Clinical trial
AKK Study in Improving Obesity and Metabolic Status in Children and Adolescents
Opening soon · Phase 2 · 1 countries · Registry ID NCT07593170
What this study is about
The problem of obesity among children and adolescents is becoming increasingly serious and may affect their health in adulthood. Researches have found that a type of probiotic in the intestinal tract - "Akkermansia muciniphila" (referred to as AKK), may help regulate metabolism and weight. Although it has shown effects in adults, its safety and efficacy in children and adolescents still need further verification. This study aims to evaluate the effects of supplementing Akkermansia Muciniphila AKK PROBIO on weight, metabolic health and intestinal flora of obese children and adolescents aged 7 to 18.
Basic eligibility
Full registry criteria
Treatments and study arms
AKK
This intervention trial intends to use pasteurized AKK PROBIO, with each dose containing the equivalent of 30 billion inactivated bacterial cells. AKK PROBIO is a research hotspot in the field of intestinal microecology. The pasteurized AKK PROBIO (belonging to prebiotics) have been proven to have good safety and metabolic improvement effects in adults. Compared to live bacterial preparations, the inactivated form has higher stability, a longer shelf life, and better safety. AKK group (n=50): The subjects take one AKK probiotic capsule orally before each breakfast and dinner every day, and the intervention lasted for 12 weeks. During the study period, both groups of participants will receive unified and standardized health education, which includes the principles of balanced diet provided by registered dietitians and the suggestions for physical activities provided by exercise rehabilitation specialists.
Placebo (maltodextrin)
Placebo group (n=50): The subjects took one placebo capsule (containing inert ingredients such as maltodextrin) identical in appearance and taste to the AKK probiotic capsules before each breakfast and dinner every day for 12 consecutive weeks. After the study ended, the subjects in the placebo group could receive the same dose and specification of AKK probiotic capsules.
Primary outcomes
The Z-score for children (Z-score) is a statistical indicator that measures the deviation of children's growth indicators such as height (in meters), weight (in kilograms), and BMI (in kg/m\^2) from the reference population of the same age and gender. It is used to assess nutritional status and growth development levels. The nutritional status can be judged by evaluating the height-for-age z-score (HAZ), weight-for-age Z-score (WAZ), and weight-for-height z-score (WHZ) of children and BMI-for-age Z-score (BMIZ). The Z-score formula is: Z = (Measured value - Average value of the reference population) / Standard deviation of the reference population. Standard: ±2 : Normal range (95% healthy children) * -2 ≤ Z \< -1: Less than Normal * Z \< -2: Growth retardation, low weight or emaciation (\<-3 is severe) * +1 ≤ Z ≤ +2: Overweight * +2 ≤ Z ≤ +3: Obesity * Z \> +3: Severe obesity
Study locations
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