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

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Weight Loss
• Intervention / Treatment: Dietary supplement: ProbioSatys™; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10709
    • Barbara Grube
  • Berlin, Germany, 10369
    • Analyze & Realize
  • Berlin, Germany, 14059
    • Jörg Förstermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 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.
Experimental: ProbioSatys™	Dietary supplement: ProbioSatys™; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adverse events throughout the study		14 weeks
Blood pressure, compared to baseline		4, 8 and 12 weeks
Pulse rate, compared to baseline		4, 8 and 12 weeks
Safety laboratory parameters, compared to screening values (V1)	analysis of full blood count parameters (haemoglobin)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	analysis of full blood count parameters (haematocrit)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	analysis of full blood count parameters (thrombocytes)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	analysis of full blood count parameters (leucocytes)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (alanine transaminase)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (aspartate aminotransferase)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (gamma-glutamyltransferase)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (alkaline phosphatase)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (bilirubin)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (creatinine)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (urea)	14 weeks
Safety laboratory parameters, compared to screening values (V1)	liver and renal function parameters (uric acid)	14 weeks
Global evaluation of tolerability at V5 by subject and the investigator	"very good", "good", "moderate" and "poor"	12 weeks
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

Collaborators and Investigators

• Sponsor: TargEDys
• Collaborators: Analyze & Realize

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2018
• Primary Completion (Actual): November 28, 2019
• Study Completion (Actual): November 28, 2019

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Microbiome; Microbiota; Overweight; Probiotics; Weight loss; Satiety; Food intake; Enterobacteriaceae; Glycemia; Glucose Metabolism; Appetite regulation; Gut-brain axis; Hafnia alvei; Molecular mimicry
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: TAR/006118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No