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

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ClinicalTrials.gov Identifier: NCT03657186
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Analyze & Realize
Information provided by (Responsible Party):
TargEDys

Tracking Information
First Submitted Date  ICMJE August 2, 2018
First Posted Date  ICMJE September 4, 2018
Last Update Posted Date March 11, 2020
Actual Study Start Date  ICMJE August 31, 2018
Actual Primary Completion Date November 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Proportion of subjects who lost at least 3% of baseline body weight (="3% responders") [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Body weight change (in kg), compared to baseline (V2) [ Time Frame: 4, 8 and 12 weeks ]
  • Body weight change (%), compared to baseline (V2) [ Time Frame: 4, 8 and 12 weeks ]
  • Body weight (in kg ) [ Time Frame: 4, 8 and 12 weeks ]
  • Proportion of subjects who lost at least 3% of baseline body weight (="3% responders") [ Time Frame: 4 and 8 weeks ]
  • Proportion of subjects who lost at least 5% of baseline body weight (="5% responders") [ Time Frame: 4, 8 and 12 weeks ]
  • Body fat mass assessed per bioelectrical impedance analysis (BIA), compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • Body fat free mass assessed per bioelectrical impedance analysis (BIA), compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • Waist circumference, compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • Hip circumference, compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • Lipid metabolism parameters (total cholesterol), compared to screening values (V1) [ Time Frame: 14 weeks ]
  • Lipid metabolism parameters (high density lipid cholesterol), compared to screening values (V1) [ Time Frame: 14 weeks ]
  • Lipid metabolism parameters (low density lipid cholesterol), compared to screening values (V1) [ Time Frame: 14 weeks ]
  • Fasting glucose, compared to screening values (V1) [ Time Frame: 14 weeks ]
  • Glycated haemoglobin (HbA1c), compared to screening values (V1) [ Time Frame: 14 weeks ]
  • Evaluation of the overall feeling of satiety compared to baseline by using visual analogue scales (VAS) [ Time Frame: 4, 8 and 12 weeks ]
    continuous line between two endpoints: not saturated at all & fully saturated
  • Evaluation of the overall feeling of fullness compared to baseline by using visual analogue scales (VAS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 4, 8 and 12 weeks ]
  • Global evaluation of benefit at V5 by subject and the investigator [ Time Frame: 12 weeks ]
    "very good", "good", "moderate" and "poor"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2018)
  • Assessment of adverse events throughout the study [ Time Frame: 14 weeks ]
  • Blood pressure, compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • Pulse rate, compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    analysis of full blood count parameters (haemoglobin)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    analysis of full blood count parameters (haematocrit)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    analysis of full blood count parameters (thrombocytes)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    analysis of full blood count parameters (leucocytes)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (alanine transaminase)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (aspartate aminotransferase)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (gamma-glutamyltransferase)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (alkaline phosphatase)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (bilirubin)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (creatinine)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (urea)
  • Safety laboratory parameters, compared to screening values (V1) [ Time Frame: 14 weeks ]
    liver and renal function parameters (uric acid)
  • Global evaluation of tolerability at V5 by subject and the investigator [ Time Frame: 12 weeks ]
    "very good", "good", "moderate" and "poor"
  • Gastrointestinal tolerability parameters (Gastrointestinal Symptom Rating Scale questionnaire, GSRS), compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
  • 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 ]
  • Physical activity parameters (Global Physical Activity Questionnaire, GPAQ), compared to baseline [ Time Frame: 4, 8 and 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
Official Title  ICMJE Double-blind, Randomised, Placebo-controlled Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight
  • Weight Loss
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: ProbioSatys™
    Intervention: Dietary Supplement: ProbioSatys™
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
236
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 28, 2019
Actual Primary Completion Date November 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657186
Other Study ID Numbers  ICMJE TAR/006118
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TargEDys
Study Sponsor  ICMJE TargEDys
Collaborators  ICMJE Analyze & Realize
Investigators  ICMJE Not Provided
PRS Account TargEDys
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP