An interventional study of Sugar-Based Synbiotic Product and Inulin-Containing Sugar Product in Overweight Adults, sponsored by Federico II University. Enrolling by invitation at 1 site in Italy. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
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.
3,599 studies on the registry are indexed under Overweight; 852 are open to participants now.
This study's planned enrollment of 20 is below the median of 78 across 3,120 interventional studies indexed under Overweight.
Browse Overweight studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants consume two 5-g sachets of functional synbiotic sugar per day for 4 weeks. 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. The total daily dose is 10 g of functional sugar and 1 × 10⁹ CFU of Bacillus coagulans BC30™.
Dietary Supplement: Sugar-Based Synbiotic Product
Participants consume two 4.4-g sachets of the active comparator sugar per day for 4 weeks. Each sachet contains 1.4 g of inulin and 3 g of sucrose but no Bacillus coagulans BC30™ spores.
Dietary Supplement: Inulin-Containing Sugar 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.
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.
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
Plan to share: No
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