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

Fundació Sant Joan de Déu

Status: Enrolling

Conditions: Obesity, Adolescent; Obesity, Childhood

Treatments: Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional); Dietary Supplement: Placebo; Dietary Supplement: Postbiotic ABB C3

Study type: Interventional

Funder types: Other

Identifiers

NCT06309121

PIC-11-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Active control

Placebo Comparator group

Description:

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:

Dietary Supplement: Placebo

Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional)

Treatment

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional)

Dietary Supplement: Postbiotic ABB C3