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

Not Applicable

Completed

• Conditions: Weight Loss; Overweight
• Interventions: Dietary Supplement: ProbioSatys™; Other: Placebo

• Registration Number: NCT03657186
• Lead Sponsor: TargEDys

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.

Study Timeline

• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-30
• Study Start: 2018-08-31
• Study First Posted: 2018-09-04
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProbioSatys™	ProbioSatys™	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")	12 weeks

Secondary Outcome Measures

Name	Time	Method
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
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)	4, 8 and 12 weeks	continuous line between two endpoints: not saturated at all \& fully saturated

Trial Locations

Locations (3)

Analyze & Realize; 🇩🇪 Berlin, Germany

Barbara Grube; 🇩🇪 Berlin, Germany

Jörg Förstermann; 🇩🇪 Berlin, Germany