NCT04754464

Brief Summary

In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors for CVD and diabetes in overweight type 2 diabetics is investigated.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2020

Geographic Reach
2 countries

2 active sites

Status
completed

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

May 13, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.3 years

First QC Date

February 10, 2021

Last Update Submit

May 30, 2022

Conditions

Type 2 DiabetesMetabolic SyndromeObesity, AbdominalObesity, Visceral

Keywords

synbioticbody fat massmetabolic syndromediabetes

Outcome Measures

Primary Outcomes (1)

  • BFM

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

    12 weeks

Secondary Outcomes (2)

  • HbA1c

    12 weeks

  • HOMA-IR

    12 weeks

Other Outcomes (2)

  • WC

    12 weeks

  • WHtR

    12 weeks

Study Arms (2)

synbiotic

ACTIVE COMPARATOR

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

Dietary Supplement: synbiotic

microcrystalline cellulose

PLACEBO COMPARATOR

microcrystalline cellulose

Dietary Supplement: microcrystalline cellulose

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 water

synbiotic
microcrystalline celluloseDIETARY_SUPPLEMENT

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

microcrystalline cellulose

Eligibility Criteria

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

You may qualify if:

  • Overweight or obese (BMI ≥ 25)
  • Type 2 diabetes
  • 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
  • Antidiabetic drugs except metformin
  • History of hepatitis B, C, HIV
  • 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 etc.)
  • 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
  • Any diet to lose body weight
  • Eating disorders or vegan diet
  • Anorexic drugs and laxatives
  • Present drug abuse or alcoholism
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Slimbiotics GmbH

Vienna, 1010, Austria

Location

Clinical Research Center Kiel

Kiel, 24118, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Metabolic SyndromeObesity, AbdominalDiabetes Mellitus

Interventions

Synbioticsmicrocrystalline cellulose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • Christiane Laue, Dr. med.

    Clinical Research Center Kiel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo products are identical with verum 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

February 10, 2021

First Posted

February 15, 2021

Study Start

May 13, 2020

Primary Completion

September 15, 2021

Study Completion

May 31, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)AU(1)