Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents

Obesity, Childhood Clinical Trial

— PostOb  

Official title:

Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06309121
• Other study ID #: PIC-11-24
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Fundació Sant Joan de Déu
• Contact: Marta Ramon Krauel, MD, PhD
• Phone: (+34) 932804000
• Email: marta.ramon[@]sjd.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age between 8- and 18-year-old

• Obesity (BMI-SDS > 2)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Obesity, Adolescent
• Obesity, Childhood
• Pediatric Obesity

Intervention

Dietary Supplement:
• Postbiotic ABB C3
A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study.
• Placebo
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)
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.

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Déu	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in gut microbial abundance and diversity	DNA will be isolated from fecal samples and analyzed by deep-sequencing to determine the composition, abundance, and diversity of gut microbiota.	Baseline, 3 months, 6 months
Other	Change in plasma metabolite concentrations	Metabolite concentrations in plasma samples will be measured by liquid chromatography coupled to mass spectrometry (metabolomics).	Baseline, 3 months, 6 months
Primary	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.	Baseline, 1.5 months, 3 months
Primary	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	3 months
Primary	Change in blood glycated hemoglobin (HbA1c) levels	Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.	3 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 1.5 months, 3 months, 6 months
Secondary	Change in body composition	Body composition (lean and fat mass) will be estimated by bioimpedance and differences between time-points will be assessed.	Baseline, 1.5 months, 3 months, 6 months
Secondary	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	Baseline, 3 months, 6 months
Secondary	Change in lipid profile (triglycerides, cholesterol)	The lipid profile will be determined by blood test and differences between time-points will be assessed	Baseline, 3 months, 6 months
Secondary	Change in blood pressure	Both systolic and diastolic blood pressure will be measured at each visit and differences between time-points will be assessed	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months
Secondary	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.	Baseline, 3 months, 6 months