AzTrials
AzTrials

OverweightNCT03657186

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

A study testing ProbioSatys™ in people with Overweight and Weight Loss, run by TargEDys at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Overweight, Weight Loss
What is being tested?
ProbioSatys™
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
236 participants
Where
3 sitesGermany
Study dates
31 Aug 2018to 28 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 to 65 years old males and females
  • Overweight (Body Mass Index, BMI: 25 kg/m2 - 29.9 kg/m2)
  • Generally in good health
  • Desire to lose weight
  • Regularly consuming 3 main meals/day (breakfast, lunch, dinner)
  • Readiness to comply with study procedures, in particular:
Show all 21Show fewer
  • 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
  • Stable body weight in the last 3 months prior to V1 (≤5% self-reported change)
  • Stable concomitant medications (if any) for at least last 3 months prior to V1
  • 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):
  • No change in body weight or reduction up to 3 kg (compared to V1)
  • Adequately completed subject diary
  • Readiness and ability to comply with study requirements
  • Relevant inclusion and exclusion criteria met

Who cannot join

  • Known allergy/sensitivity to any components of the investigational product
  • Pathological electrocardiogram (ECG) at V1
  • 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
Show all 28Show fewer
  • 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
  • History and/or presence of eating disorders like bulimia, anorexia nervosa, binge-eating as per investigator's judgement
  • Any electronic medical implant
  • 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)
  • 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
  • Diet/weight loss programs within the last 3 months prior to V1 and during the study
  • 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)
  • Vegetarian, vegan or other restrictive diet
  • Pregnancy or nursing
  • History of or current abuse of drugs, alcohol or medication
  • Inability to comply with study procedures
  • Participation in another study during the last 30 days prior to V1
  • Any other reason deemed suitable for exclusion, per investigator's judgment

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Analyze & Realize

    Berlin, 10369

  • Barbara Grube

    Berlin, 10709

  • Jörg Förstermann

    Berlin, 14059

Other trials in Germany

About this study

Official title: 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.

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.

Being tested
ProbioSatys™, Placebo
Keywords
Probiotics, Microbiome, Microbiota, Hafnia alvei, Overweight, Food intake, Appetite regulation, Satiety, Weight loss, Glucose Metabolism, Glycemia, Enterobacteriaceae, Gut-brain axis, Molecular mimicry
Medical subject headings
Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioSatys™Dietary supplement

    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.

  • PlaceboOther

    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 groups in NCT03657186
Study groupRoleWhat they receive
ProbioSatys™ExperimentalNot described
Receives: Dietary Supplement: ProbioSatys™
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

Secondary outcomes (19)

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

    Measured: 4, 8 and 12 weeks

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

    Measured: 4, 8 and 12 weeks

  3. Body weight (in kg )

    Measured: 4, 8 and 12 weeks

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

    Measured: 4 and 8 weeks

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

    Measured: 4, 8 and 12 weeks

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

    Measured: 4, 8 and 12 weeks

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

    Measured: 4, 8 and 12 weeks

  8. Waist circumference, compared to baseline

    Measured: 4, 8 and 12 weeks

  9. Hip circumference, compared to baseline

    Measured: 4, 8 and 12 weeks

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

    Measured: 14 weeks

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

    Measured: 14 weeks

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

    Measured: 14 weeks

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

    Measured: 14 weeks

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

    Measured: 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

    Measured: 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

    Measured: 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"

    Measured: 4, 8 and 12 weeks

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

    Measured: 4, 8 and 12 weeks

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

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start31 Aug 2018
  3. Primary completion28 Nov 2019
  4. Study completion28 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03657186
Sponsor's protocol ID
TAR/006118
Status last verified
Mar 2020
First submitted
2 Aug 2018
Last updated
11 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ProbioSatys™ in people with Overweight and Weight Loss, run by TargEDys at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who lost at least 3% of baseline body weight (="3% responders") (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03657186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in