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Effects of a Sugar-Based Synbiotic Product on Cardiometabolic and Intestinal Health (SUGAR-SYN BC3O)
Sponsor: Federico II University
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.
Official title: 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)
Key Details
Gender
All
Age Range
20 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-05-04
Completion Date
2027-03-01
Last Updated
2026-09-08
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Federico II University
Naples, Italy