Clinical trial

Effects of a Sugar-Based Synbiotic Product on Cardiometabolic and Intestinal Health (SUGAR-SYN BC3O)

Invitation only · Not applicable · 1 countries · Registry ID NCT07806383

Invitation onlyNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 70 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight Adults

Full registry criteria

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

Treatments and study arms

Sugar-Based Synbiotic Product

Dietary Supplement

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.

Inulin-Containing Sugar Product

Dietary Supplement

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.

Primary outcomes

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.

Study locations

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Federico II University🇮🇹 Naples, Italy

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