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Search / Trial NCT05405205

Effect of Synbiotic L. Fermentum Strains on Body Fat Mass

Launched by SLIMBIOTICS GMBH · May 31, 2022

Trial Information

Current as of May 19, 2025

Unknown status

Keywords

Synbiotic Probiotic Body Fat Mass Abdominal Overweight

ClinConnect Summary

The effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat and liver steatosis were shown by several meta-analyses for the total variety, as described above. Some probiotic species/strains, however, seem to be more efficacious (Koutnikova et al., 2019). The lactobacilli used in this trial were selected for their anti-inflammatory properties and based on induction of defensins in enterocytes. Therefore, one may expect more pronounced effects of these strains on traits of the metabolic syndrome, which is driven by low grade inflammation, than those found in t...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Overweight or obese (BMI ≥ 25)
  • Elevated waist circumference (\>94cm and \>80cm (for European men and women, respectively)
  • Age ≥ 18
  • Written informed consent
  • Exclusion Criteria:
  • Subjects currently enrolled in another clinical study
  • Subjects having finished another clinical study within the last 4 weeks before inclusion
  • Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
  • Condition after implantation of a cardiac pacemaker or other active implants
  • Sulfonylurea treatment
  • Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
  • History of or present liver deficiency as defined by Quick \< 70%
  • Regular medical treatment including OTC, which may have impact on the study aims (e. g. probiotics containing supplements, laxatives, steroids etc.)
  • History of hepatitis B, C, HIV
  • Major cognitive or psychiatric disorders
  • Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
  • Simultaneous study participation by members of the same household
  • Pregnancy and lactation
  • Ascites as assessed by sonography
  • Any diet to lose body weight
  • Eating disorders or vegan diet
  • Anorexic drugs
  • Present drug abuse or alcoholism
  • Legal incapacity

About Slimbiotics Gmbh

Slimbiotics GmbH is an innovative clinical trial sponsor dedicated to advancing research in the field of microbiome health and weight management. With a focus on developing evidence-based solutions, the company leverages cutting-edge scientific methodologies to explore the interplay between gut microbiota and metabolic processes. Slimbiotics GmbH is committed to conducting rigorous clinical trials that adhere to the highest ethical and regulatory standards, aiming to deliver impactful findings that can enhance therapeutic options for individuals seeking to improve their health and well-being.

Locations

Kiel, Schleswig Holstein, Germany

Patients applied

0 patients applied

Trial Officials

Helmut Essl

Study Director

Slimbiotics GmbH

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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