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

NCT07593170 | Not Yet Recruiting Phase 2

• 1 other identifier: HCHLL2026153
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 Akkermansia Muciniphila AKK PROBIO on weight, metabolic health and intestinal flora of obese children and adolescents aged 7 to 18.

Conditions

Akkermansia Muciniphila; Obesity; Obese Adolescents; Obese Children and Adolescents

Keywords

obesity; Akkermansia muciniphila

Outcome Measures

Primary Outcomes (1)

• Z - score

  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

  During the baseline period (T0), the middle period (T1, 6 weeks), and the end of the intervention (T2, 12weeks)

Secondary Outcomes (5)

• Dietary intake

  At the baseline (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

• Sleep quality (13- 18 years)

  At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

• Sleep quality (7- 12 years)

  At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

• Gastrointestinal symptoms

  At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

• Stool Classification

  At the baseline period (T0), mid-term (T1, 6weeks), and the end of the intervention (T2, 12weeks)

Study Arms (2)

AKK Group

EXPERIMENTAL

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.

Biological: AKK

Placebo Group

PLACEBO COMPARATOR

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. Basic intervention: During the study period, both groups of subjects would receive unified and standardized health education, including the principles of balanced diet provided by registered dietitians and the physical activity suggestions provided by exercise rehabilitation specialists.

Drug: Placebo (maltodextrin)

Interventions

AKK BIOLOGICAL

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.

AKK Group

Placebo (maltodextrin) DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead
• Hunan Children's Hospital: collaborator

Study Sites (1)

Xiangya School of Public Health

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Obesity

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qian Lin, Doctor

  Xiangya School of Public Health, Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Lin, Doctor

CONTACT

+86 13874820173; linqian@csu.edu.cn

Hongmei Zhao

CONTACT

+86 13975105334; 364875977@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Xiangya School of Public Health, Central South University

Model Details: Eligible participants were randomly assigned in a 1:1 ratio to the intervention group or the placebo group using computer-generated random sequences. Stratified block randomization was used, with stratification factors including age group (7-11 years vs. 12-18 years) and gender, to ensure balanced sample sizes in both groups throughout the trial.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 18, 2026
• Study Start: June 6, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): February 12, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-06

Locations

CN (1)