- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04754464
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: synbiotic
synbiotic consisting of three different strains of Lactobacillus fermentum + acacia gum (gum arabic)
|
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
|
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
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
Glycated Hemoglobin
|
12 weeks
|
HOMA-IR
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
Waist Circumference
|
12 weeks
|
WHtR
Time Frame: 12 weeks
|
waist-to-height ratio
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christiane Laue, Dr. med., Clinical Research Center Kiel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Slim-LfX- 2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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