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Clinical Study on the Effect of a Synbiotic on Body Fat Mass

Primary Purpose

Type 2 Diabetes, Metabolic Syndrome, Obesity, Abdominal

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

synbiotic

microcrystalline cellulose

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring synbiotic, body fat mass, metabolic syndrome, diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Overweight or obese (BMI ≥ 25)
Type 2 diabetes
Age ≥ 18
Written informed consent

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from enrollment into the study:

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
Antidiabetic drugs except metformin
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 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
Legal incapacity

Sites / Locations

Slimbiotics GmbH
Clinical Research Center Kiel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

synbiotic

microcrystalline cellulose

Arm Description

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

microcrystalline cellulose

Outcomes

Primary Outcome Measures

BFM

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

Secondary Outcome Measures

HbA1c

Glycated Hemoglobin

HOMA-IR

HOMA-IR (Homeostasis Model Assessment (HOMA)-IR = glucose [mmol/L] x insulin [µU/ml]/22,5) as parameter for insulin resistance

Full Information

NCT ID

NCT04754464

First Posted

February 10, 2021

Last Updated

May 30, 2022

Sponsor

Slimbiotics

Collaborators

Clinical Research Center Kiel GmbH

1. Study Identification

Unique Protocol Identification Number

NCT04754464

Brief Title

Clinical Study on the Effect of a Synbiotic on Body Fat Mass

Official Title

Randomised, Controlled, Double-blind Clinical Study on the Effect of a Synbiotic on Body Fat Mass, Weight Management, Metabolic Syndrome and Other Risk Factors for CVD and Diabetes, on Fecal Microbiota and Adverse Effects

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

May 13, 2020 (Actual)

Primary Completion Date

September 15, 2021 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Slimbiotics

Collaborators

Clinical Research Center Kiel GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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. 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 the meta-analyses for the whole variety of probiotics without discriminating species and strain specificity. The combination of these Lactobacillus strains with acacia gum is expected to enable even more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in the gut and, hence, are supposed to promote their propagation and, hence their effects. The dosage of 10 g/day acacia gum was demonstrated to be sufficient for enhancing fecal lactobacilli and bifidobacterial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Metabolic Syndrome, Obesity, Abdominal, Obesity, Visceral

Keywords

synbiotic, body fat mass, metabolic syndrome, diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomised, controlled, double-blind

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Placebo products are identical with verum in smell, flavour, color, texture, appearance, packaging (sachets) and labelling.

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

synbiotic

Arm Type

Active Comparator

Arm Description

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

Arm Title

microcrystalline cellulose

Arm Type

Placebo Comparator

Arm Description

microcrystalline cellulose

Intervention Type

Dietary Supplement

Intervention Name(s)

synbiotic

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

microcrystalline cellulose

Intervention Description

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

Primary Outcome Measure Information:

Title

BFM

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

HbA1c

Description

Glycated Hemoglobin

Time Frame

12 weeks

Title

HOMA-IR

Description

HOMA-IR (Homeostasis Model Assessment (HOMA)-IR = glucose [mmol/L] x insulin [µU/ml]/22,5) as parameter for insulin resistance

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Description

Waist Circumference

Time Frame

12 weeks

Title

WHtR

Description

waist-to-height ratio

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Overweight or obese (BMI ≥ 25) Type 2 diabetes Age ≥ 18 Written informed consent Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from enrollment into the study: 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 Antidiabetic drugs except metformin 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 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 Legal incapacity

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christiane Laue, Dr. med.

Organizational Affiliation

Clinical Research Center Kiel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Slimbiotics GmbH

City

Vienna

ZIP/Postal Code

1010

Country

Austria

Facility Name

Clinical Research Center Kiel

City

Kiel

ZIP/Postal Code

24118

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Study on the Effect of a Synbiotic on Body Fat Mass

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