Overweight AdultsSUGAR-SYN BC3ONCT07806383
Effects of a Sugar-Based Synbiotic Product on Cardiometabolic and Intestinal Health (SUGAR-SYN BC3O)
A study testing Sugar-Based Synbiotic Product and Inulin-Containing Sugar Product in people with Overweight Adults, run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight Adults
- What is being tested?
- Sugar-Based Synbiotic Product and Inulin-Containing Sugar Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 4 May 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI): 25-29.9 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this 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)
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.
- Conditions
- Overweight Adults
- Being tested
- Sugar-Based Synbiotic Product, Inulin-Containing Sugar Product
- Keywords
- Spore-forming probiotic, Overweight, Functional sugar, Subclinical inflammation, Bacillus coagulans BC30™, Cardiometabolic risk, Gut microbiota
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-Based Synbiotic ProductDietary 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 ProductDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Functional synbiotic sugar containing Bacillus coagulans BC30™ | Experimental | Participants consume two 5-g sachets of functional synbiotic sugar per day for 4 weeks. 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. The total daily dose is 10 g of functional sugar and 1 × 10⁹ CFU of Bacillus coagulans BC30™. Receives: Dietary Supplement: Sugar-Based Synbiotic Product |
| Matched sugar product without Bacillus coagulans BC30™ spores | Active comparator | Participants consume two 4.4-g sachets of the active comparator sugar per day for 4 weeks. Each sachet contains 1.4 g of inulin and 3 g of sucrose but no Bacillus coagulans BC30™ spores. Receives: Dietary Supplement: Inulin-Containing Sugar Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Between Interventions in the Change in Serum High-Sensitivity C-Reactive Protein (hs-CRP)
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.
Measured: baseline and after 4 week of each intervention
Secondary outcomes (12)
Difference Between Interventions in the Change in interleukin 6 (IL-6)
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
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in interleukin 10 (IL-10)
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
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in TNF-alfa
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
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in plasma glucose
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
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in plasma insulin
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
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in HOMA-IR index
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.
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum lipids
Fasting serum triglycerides, totol cholesterol, and HDL cholesterol are measured at baseline and after 4 weeks of each intervention using an immunoenzymatic methods
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)
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)
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)
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)
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum zonulin
Fasting serum zonulin is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in ng/ml
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting lipopolysaccharide (LPS)
Fasting serum LPS is measured at baseline and after 4 weeks of each intervention by ELISA method and expressed in pg/ml
Measured: baseline and after 4 weeks of each itervention
Difference Between Interventions in the gut microbiota composition
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.
Measured: baseline and after 4 weeks of each itervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start4 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight AdultsStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppina Costabile, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806383
- Sponsor's protocol ID
- 58/2025
- Acronym
- SUGAR-SYN BC3O
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07806383
- Acronym / sponsor ID
- SUGAR-SYN BC3O / 58/2025
- Conditions
- Overweight Adults
- Keywords
- Spore-forming probiotic, Overweight, Functional sugar, Subclinical inflammation, Bacillus coagulans BC30™, Cardiometabolic risk, Gut microbiota
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional synbiotic sugar containing Bacillus coagulans BC30™ | Experimental | Dietary Supplement: Sugar-Based Synbiotic ProductParticipants consume two 5-g sachets of functional synbiotic sugar per day for 4 weeks. 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. The total daily dose is 10 g of functional sugar and 1 × 10⁹ CFU of Bacillus coagulans BC30™. |
| Matched sugar product without Bacillus coagulans BC30™ spores | Active comparator | Dietary Supplement: Inulin-Containing Sugar ProductParticipants consume two 4.4-g sachets of the active comparator sugar per day for 4 weeks. Each sachet contains 1.4 g of inulin and 3 g of sucrose but no Bacillus coagulans BC30™ spores. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index (BMI): 25-29.9 kg/m2
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugar-Based Synbiotic ProductParticipants 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. | Dietary supplement | Functional synbiotic sugar containing Bacillus coagulans BC30™ |
| Inulin-Containing Sugar ProductParticipants 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. | Dietary supplement | Matched sugar product without Bacillus coagulans BC30™ spores |
Primary outcome
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.
12 secondary outcomes
Difference Between Interventions in the Change in interleukin 6 (IL-6)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in interleukin 10 (IL-10)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in TNF-alfa
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in plasma glucose
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in plasma insulin
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the Change in HOMA-IR index
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum lipids
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum short chain fatty acids (SCFA)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting serum zonulin
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the fasting lipopolysaccharide (LPS)
Time frame: baseline and after 4 weeks of each itervention
Difference Between Interventions in the gut microbiota composition
Time frame: baseline and after 4 weeks of each itervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-Based Synbiotic Product and Inulin-Containing Sugar Product in people with Overweight Adults, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.