)
7. 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
8. Diet/weight loss programs within the last 3 months prior to V1 and during the study
9. 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)
10. Vegetarian, vegan or other restrictive diet
11. Pregnancy or nursing
12. History of or current abuse of drugs, alcohol or medication
13. Inability to comply with study procedures
14. Participation in another study during the last 30 days prior to V1
15. Any other reason deemed suitable for exclusion, per investigator's judgment

Primary outcomes:
measure: Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")
timeFrame: 12 weeks
Secondary outcomes:
measure: Body weight change (in kg), compared to baseline (V2)
timeFrame: 4, 8 and 12 weeks
measure: Body weight change (%), compared to baseline (V2)
timeFrame: 4, 8 and 12 weeks
measure: Body weight (in kg )
timeFrame: 4, 8 and 12 weeks
measure: Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")
timeFrame: 4 and 8 weeks
measure: Proportion of subjects who lost at least 5% of baseline body weight (="5% responders")
timeFrame: 4, 8 and 12 weeks
measure: Body fat mass assessed per bioelectrical impedance analysis (BIA), compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Body fat free mass assessed per bioelectrical impedance analysis (BIA), compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Waist circumference, compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Hip circumference, compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Lipid metabolism parameters (total cholesterol), compared to screening values (V1)
timeFrame: 14 weeks
measure: Lipid metabolism parameters (high density lipid cholesterol), compared to screening values (V1)
timeFrame: 14 weeks
measure: Lipid metabolism parameters (low density lipid cholesterol), compared to screening values (V1)
timeFrame: 14 weeks
measure: Fasting glucose, compared to screening values (V1)
timeFrame: 14 weeks
measure: Glycated haemoglobin (HbA1c), compared to screening values (V1)
timeFrame: 14 weeks
measure: Evaluation of the overall feeling of satiety compared to baseline by using visual analogue scales (VAS)
timeFrame: 4, 8 and 12 weeks
measure: Evaluation of the overall feeling of fullness compared to baseline by using visual analogue scales (VAS)
timeFrame: 4, 8 and 12 weeks
measure: Evaluation of the overall feeling of craving compared to baseline by using a 5 point Likert scale
timeFrame: 4, 8 and 12 weeks
measure: General well-being parameters (Impact of Weight on Quality of Life-Lite, IWQOL-LITE), compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Global evaluation of benefit at V5 by subject and the investigator
timeFrame: 12 weeks
Other outcomes:
measure: Assessment of adverse events throughout the study
timeFrame: 14 weeks
measure: Blood pressure, compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Pulse rate, compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Safety laboratory parameters, compared to screening values (V1)
timeFrame: 14 weeks
measure: Global evaluation of tolerability at V5 by subject and the investigator
timeFrame: 12 weeks
measure: Gastrointestinal tolerability parameters (Gastrointestinal Symptom Rating Scale questionnaire, GSRS), compared to baseline
timeFrame: 4, 8 and 12 weeks
measure: Stool frequency in the week before each visit post- baseline, each compared to the week before baseline (V2)
timeFrame: 4, 8 and 12 weeks
measure: Physical activity parameters (Global Physical Activity Questionnaire, GPAQ), compared to baseline
timeFrame: 4, 8 and 12 weeks
Locations:
city: Berlin
country: Germany
facility: Analyze & Realize
city: Berlin
country: Germany
facility: Barbara Grube
city: Berlin
country: Germany
facility: Jörg Förstermann
Study officials:
References: