Metabolic Endotoxemia, Metabolic Syndrome
Conditions
Brief summary
The purpose of this study is to determine whether probiotic treatment of overweight volunteers consuming high fat diet is able to reduce plasma lipopolysaccharide concentration.
Interventions
DIETARY_SUPPLEMENTProbiotic bacterium Bifidobacterium lactis
Probiotic placebo controlled intervention
Sponsors
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Body mass index ≥ 27 kg/m2; above 18 years of age * Used to eat high fat diet (more than 40% of total energy intake)
Exclusion criteria
* Treated cardiovascular risk factors, treated hypertension, treated dyslipidemia, treated diabetes; Known diabetes, hypertension, dyslipidemia * Severe illnesses * Artificial heart valve * Immunosuppression * Regular consumption of probiotics * History of bariatric surgery * Consumption or wish to consume Orlistat * Participation in other research * Pregnancy or wishing/trying to get pregnant * Inability to follow protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of plasma endotoxin (plasma levels of lipopolysaccharides) in the volunteers before and after the 12 week intervention | 12 weeks | Quantitative, kinetic assay for the detection of gram negative bacterial endotoxin (lipopolysaccharide) is used to test whether the probiotic intervention can reduce plasma endotoxin levels (IU/ml) compared to the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volunteer waist perimeter before and after the 12 week intervention | 12 weeks | — |
| Insulin resistance (HOMA-IR index), glycemia, insulinemia and glycated hemoglobin in the volunteers before and after the 12 week intervention | 12 weeks | Insulin resistance (IR) will be quantified in the non-diabetic adults using the HOMA-IR index calculated as the product of fasting plasma insulin (in microunits per milliliter) and fasting plasma glucose (in millimoles per liter), divided by 22.5. Higher HOMA values indicate higher IR. Glycated haemoglobin is used as a biological measure indicator of blood glucose concentration over 3 months. |
| Brachial blood pressure of the volunteers before and after the 12 week intervention. | 12 weeks | — |
| Volunteer weight before and after the 12 week intervention. | 12 weeks | — |
| Serum inflammatory markers of volunteers before and after the 12 week intervention. | 12 weeks | IL-6 (Interleukin-6) level is measured by an immunoenzymatic method, sCD14 is measured using an immuno-enzymatic method, and C reactive protein (CRP) levels is measured by an immunonephelemetric method. |
| Intestinal microbiota composition measured from stool samples before and after the 12 week intervention. | 12 weeks | Stool samples are collected before and after the intervention and stored frozen until analysis. Bacterial DNA is extracted from the samples and relevant bacterial groups including genus Bifidobacterium, species Bifidobacterium animalis subsp. lactis, Enterobacteriaceae, Escherichia coli, Bacteroidetes and Lactobacillus are measures with quantitative real-time PCR. |
| Gut function questionaire as a measure of tolerability | Symptoms during last 6 days | Questionaire is used to assess the tolerability of the probiotic supplementation. Questionaire includes questions on frequency and severity of flatulence and bloating, occurence of diarhea, frequency of defecation, and texture of feces using a stool chart. |
| Blood lipids in the volunteers before and after the 12 week intervention. | 12 weeks | Plasma total cholesterol and triglycerides are measured by enzymatic methods. High-density lipoprotein (HDL) cholesterol is measured in the supernatant after sodium phosphotungstate/magnesium chloride precipitation. Low-density lipoprotein (LDL) cholesterol is determined by the Friedewald formula. |
Countries
France
Outcome results
None listed