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

Condition(s) studied

Investigational drug(s) / intervention(s)

Sugar-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.

Inulin-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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

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