Overweight Adults
Conditions
Keywords
Spore-forming probiotic, Overweight, Functional sugar, Subclinical inflammation, Bacillus coagulans BC30™, Cardiometabolic risk, Gut microbiota
Brief summary
This randomized, double-blind, controlled, crossover study investigates the effects of a sugar-based synbiotic product containing inulin and Bacillus coagulans BC30™ spores in healthy overweight individuals. Twenty participants complete a 2-week run-in period and two 4-week intervention periods separated by a 4-week washout. During each intervention period, participants consume two sachets per day of either the synbiotic sugar product, providing 1 × 10⁹ CFU/day of Bacillus coagulans BC30™, or a matched control sugar product containing inulin without probiotic spores. The primary outcome is the change in fasting markers of subclinical inflammation, including high-sensitivity C-reactive protein, interleukin-6, interleukin-10 and tumor necrosis factor-alpha. Secondary outcomes include fasting glucose and insulin, fasting lipids, intestinal permeability, short-chain fatty acids, body composition, gastrointestinal symptoms, stool frequency and consistency, and gut microbiota composition. Participants maintain their usual diet and lifestyle throughout the study.
Interventions
DIETARY_SUPPLEMENTSugar-Based Synbiotic Product
Participants consume two 5-g sachets of the sugar-based synbiotic product daily for 4 weeks, either before or after the comparator intervention according to the randomized treatment sequence. The two intervention periods are separated by a 4-week washout. Each sachet contains 1.4 g of inulin, 3 g of sucrose, and 0.6 g of Bacillus coagulans BC30™ spores (GBI-30, 6086), providing 5 × 10⁸ CFU per sachet and a total daily dose of 1 × 10⁹ CFU.
DIETARY_SUPPLEMENTInulin-Containing Sugar Product
Participants consume two 4.4-g sachets of the comparator sugar product daily for 4 weeks, either before or after the synbiotic intervention according to the randomized treatment sequence. The two intervention periods are separated by a 4-week washout. Each sachet contains 1.4 g of inulin and 3 g of sucrose but no Bacillus coagulans BC30™ spores.
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI): 25-29.9 kg/m2
Exclusion criteria
* Diabetes * Cardiovascular events (myocardial infarction and/or stroke) within the previous 6 months * Renal impairment (serum creatinine \>1.5 mg/dL) or hepatic impairment (ALT and/or AST levels more than twice the upper limit of normal) * Anemia (hemoglobin \<12 g/dL) * Treatment with lipid-lowering or anti-inflammatory medications * Use of antibiotics, probiotics, or prebiotics within the previous 3 months * Regular use of dietary supplements * Any other acute or chronic clinical condition that could significantly affect the study results and/or make study participation a health risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Interventions in the Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP) | baseline and after 4 week of each intervention | Fasting serum hs-CRP is measured at baseline and after 4 weeks of each intervention. Serum hs-CRP concentrations are determined using an immunoturbidimetric method and expressed in mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Interventions in the Change in interleukin 6 (IL-6) | baseline and after 4 weeks of each itervention | Fasting serum IL-6 is measured at baseline and after 4 weeks of each intervention. Serum IL-6 concentrations are determined using an ELISA method and expressed as pg/ml |
| Difference Between Interventions in the Change in interleukin 10 (IL-10) | baseline and after 4 weeks of each itervention | Fasting serum IL-10 is measured at baseline and after 4 weeks of each intervention. Serum IL-6 concentrations are determined using an ELISA method and expressed as pg/ml |
| Difference Between Interventions in the Change in TNF-alfa | baseline and after 4 weeks of each itervention | Fasting serum TNF-alfa is measured at baseline and after 4 weeks of each intervention. Serum TNF-alfa concentrations are determined using an ELISA method and expressed as pg/ml |
| Difference Between Interventions in the Change in plasma glucose | baseline and after 4 weeks of each itervention | Fasting plasma glucose is measured at baseline and after 4 weeks of each intervention. Plasma glucose concentrations are determined using an immunoenzymatic method and expressed as mg/dl |
| Difference Between Interventions in the Change in plasma insulin | baseline and after 4 weeks of each itervention | Fasting plasma insulin is measured at baseline and after 4 weeks of each intervention. Plasma insulin concentrations are determined using an ELISA method and expressed as μU/ml |
| Difference Between Interventions in the Change in HOMA-IR index | baseline and after 4 weeks of each itervention | HOMA-IR is calculated at baseline and after 4 weeks of each intervention using the following formula: fasting plasma glucose (mg/dL) × fasting serum insulin (µU/mL) / 405. Higher HOMA-IR values indicate greater insulin resistance. |
| Difference Between Interventions in the fasting serum lipids | baseline and after 4 weeks of each itervention | Fasting serum triglycerides, totol cholesterol, and HDL cholesterol are measured at baseline and after 4 weeks of each intervention using an immunoenzymatic methods |
| Difference Between Interventions in the fasting serum short chain fatty acids (SCFA) | baseline and after 4 weeks of each itervention | Fasting serum SCFA (acetate, propionate, butyrate) are measured at baseline and after 4 weeks of each intervention by gas-cromatography with flame ionization detetctio (GC-FID) |
| Difference Between Interventions in the fasting serum zonulin | baseline and after 4 weeks of each itervention | Fasting serum zonulin is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in ng/ml |
| Difference Between Interventions in the fasting lipopolysaccharide (LPS) | baseline and after 4 weeks of each itervention | Fasting serum LPS is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in pg/ml |
| Difference Between Interventions in the gut microbiota composition | baseline and after 4 weeks of each itervention | Fecal samples are collected at baseline and after 4 weeks of each intervention. Gut microbial community structure is analyzed using 16S rRNA gene sequencing and shotgun metagenomic sequencing to assess changes in taxonomic composition and functional profiles. |
Countries
Italy
Outcome results
None listed