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

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Type 2 Diabetes; Obesity, Abdominal; Obesity, Visceral
• Intervention / Treatment: Dietary supplement: synbiotic; Dietary supplement: microcrystalline cellulose

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1010
    • Slimbiotics GmbH
• Germany
  • Kiel, Germany, 24118
    • Clinical Research Center Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

1. Subjects currently enrolled in another clinical study
2. Subjects having finished another clinical study within the last 4 weeks before inclusion
3. Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
4. Condition after implantation of a cardiac pacemaker or other active implants
5. Antidiabetic drugs except metformin
6. 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
7. History of hepatitis B, C, HIV
8. History of or present liver deficiency as defined by Quick < 70%
9. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics containing supplements etc.)
10. Major cognitive or psychiatric disorders
11. Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
12. Simultaneous study participation by members of the same household
13. Pregnancy and lactation
14. Any diet to lose body weight
15. Eating disorders or vegan diet
16. Anorexic drugs and laxatives
17. Present drug abuse or alcoholism
18. Legal incapacity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: synbiotic; synbiotic consisting of three different strains of Lactobacillus fermentum + acacia gum (gum arabic)	Dietary supplement: synbiotic; 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
Placebo Comparator: microcrystalline cellulose	Dietary supplement: microcrystalline cellulose; Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BFM	Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; verum versus placebo group)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Glycated Hemoglobin	12 weeks
HOMA-IR	HOMA-IR (Homeostasis Model Assessment (HOMA)-IR = glucose [mmol/L] x insulin [µU/ml]/22,5) as parameter for insulin resistance	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
WC	Waist Circumference	12 weeks
WHtR	waist-to-height ratio	12 weeks

Collaborators and Investigators

• Sponsor: Slimbiotics GmbH
• Collaborators: Clinical Research Center Kiel GmbH
• Investigators: Principal Investigator: Christiane Laue, Dr. med., Clinical Research Center Kiel

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: diabetes; synbiotic; metabolic syndrome; body fat mass
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome; Obesity, Abdominal
• Other Study ID Numbers: Slim-LfX- 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No