Obesity, ChildhoodPostObNCT06309121
Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents
A study testing Postbiotic ABB C3 and Follow-up Postbiotic ABB C3 (Optional) in people with Obesity, Childhood and Obesity, Adolescent, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Obesity, Childhood, Obesity, Adolescent
- What is being tested?
- Postbiotic ABB C3 and Follow-up Postbiotic ABB C3 (Optional)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 10 Apr 2024to 30 Jun 2026
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 8- and 18-year-old
- Obesity (BMI-SDS > 2)
Who cannot join
- Antibiotic or pre/pro/postbiotic consumption 2 - 4 weeks prior to starting the study
- Chronic diseases affecting glucose or lipid metabolism
- Chronic medication affecting glucose or lipid metabolism, or inducing a pro-inflammatory state
- History of bariatric surgery
- Diabetes requiring insulin treatment
- Severe intellectual disability
- Pregnancy
- Individuals taking medications that may alter appetite or weight, with a recent change in prescription within the last 3 months or anticipated changes during the 2 months of participation
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat.
Read the detailed description
The study focuses on evaluating the effects of a combination of postbiotics called ABB C3 in reducing body fat and improving glucose metabolism. The study proposes a randomized, double-blind clinical trial with participants (aged 8-18 years) randomized into the ABB C3 supplement group or a placebo group. Over a period of 3 months, body composition and relevant blood parameters will be monitored (Study Phase). Subsequently, all participants will be offered to continue with the ABB C3 supplement for an additional 3 months, constituting the Follow-up Phase. The study protocol includes collecting data on possible adverse events. Blood samples and DXA scans will be performed to assess changes in body composition and metabolic health parameters. In summary, the study aims to determine the efficacy and safety of the ABB C3 postbiotic in helping reduce body fat and improve metabolic profiles in children and adolescents.
- Conditions
- Obesity, Childhood, Obesity, Adolescent
- Being tested
- Postbiotic ABB C3, Placebo, Follow-up Postbiotic ABB C3 (Optional)
- Keywords
- Obesity, Postbiotics
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postbiotic ABB C3Dietary supplement
A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study.
PlaceboDietary supplement
A daily dose of 550 mg of the placebo in individual sachets for the first 3 months of the study.
Follow-up Postbiotic ABB C3 (Optional)Dietary supplement
Option given to all participants: a daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for months 4 to 6 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Active control | Placebo comparator | Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 3 months. Participants will receive a daily dose of placebo for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months. Receives: Dietary Supplement: Placebo; Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional) |
| Treatment | Experimental | Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 3 months. Participants will receive a daily dose of postbiotic blend (ABB C3) for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months. Receives: Dietary Supplement: Postbiotic ABB C3; Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events between groups, focusing on gastrointestinal symptoms.
Measured: Baseline, 1.5 months, 3 months
Change in adiposity (% fat body mass)
Fat body mass (adiposity) will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline and 3 months and differences will be assessed
Measured: 3 months
Change in blood glycated hemoglobin (HbA1c) levels
Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.
Measured: 3 months
Secondary outcomes (9)
Change in adiposity (% fat body mass)
Fat body mass (adiposity) will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline and 6 months and differences will be assessed.
Measured: Baseline, 6 months
Change in blood glycated hemoglobin (HbA1c) levels
Blood tests will be performed at baseline and 6 months and HbA1c (%) levels quantified. Differences between time-points will be assessed.
Measured: Baseline, 6 months
Change in BMI z-score
Weight and height will be combined to calculate changes in BMI and BMI z scores and differences between time-points will be assessed.
Measured: Baseline, 1.5 months, 3 months, 6 months
Change in body composition
Body composition (lean and fat mass) will be estimated by bioimpedance and differences between time-points will be assessed.
Measured: Baseline, 1.5 months, 3 months, 6 months
Change in insulin sensitivity
Fasting blood glucose and insulin concentrations will be combined to calculate HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) and differences between time-points will be assessed
Measured: Baseline, 3 months, 6 months
Change in lipid profile (triglycerides, cholesterol)
The lipid profile will be determined by blood test and differences between time-points will be assessed
Measured: Baseline, 3 months, 6 months
Change in blood pressure
Both systolic and diastolic blood pressure will be measured at each visit and differences between time-points will be assessed
Measured: Baseline, 3 months, 6 months
Change in Beck Depression Inventory-II (BDI-2)
The Beck Depression Inventory for Youth (BDI-2) assesses negative thoughts of children or adolescents about themselves, their life, and their future, along with feelings of sadness and physiological signs of depression. It is a 20-item questionnaire with a score range of 0-60. Higher scores indicate worse outcome.
Measured: Baseline, 3 months, 6 months
Change in Beck Anxiety Inventory-II (BAI-2)
The Beck Anxiety Inventory for Youth (BAI-2) assesses the fears and concerns of children or adolescents, as well as physical symptoms associated with anxiety. It is a 20-item questionnaire with a score range of 0-60. Higher scores indicate worse outcome.
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start10 Apr 2024
- Primary completion31 Dec 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carles Lerin, PhD, Principal investigator, Fundació Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309121
- Sponsor's protocol ID
- PIC-11-24
- Acronym
- PostOb
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2024
- Last updated
- 23 Mar 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06309121
- Acronym / sponsor ID
- PostOb / PIC-11-24
- Conditions
- Obesity, Childhood, Obesity, Adolescent
- Keywords
- Obesity, Postbiotics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Mar 2024 (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 study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat.
Detailed description
The study focuses on evaluating the effects of a combination of postbiotics called ABB C3 in reducing body fat and improving glucose metabolism. The study proposes a randomized, double-blind clinical trial with participants (aged 8-18 years) randomized into the ABB C3 supplement group or a placebo group. Over a period of 3 months, body composition and relevant blood parameters will be monitored (Study Phase). Subsequently, all participants will be offered to continue with the ABB C3 supplement for an additional 3 months, constituting the Follow-up Phase. The study protocol includes collecting data on possible adverse events. Blood samples and DXA scans will be performed to assess changes in body composition and metabolic health parameters. In summary, the study aims to determine the efficacy and safety of the ABB C3 postbiotic in helping reduce body fat and improve metabolic profiles in children and adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group.
| Arm | Type | Receives |
|---|---|---|
| Active control | Placebo comparator | Dietary Supplement: Placebo, Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional)Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 3 months. Participants will receive a daily dose of placebo for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months. |
| Treatment | Experimental | Dietary Supplement: Postbiotic ABB C3, Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional)Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 3 months. Participants will receive a daily dose of postbiotic blend (ABB C3) for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 8- and 18-year-old
- Obesity (BMI-SDS > 2)
Key exclusion criteria (8 listed)
- Antibiotic or pre/pro/postbiotic consumption 2 - 4 weeks prior to starting the study
- Chronic diseases affecting glucose or lipid metabolism
- Chronic medication affecting glucose or lipid metabolism, or inducing a pro-inflammatory state
- History of bariatric surgery
- Diabetes requiring insulin treatment
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 |
|---|---|---|
| Postbiotic ABB C3A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study. | Dietary supplement | Treatment |
| PlaceboA daily dose of 550 mg of the placebo in individual sachets for the first 3 months of the study. | Dietary supplement | Active control |
| Follow-up Postbiotic ABB C3 (Optional)Option given to all participants: a daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for months 4 to 6 of the study. | Dietary supplement | Active control, Treatment |
Primary outcome
Incidence of Adverse Events
Time frame: Baseline, 1.5 months, 3 months
Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events between groups, focusing on gastrointestinal symptoms.
Change in adiposity (% fat body mass)
Time frame: 3 months
Fat body mass (adiposity) will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline and 3 months and differences will be assessed
Change in blood glycated hemoglobin (HbA1c) levels
Time frame: 3 months
Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.
9 secondary outcomes
Change in adiposity (% fat body mass)
Time frame: Baseline, 6 months
Change in blood glycated hemoglobin (HbA1c) levels
Time frame: Baseline, 6 months
Change in BMI z-score
Time frame: Baseline, 1.5 months, 3 months, 6 months
Change in body composition
Time frame: Baseline, 1.5 months, 3 months, 6 months
Change in insulin sensitivity
Time frame: Baseline, 3 months, 6 months
Change in lipid profile (triglycerides, cholesterol)
Time frame: Baseline, 3 months, 6 months
Change in blood pressure
Time frame: Baseline, 3 months, 6 months
Change in Beck Depression Inventory-II (BDI-2)
Time frame: Baseline, 3 months, 6 months
Change in Beck Anxiety Inventory-II (BAI-2)
Time frame: Baseline, 3 months, 6 months
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 23 Mar 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. This study is not recruiting at the moment.
Carles Lerin, PhD principal investigator
Fundació Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postbiotic ABB C3 and Follow-up Postbiotic ABB C3 (Optional) in people with Obesity, Childhood and Obesity, Adolescent, run by Fundació Sant Joan de Déu at 1 site in Spain.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 23 Mar 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Incidence of Adverse Events (time frame: Baseline, 1.5 months, 3 months). The study lists 3 primary outcomes in all. 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 23 Mar 2026.