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

• Sponsor: Slimbiotics GmbH (Other)
• Overall Status: Completed
• CT.gov ID: NCT04754464
• Collaborator: Clinical Research Center Kiel GmbH (Other)
• Enrollment: 120
• Locations: 2
• Arms: 2
• Actual Duration (Months): 24.6
• Patients Per Site: 60
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes; Metabolic Syndrome; Obesity, Abdominal; Obesity, Visceral	Dietary Supplement: synbiotic; Dietary Supplement: microcrystalline cellulose	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised, controlled, double-blindRandomised, controlled, double-blind
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Placebo products are identical with verum in smell, flavour, color, texture, appearance, packaging (sachets) and labelling.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 13, 2020
• Actual Primary Completion Date: Sep 15, 2021
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. BFM [12 weeks]

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

Secondary Outcome Measures

1. HbA1c [12 weeks]

   Glycated Hemoglobin

2. HOMA-IR [12 weeks]

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

Other Outcome Measures

1. WC [12 weeks]

   Waist Circumference

2. WHtR [12 weeks]

   waist-to-height ratio

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. acacia gum)

1. Condition after implantation of a cardiac pacemaker or other active implants

2. Antidiabetic drugs except metformin

3. 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

4. History of hepatitis B, C, HIV

5. History of or present liver deficiency as defined by Quick < 70%

6. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics containing supplements etc.)

7. Major cognitive or psychiatric disorders

8. Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations

9. Simultaneous study participation by members of the same household

10. Pregnancy and lactation

11. Any diet to lose body weight

12. Eating disorders or vegan diet

13. Anorexic drugs and laxatives

14. Present drug abuse or alcoholism

15. Legal incapacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Slimbiotics GmbH	Vienna		Austria	1010
2	Clinical Research Center Kiel	Kiel		Germany	24118

Sponsors and Collaborators

• Slimbiotics GmbH
• Clinical Research Center Kiel GmbH

Investigators

• Principal Investigator: Christiane Laue, Dr. med., Clinical Research Center Kiel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Slimbiotics GmbH
• ClinicalTrials.gov Identifier: NCT04754464
• Other Study ID Numbers: Slim-LfX- 2020
• First Posted: Feb 15, 2021
• Last Update Posted: Jun 1, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Slimbiotics GmbH: synbiotic; body fat mass; metabolic syndrome; diabetes
• Additional relevant MeSH terms: Obesity; Metabolic Syndrome; Obesity, Abdominal; Syndrome

Study Results

No Results Posted as of Jun 1, 2022