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

Evaluation of the Effects of Consuming a Sugar-based Synbiotic Product Containing Bacillus Coagulans BC30™ Spores on Subclinical Inflammation, Cardiometabolic Risk, and Intestinal Function in Healthy Individuals (SUGAR-SYN BC30 Study)

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.

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