AKK Study in Improving Obesity and Metabolic Status in Children and Adolescents

Summary

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 AKK bacteria on weight, metabolic health and intestinal flora of obese children and adolescents aged 7 to 18.

Conditions

• Obesity
• Obese Adolescents
• Obese Children and Adolescents
• Akkermansia Muciniphila

Interventions

BIOLOGICAL

AKK

This intervention trial intends to use pasteurized AKK bacteria, with each dose containing the equivalent of 30 billion inactivated bacterial cells. AKK bacteria are a research hotspot in the field of intestinal microecology. The pasteurized AKK bacteria (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.

DRUG

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.

Sponsors & Collaborators

• Hunan Children's Hospital

  collaborator OTHER_GOV

• Central South University

  lead OTHER

Principal Investigators

• Qian Lin, Doctor · Xiangya School of Public Health, Central South University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-06

Primary Completion

2026-12-20

Completion

2027-02-12

Countries

• China

Study Locations