NCT05405205

Brief Summary

In this placebo-controlled trial the effect of a synbiotic consisting of three different strains of Lactobacillus fermentum and acacia gum (gum arabic) was compared with a probiotic formulation containing identical strains on body fat mass, body weight management, traits of metabolic syndrome and gut permeability in individuals who are abdominally overweight.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 6, 2022

Status Verified

May 1, 2022

Enrollment Period

12 months

First QC Date

May 31, 2022

Last Update Submit

May 31, 2022

Conditions

Weight, Body

Keywords

synbioticprobioticbody fat massabdominal overweight

Outcome Measures

Primary Outcomes (1)

  • Body Fat Mass

    Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; synbiotic versus placebo

    12 weeks

Secondary Outcomes (1)

  • Visceral Adiposity Index

    12 weeks

Other Outcomes (3)

  • HOMA-IR

    12 weeks

  • MSX-index

    12 weeks

  • Sagittal abdominal diameter (SAD)

    12 weeks

Study Arms (3)

synbiotic

EXPERIMENTAL

synbiotic consisting of three different strains of Lactobacillus fermentum + acacia gum (gum arabic)

Dietary Supplement: synbiotic

probiotic

EXPERIMENTAL

probiotic consisting of the identical three different strains of Lactobacillus fermentum

Dietary Supplement: probiotic

placebo

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: placebo

Interventions

synbioticDIETARY_SUPPLEMENT

Consumption of 6 g powder consisting of the strains Lactobacillus fermentum K7-Lb1, L. fermentum K8- Lb1, L. fermentum K11-Lb3, acacia gum (gum arabic), maltodextrin, sucralose and flavour twice a day resolved in drinking water

synbiotic
probioticDIETARY_SUPPLEMENT

Consumption of 6 g powder consisting of the strains Lactobacillus fermentum K7-Lb1, L. fermentum K8- Lb1, L. fermentum K11-Lb3, maltodextrin, sucralose and flavour twice a day resolved in drinking water

probiotic
placeboDIETARY_SUPPLEMENT

Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in drinking water

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight or obese (BMI ≥ 25)
  • Elevated waist circumference (\>94cm and \>80cm (for European men and women, respectively)
  • Age ≥ 18
  • Written informed consent

You may not qualify if:

  • Subjects currently enrolled in another clinical study
  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clincal Research Center Kiel GmbH

Kiel, Schleswig-Holstein, 24118, Germany

Location

MeSH Terms

Conditions

Body Weight

Interventions

SynbioticsProbiotics

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Helmut Essl

    Slimbiotics GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All three products are identical in smell, flavour, color, texture, appearance, packaging (sachets) and labelling.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised, controlled, double-blind
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 6, 2022

Study Start

June 8, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

June 6, 2022

Record last verified: 2022-05

Locations

DE(1)