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AzTrials

ObesityNCT02539836

Study on Dietary Nutrition Intervention Techniques for Children Obesity

A study testing Dietary nutrition based on plant fermentation extract and MRI in quantifying liver fat with MRS in people with Obesity and Intestinal Bacteria Flora Disturbance, run by Chinese Academy of Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 18 yearsHealthy volunteers can take part
What is being tested?
Dietary nutrition based on plant fermentation extract and MRI in quantifying liver fat with MRS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
1 Sep 2015to 20 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shenzhen Meilin High School

    Shenzhen, Guangdong, 0755

Other trials in China

About this study

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.

Read the detailed description

Before academic examination, letter to parents, informed consent and volunteer questionnaire are released to school children and their guardians. We tell the volunteers and their guardians what about this study and invite them to participate this study. Only the volunteers and guardians signature on the letter to parents and informed consent are able to the research objects.

Experimental procedures:

Two times of medical exams, blood and stool sample collection is required for the whole experiment research. The first time exams and sample collection is carried on during academic examination; the second time is carried on after the intervention.

Recruit of research objects:

According to academic examination and volunteer questionnaires, about 300 healthy children without in taking antibiotics before 3 months are recruited and their BMI should be in the obese range. Then their waist circumference and the ratio of body fat are measured. If the ratio of waist size to weight of them is >0.46 and they have higher percentage of body fat (>20% for boys and under 12 years old girls, >25% for 12 years old girls), the data are collected and input to the database. About 40 healthy children between 15-18 years old are recruited to participate the next intervention research.

General body examination:

In academic examination, the student's basic medical data including height and weight are recorded, and then their BMI are calculated. If his/her BMI are in the obese range, his/her body composition are measured and recorded.

MRI and MRS test:

All patients underwent MRI scanning performed by an experienced technologist using a 3 Tesla MR unit (MAGNETOM Skyra, Siemens Healthcare, Erlangen, Germany). MRI and MRS were performed with multi-echo Dixon and HISTO sequences, respectively, to calculate hepatic proton density fat fraction (PDFF).

Blood collection, preservation and test:

Blood collection and preservation are proceed in standard of medical examination. When collecting the data of obesity, the tests of blood count, blood glucose, serum lipid and liver function should be processed for obese children. When intervening, more tests including blood count, blood glucose, blood lipids, liver function, hemoglobin, cytokines, insulin, high sensitivity C-reactive protein, leptin and somatomedin C should be processed.

Stool collection, preservation and detection:

50 ml centrifuge tubes are used to collect stool samples. Each tube is marked a unique encoding corresponds to a volunteer. When volunteers collecting stool samples, they transfer the stool samples into sterile centrifuge tube using sterile swabs or toothpicks as soon as possible. The collecting samples should be more than 10g. The centrifuge tubes should be put in low-temperature place , then transfer to refrigerator and stored at -80 ℃ until to DNA extraction and other testing. The tests including short chain fatty acids content (SCFA), pH, water content, immune factors sIgA and Calprotectin are processed.

16S rRNA gene sequencing of bacteria in stools:

DNA extraction:

For each sample, about 0.2g stool is weighted and the total DNA is extracted using fecal genomic DNA extraction Kit (Qiagen, model DP328). And then the concentration and purity of extracted DNA were measured using NanoDrop (Thermo, 2000C) to guarantee each sample meets the sequencing requirement.

Sample sequencing:

PCR amplification of 16S rRNA gene (V3-V4) are performed with universal forward primers 5'-ACTCCTACGGGAGGCAGCAG-3' and reverse primer 5'-GGACTACVSGGGTATCTAAT-3'. The amplification system include sterile water 19.375 ul, buffer 2.5ul, template 1ul, primers 1ul, Pyrobest DNA polymerase 0.125ul. PCR cycling conditions were as follows: 94 ℃ 5min, followed by some cycles including 94℃ denaturing for 30s, 50℃ renaturing for 30s,72℃ extending for 30s, then 72℃ extending for 5min. PCR product electrophoresis are performed to determine the appropriate PCR product with different application cycles. After connecting amplified products to tagged primers and labels, paired-end sequencing are performed with the sequencing platform of Illumina MiSeq, and the read length is about 250bp.

Intervention treatment on childhood obesity with PFE:

After 16S rRNA gene sequencing, about 40 obese volunteers in high school and with similar intestinal flora profiles are selected to participate the intervention treatment research. The intervening food is "Dr. Ephraim" plant fermentation extract (PFE). Without changing the previous diets of research objects, each research object drinks drinking 30mL PFE at morning and evening enzymes respectively, and the intervention last for 8 weeks. Before and after 8-week intervention, stool and blood samples of research objects are collected and analyzed to obtain their physiological and biochemical indexes. The all 16S rRNA gene of fecal samples in each stage are sequenced.

Being tested
Dietary nutrition based on plant fermentation extract, MRI in quantifying liver fat with MRS
Keywords
children's obesity, gut microbiome, body mass index, fruit and vegetable fermentation extraction, dietary nutrition intervention
Medical subject headings
Obesity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary nutrition based on plant fermentation extractDietary supplement

    The main ingredient of dietary nutrition is plant fermentation extraction which is from many fruit and vegetable fermented by probiotics.

  • MRI in quantifying liver fat with MRSDiagnostic test

    To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.

Study groups in NCT02539836
Study groupRoleWhat they receive
Obesity with dietary nutritionExperimentalObese children will be intervented by dietary nutrition based on plant fermentation extract for 2 months.
Receives: Dietary Supplement: Dietary nutrition based on plant fermentation extract
Liver fat of obese childrenActive comparatorTo investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.
Receives: Diagnostic Test: MRI in quantifying liver fat with MRS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI change

    Measured: 2 months

Secondary outcomes (3)
  1. Serum biomarkers change

    Measured: 2 months

  2. Weight loss

    Measured: 2 months

  3. Gut microbiome profile change

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion30 Dec 2016
  4. Study completion20 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539836
Sponsor's protocol ID
COIF_001
Status last verified
Dec 2018
First submitted
1 Sep 2015
Last updated
12 Dec 2018
Results posted
No
Data monitoring committee
No

Publications

  • Tsiros MD, Coates AM, Howe PR, Grimshaw PN, Buckley JD. Obesity: the new childhood disability? Obes Rev. 2011 Jan;12(1):26-36. doi: 10.1111/j.1467-789X.2009.00706.x.

    PubMed 20070542
  • Brien SE, Katzmarzyk PT. Physical activity and the metabolic syndrome in Canada. Appl Physiol Nutr Metab. 2006 Feb;31(1):40-7. doi: 10.1139/h05-024.

    PubMed 16604140
  • Heitmann BL, Koplan J, Lissner L. Childhood obesity: successes and failures of preventive interventions. Nutr Rev. 2009 May;67 Suppl 1:S89-93. doi: 10.1111/j.1753-4887.2009.00167.x.

    PubMed 19453687
  • Aranceta J, Moreno B, Moya M, Anadon A. Prevention of overweight and obesity from a public health perspective. Nutr Rev. 2009 May;67 Suppl 1:S83-8. doi: 10.1111/j.1753-4887.2009.00166.x.

    PubMed 19453686
  • Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002 Nov 2;360(9343):1347-60. doi: 10.1016/S0140-6736(02)11403-6.

    PubMed 12423980
  • Xu H, Li Y, Liu A, Zhang Q, Hu X, Fang H, Li T, Guo H, Li Y, Xu G, Ma J, Du L, Ma G. Prevalence of the metabolic syndrome among children from six cities of China. BMC Public Health. 2012 Jan 6;12:13. doi: 10.1186/1471-2458-12-13.

    PubMed 22225617
  • Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.

    PubMed 9302300
  • Musso G, Gambino R, Cassader M. Obesity, diabetes, and gut microbiota: the hygiene hypothesis expanded? Diabetes Care. 2010 Oct;33(10):2277-84. doi: 10.2337/dc10-0556.

    PubMed 20876708
  • Smith JD, Montano Z, Dishion TJ, Shaw DS, Wilson MN. Preventing weight gain and obesity: indirect effects of the family check-up in early childhood. Prev Sci. 2015 Apr;16(3):408-19. doi: 10.1007/s11121-014-0505-z.

    PubMed 25263212
  • Chaput JP, Despres JP, Bouchard C, Tremblay A. Longer sleep duration associates with lower adiposity gain in adult short sleepers. Int J Obes (Lond). 2012 May;36(5):752-6. doi: 10.1038/ijo.2011.110. Epub 2011 Jun 7.

    PubMed 21654631
  • Zemel MB, Thompson W, Milstead A, Morris K, Campbell P. Calcium and dairy acceleration of weight and fat loss during energy restriction in obese adults. Obes Res. 2004 Apr;12(4):582-90. doi: 10.1038/oby.2004.67.

    PubMed 15090625
  • Chaput JP, Leblanc C, Perusse L, Despres JP, Bouchard C, Tremblay A. Risk factors for adult overweight and obesity in the Quebec Family Study: have we been barking up the wrong tree? Obesity (Silver Spring). 2009 Oct;17(10):1964-70. doi: 10.1038/oby.2009.116. Epub 2009 Apr 9.

    PubMed 19360005
  • Bervoets L, Van Hoorenbeeck K, Kortleven I, Van Noten C, Hens N, Vael C, Goossens H, Desager KN, Vankerckhoven V. Differences in gut microbiota composition between obese and lean children: a cross-sectional study. Gut Pathog. 2013 Apr 30;5(1):10. doi: 10.1186/1757-4749-5-10.

    PubMed 23631345
  • Backhed F, Ding H, Wang T, Hooper LV, Koh GY, Nagy A, Semenkovich CF, Gordon JI. The gut microbiota as an environmental factor that regulates fat storage. Proc Natl Acad Sci U S A. 2004 Nov 2;101(44):15718-23. doi: 10.1073/pnas.0407076101. Epub 2004 Oct 25.

    PubMed 15505215
  • Backhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. doi: 10.1073/pnas.0605374104. Epub 2007 Jan 8.

    PubMed 17210919

Questions about this trial

What is this clinical trial studying?

A study testing Dietary nutrition based on plant fermentation extract and MRI in quantifying liver fat with MRS in people with Obesity and Intestinal Bacteria Flora Disturbance, run by Chinese Academy of Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI change (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539836, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2018.

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