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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754464
• Other study ID #: Slim-LfX- 2020
• Status: Completed
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2022
• Source: Slimbiotics GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 31, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Austria	Slimbiotics GmbH	Vienna
Germany	Clinical Research Center Kiel	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Slimbiotics GmbH	Clinical Research Center Kiel GmbH

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	WC	Waist Circumference	12 weeks
Other	WHtR	waist-to-height ratio	12 weeks
Primary	BFM	Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; verum versus placebo group)	12 weeks
Secondary	HbA1c	Glycated Hemoglobin	12 weeks
Secondary	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