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CompletedNCT03657186Updated Mar 11, 2020

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

An interventional study of ProbioSatys™ and Placebo in Overweight and Weight Loss, sponsored by TargEDys. Completed at 3 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-11.

Sponsored by TargEDys · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 236 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

This is the only study on the registry with TargEDys as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
236 participants (actual)

Study arms

  • Experimental
    ProbioSatys™

    Dietary Supplement: ProbioSatys™

  • Placebo comparator
    Placebo

    Other: Placebo

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.

06

What researchers measure

Primary outcomes

  1. Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")

    Time frame: 12 weeks

Secondary outcomes

  1. Body weight change (in kg), compared to baseline (V2)

    Time frame: 4, 8 and 12 weeks

  2. Body weight change (%), compared to baseline (V2)

    Time frame: 4, 8 and 12 weeks

  3. Body weight (in kg )

    Time frame: 4, 8 and 12 weeks

  4. Proportion of subjects who lost at least 3% of baseline body weight (="3% responders")

    Time frame: 4 and 8 weeks

  5. Proportion of subjects who lost at least 5% of baseline body weight (="5% responders")

    Time frame: 4, 8 and 12 weeks

  6. Body fat mass assessed per bioelectrical impedance analysis (BIA), compared to baseline

    Time frame: 4, 8 and 12 weeks

  7. Body fat free mass assessed per bioelectrical impedance analysis (BIA), compared to baseline

    Time frame: 4, 8 and 12 weeks

  8. Waist circumference, compared to baseline

    Time frame: 4, 8 and 12 weeks

  9. Hip circumference, compared to baseline

    Time frame: 4, 8 and 12 weeks

  10. Lipid metabolism parameters (total cholesterol), compared to screening values (V1)

    Time frame: 14 weeks

  11. Lipid metabolism parameters (high density lipid cholesterol), compared to screening values (V1)

    Time frame: 14 weeks

  12. Lipid metabolism parameters (low density lipid cholesterol), compared to screening values (V1)

    Time frame: 14 weeks

  13. Fasting glucose, compared to screening values (V1)

    Time frame: 14 weeks

  14. Glycated haemoglobin (HbA1c), compared to screening values (V1)

    Time frame: 14 weeks

  15. 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

    Time frame: 4, 8 and 12 weeks

  16. 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

    Time frame: 4, 8 and 12 weeks

  17. 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"

    Time frame: 4, 8 and 12 weeks

  18. General well-being parameters (Impact of Weight on Quality of Life-Lite, IWQOL-LITE), compared to baseline

    Time frame: 4, 8 and 12 weeks

  19. Global evaluation of benefit at V5 by subject and the investigator

    "very good", "good", "moderate" and "poor"

    Time frame: 12 weeks

Other outcomes

  1. Assessment of adverse events throughout the study

    Time frame: 14 weeks

  2. Blood pressure, compared to baseline

    Time frame: 4, 8 and 12 weeks

  3. Pulse rate, compared to baseline

    Time frame: 4, 8 and 12 weeks

  4. Safety laboratory parameters, compared to screening values (V1)

    analysis of full blood count parameters (haemoglobin)

    Time frame: 14 weeks

  5. Safety laboratory parameters, compared to screening values (V1)

    analysis of full blood count parameters (haematocrit)

    Time frame: 14 weeks

  6. Safety laboratory parameters, compared to screening values (V1)

    analysis of full blood count parameters (thrombocytes)

    Time frame: 14 weeks

  7. Safety laboratory parameters, compared to screening values (V1)

    analysis of full blood count parameters (leucocytes)

    Time frame: 14 weeks

  8. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (alanine transaminase)

    Time frame: 14 weeks

  9. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (aspartate aminotransferase)

    Time frame: 14 weeks

  10. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (gamma-glutamyltransferase)

    Time frame: 14 weeks

  11. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (alkaline phosphatase)

    Time frame: 14 weeks

  12. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (bilirubin)

    Time frame: 14 weeks

  13. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (creatinine)

    Time frame: 14 weeks

  14. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (urea)

    Time frame: 14 weeks

  15. Safety laboratory parameters, compared to screening values (V1)

    liver and renal function parameters (uric acid)

    Time frame: 14 weeks

  16. Global evaluation of tolerability at V5 by subject and the investigator

    "very good", "good", "moderate" and "poor"

    Time frame: 12 weeks

  17. Gastrointestinal tolerability parameters (Gastrointestinal Symptom Rating Scale questionnaire, GSRS), compared to baseline

    Time frame: 4, 8 and 12 weeks

  18. Stool frequency in the week before each visit post- baseline, each compared to the week before baseline (V2)

    Time frame: 4, 8 and 12 weeks

  19. Physical activity parameters (Global Physical Activity Questionnaire, GPAQ), compared to baseline

    Time frame: 4, 8 and 12 weeks

07

Study locations

3 sites
  • Analyze & Realize
    Berlin, 10369, Germany
  • Barbara Grube
    Berlin, 10709, Germany
  • Jörg Förstermann
    Berlin, 14059, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03657186
Lead sponsor
TargEDys
Collaborators
Analyze & Realize
Responsible party
Sponsor
First posted
Sep 4, 2018
Start date
Aug 31, 2018
Primary completion
Nov 28, 2019
Completion
Nov 28, 2019
Last update
Mar 11, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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