Clinical trial NCT06309121: Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents
Official title: Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Childhood
Obesity, Adolescent
Keywords: Obesity
Postbiotics
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: Baseline, 1.5 months, 3 months
measure: Change in adiposity (% fat body mass)
timeFrame: 3 months
measure: Change in blood glycated hemoglobin (HbA1c) levels
timeFrame: 3 months
Secondary outcomes:
measure: Change in adiposity (% fat body mass)
timeFrame: Baseline, 6 months
measure: Change in blood glycated hemoglobin (HbA1c) levels
timeFrame: Baseline, 6 months
measure: Change in BMI z-score
timeFrame: Baseline, 1.5 months, 3 months, 6 months
measure: Change in body composition
timeFrame: Baseline, 1.5 months, 3 months, 6 months
measure: Change in insulin sensitivity
timeFrame: Baseline, 3 months, 6 months
measure: Change in lipid profile (triglycerides, cholesterol)
timeFrame: Baseline, 3 months, 6 months
measure: Change in blood pressure
timeFrame: Baseline, 3 months, 6 months
measure: Change in Beck Depression Inventory-II (BDI-2)
timeFrame: Baseline, 3 months, 6 months
measure: Change in Beck Anxiety Inventory-II (BAI-2)
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
measure: Change in gut microbial abundance and diversity
timeFrame: Baseline, 3 months, 6 months
measure: Change in plasma metabolite concentrations
timeFrame: Baseline, 3 months, 6 months
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Joan de Déu
Study officials:
affiliation: Fundació Sant Joan de Deu
name: Carles Lerin, PhD
role: PRINCIPAL_INVESTIGATOR
References: