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

NCT03657186 | Completed

• 1 other identifier: TAR/006118
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (19)

• 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

Other Outcomes (19)

• 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

Study Arms (2)

ProbioSatys™

EXPERIMENTAL

Dietary Supplement: ProbioSatys™

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

ProbioSatys™

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• TargEDys: lead
• Analyze & Realize: collaborator

Study Sites (3)

Analyze & Realize

Berlin, 10369, Germany

Location

Barbara Grube

Berlin, 10709, Germany

Location

Jörg Förstermann

Berlin, 14059, Germany

Location

MeSH Terms

Conditions

Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: September 4, 2018
• Study Start: August 31, 2018
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)