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NCT Number: NCT07806383

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

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.

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Key information

Conditions

Overweight Adults Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Difference Between Interventions in the Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)

    Time frame: 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.

Secondary outcomes

  1. Difference Between Interventions in the Change in interleukin 6 (IL-6)

    Time frame: baseline and after 4 weeks of each itervention

    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

  2. Difference Between Interventions in the Change in interleukin 10 (IL-10)

    Time frame: baseline and after 4 weeks of each itervention

    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

  3. Difference Between Interventions in the Change in TNF-alfa

    Time frame: baseline and after 4 weeks of each itervention

    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

  4. Difference Between Interventions in the Change in plasma glucose

    Time frame: baseline and after 4 weeks of each itervention

    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

  5. Difference Between Interventions in the Change in plasma insulin

    Time frame: baseline and after 4 weeks of each itervention

    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

  6. Difference Between Interventions in the Change in HOMA-IR index

    Time frame: baseline and after 4 weeks of each itervention

    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.

  7. Difference Between Interventions in the fasting serum lipids

    Time frame: baseline and after 4 weeks of each itervention

    Fasting serum triglycerides, totol cholesterol, and HDL cholesterol are measured at baseline and after 4 weeks of each intervention using an immunoenzymatic methods

  8. Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)

    Time frame: baseline and after 4 weeks of each itervention

    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)

  9. Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)

    Time frame: baseline and after 4 weeks of each itervention

    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)

  10. Difference Between Interventions in the fasting serum zonulin

    Time frame: baseline and after 4 weeks of each itervention

    Fasting serum zonulin is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in ng/ml

  11. Difference Between Interventions in the fasting lipopolysaccharide (LPS)

    Time frame: baseline and after 4 weeks of each itervention

    Fasting serum LPS is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in pg/ml

  12. Difference Between Interventions in the gut microbiota composition

    Time frame: baseline and after 4 weeks of each itervention

    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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study 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)

Acronym: SUGAR-SYN BC3O

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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