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

Official title

A Randomized, Double-blind, Placebo-controlled Study of Akkermansia Muciniphila AKK PROBIO in Improving Obesity and Metabolic Abnormalities in Children and Adolescents Aged 7-18 Years

Overview

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.

Detailed description

This study aims to evaluate the improvement effect of continuous supplementation with pasteurized inactivated Akkermansia muciniphila (AKK PROBIO) for 12 weeks on the body mass index z-score of obese children and adolescents aged 7 to 18 years, and systematically explore its impact on metabolic health indicators, anthropometric indicators, and sleep, as well as to clarify the safety and tolerance of this intervention. Through the integrated analysis of metagenomics and non-targeted metabolomics, the potential mechanism by which AKK PROBIO regulate the intestinal microbiota and host metabolic profiles in children and adolescents is revealed, providing a scientific basis and biomarker support for the development of precision nutrition intervention strategies for childhood and adolescent obesity.

Interventions

• Biological 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): Th
• 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.

Primary outcome measures

• Z - score [Time frame: During the baseline period (T0), the middle period (T1, 6 weeks), and the end of the intervention (T2, 12weeks)]

Secondary outcome measures (5)

• Dietary intake [Time frame: At the baseline (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)]
• Sleep quality (13- 18 years) [Time frame: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)]
• Sleep quality (7- 12 years) [Time frame: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)]
• Gastrointestinal symptoms [Time frame: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)]
• Stool Classification [Time frame: At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)]

Eligibility criteria

Inclusion criteria

• Age range: 7 years old to 18 years old (inclusive of boundary values), gender not restricted.
• Primary obesity: According to the WS/T 586-2018 standard issued by the National Health Commission of China, or the internationally recognized CDC/WHO standard, diagnosed as obesity (if BMI ≥ the 95th percentile of children of the same age and gender).
• The subjects and their legal guardians understand the research content, voluntarily participate and sign the written informed consent form (for guardians), and the informed consent form (for children aged 8 years and above).
• Able to comply with the research protocol, complete all visits and sample collection.

Exclusion criteria

• Have a definite endocrine disorder causing obesity (such as Cushing's syndrome, hypothyroidism), a genetic syndrome (such as Prader-Willi syndrome), or other known organic diseases.
• Have a severe primary disease of the liver, kidney, cardiovascular system, respiratory system or hematopoietic system, etc.
• Have used antibiotics, probiotics, prebiotics or synbiotic products within 3 months prior to screening.
• Have a history of systemic use of glucocorticoids or other drugs that may affect weight and metabolism (such as metformin, systemic glucocorticoids, diuretics, etc.) within 1 month prior to screening.
• Subjects are allergic to any component of the study product (AKK probiotic capsules or placebo).
• Subjects are participating in other clinical trials.
• Have a history of severe gastrointestinal diseases, such as inflammatory bowel disease (IBD).
• Other conditions as determined by the researcher to be unsuitable for participation in this study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Xiangya School of Public Health — Changsha

Identifiers

NCT: NCT07593170 · HCHLL2026153

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗