NCT02539836

Study on Dietary Nutrition Intervention Techniques for Children Obesity

Completed NA Last updated 12 December 2018

What this trial tests

NA trial testing Dietary nutrition based on plant fermentation extract in Obesity in 90 participants. Completed in 20 July 2018.

Timeline

1 September 2015

Primary endpoint
30 December 2016

20 July 2018

Quick facts

Lead sponsor	Chinese Academy of Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	90
Start date	1 September 2015
Primary completion	30 December 2016
Estimated completion	20 July 2018
Sites	1 location across China

Drugs / interventions tested

• Dietary nutrition based on plant fermentation extract
• MRI in quantifying liver fat with MRS

Conditions studied

• Obesity — all drugs for Obesity →
• Intestinal Bacteria Flora Disturbance — all drugs for Intestinal Bacteria Flora Disturbance →
• Body Weight — all drugs for Body Weight →

Sponsor

Chinese Academy of Sciences — full company profile →

Who can join

Adults 15 to 18, any sex, with Obesity or Intestinal Bacteria Flora Disturbance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

With the rapid development of society and economy, children's simple obesity is the rising in the world and has become a chronic disease which is one of the biggest public health challenges in the world. It is a serious threat to the health of children and their adulthood. The overweight and obesity is induced by the genetic and environmental factors. The environmental factors are very important, while the dietary factors are the driving factors of many chronic diseases including obesity. This study focus on the dietary intervention of childhood obesity to build healthy intestinal flora. The interventing food was based on a natural health food - fruit and vegetable fermentation liquid, and combined with other probiotic dietary factors, dietary fiber and oligosaccharides. The implementation of the study will help to reveal the fuction mechanism of intestinal bacteria in the obese children and normal children, and to construct healthy micro environment of intestinal flor. According to the positive effect factors, the study will propose a healthy diet and nutrition intervention model for obese children, which is significant to social health especially to children's health.

To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference. A secondary goal was to assess the prevalence of nonalcoholic fatty liver disease in overweight and obese Chinese children and adolescents.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gut microbiome biomarkers in adolescent obesity: a regional study.
   Gao XF, Wu BB, Pan YL, Zhou SM, et al · · 2023 · cited 4× · PMID 37602197 · DOI 10.1007/s13755-023-00236-9