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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
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.
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.
Federico II University
Naples, Italy
Difference Between Interventions in the Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)
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.
Time frame: baseline and after 4 week of each intervention
Difference Between Interventions in the Change in interleukin 6 (IL-6)
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
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in interleukin 10 (IL-10)
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
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in TNF-alfa
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
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in plasma glucose
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
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in plasma insulin
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
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in HOMA-IR index
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.
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum lipids
Fasting serum triglycerides, totol cholesterol, and HDL cholesterol are measured at baseline and after 4 weeks of each intervention using an immunoenzymatic methods
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)
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)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)
Fasting serum SCFA (acetate, propionate, butyrate) are measured at baseline and after 4 weeks of each intervention by gas-cromatography with flame ionization detection (GC-FID)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum zonulin
Fasting serum zonulin is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in ng/ml
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting lipopolysaccharide (LPS)
Fasting serum LPS is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in pg/ml
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the gut microbiota composition
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.
Time frame: baseline and after 4 weeks of each itervention
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