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Study on Dietary Nutrition Intervention Techniques for Children Obesity

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ClinicalTrials.gov Identifier: NCT02539836
Recruitment Status : Completed
First Posted : September 3, 2015
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Shenzhen Children's Hospital
Information provided by (Responsible Party):
Yonglong Pan, Chinese Academy of Sciences

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Intestinal Bacteria Flora Disturbance Body Weight Dietary Supplement: Dietary nutrition based on plant fermentation extract Diagnostic Test: MRI in quantifying liver fat with MRS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Study on Dietary Nutrition Intervention Techniques for Children Obesity
Study Start Date : September 1, 2015
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : July 20, 2018

Arm Intervention/treatment
Experimental: Obesity with dietary nutrition
Obese children will be intervented by dietary nutrition based on plant fermentation extract for 2 months.
Dietary Supplement: Dietary nutrition based on plant fermentation extract
The main ingredient of dietary nutrition is plant fermentation extraction which is from many fruit and vegetable fermented by probiotics.

Active Comparator: Liver fat of obese children
To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.
Diagnostic Test: MRI in quantifying liver fat with MRS
To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.




Primary Outcome Measures :
  1. BMI change [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Serum biomarkers change [ Time Frame: 2 months ]
  2. Weight loss [ Time Frame: 2 months ]
  3. Gut microbiome profile change [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • People whose BMI>27 and Age between 15-18;the value of waistline/weight >0.46; the value of body composition >20%.

Exclusion Criteria:

  • People treated by antibiotic drugs in 3 months;People with gastrointestinal diseases;People with Type I diabetes, any eating disorders such as bulimia or anorexia nervosa; Prader-Willi patients and obesity is part of clinical syndrome with other disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539836


Locations
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China, Guangdong
Shenzhen Meilin High School
Shenzhen, Guangdong, China, 0755
Sponsors and Collaborators
Chinese Academy of Sciences
Shenzhen Children's Hospital
Investigators
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Study Director: Yan Liang, Ph.D Shenzhen Institutes of Advanced Technology
Publications:

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Responsible Party: Yonglong Pan, Research associate, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT02539836    
Other Study ID Numbers: COIF_001
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Keywords provided by Yonglong Pan, Chinese Academy of Sciences:
children's obesity
gut microbiome
body mass index
fruit and vegetable fermentation extraction
dietary nutrition intervention
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Body Weight
Overnutrition
Nutrition Disorders
Overweight