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Dietary InterventionsNCT04140851

Effect of Dietary Interventions on Intestinal Flora and Metabolism

A study testing Dietary fiber intervention and Normal diet in people with Dietary Interventions, run by Wuxi Hisky Medical Technology Co Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is to explore the effects of dietary intervention on the figure, fatty liver and biochemical indexes; the intestinal flora and metabolomics of the overweight and obese patients. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Dietary Interventions
What is being tested?
Dietary fiber intervention and Normal diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteChina
Study dates
1 Jul 2019to Sep 2021
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • for the overweight/obesity group. Diagnostic criteria for overweight or obesity (basis): The classification standard% for the body mass index of Chinese population [(BMI) = weight (kg)/height square (m^2)] recommended by the Working Group on Obesity of China (WGOC): obesity: BMI ≥ 28 kg/m^2; overweight: 28 kg/m^2 > BMI ≥ 24 kg/m^2; normal weight: 24 kg/m^2 > BMI ≥18.5 kg/m^2; underweight: BMI < 18.5 kg/m^2;
  • The subjects had not received weight loss treatment such as being on diet, diet drugs or surgery 6 months before the enrollment;
  • The subjects signed the informed consent form, and were able and willing to adhere to low-carbohydrate diet and receive regular call and outpatient follow-up;

Who cannot join

  • pregnant women, lactating women or women planning to get pregnant;
  • the obesity caused by endocrine system and central nervous system diseases or drugs, type 2 diabetes, autoimmune diseases and other endocrine systemic diseases;
  • history of acute or chronic infection, surgery or trauma, or history of malignant tumor;
  • severe liver and kidney dysfunction (transaminase > 2.5 times of normal upper limit); creatinine: male ≥ 133 μmol/L; female ≥ 124 μmol/L;
  • the patients with severe heart, brain or peripheral vascular diseases;
  • Those unable to cooperate with the observer for various reasons.
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  • The subjects withdrew from the criteria:
  • being unable to continue the intervention due to other reasons or diseases during the treatment;
  • being unsatisfied with the improvement in the symptoms during the treatment and requiring to stop the trial;
  • having serious adverse events or adverse reactions, and the investigator considers it is necessary for the subject to terminate the trial from the medical perspective.

Trial locations and contacts

1 site in 1 country.

Fuqiang Liu contact

18560083993

54669716@qq.com

China1 site, 1 recruiting
  • Liu Fuqiang

    Jinan, Shandong

    Fuqiang Liu, 18560083993, 54669716@qq.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Dietary Interventions in Overweight and Obese Patients

This study is to explore the effects of dietary intervention on the figure, fatty liver and biochemical indexes; the intestinal flora and metabolomics of the overweight and obese patients.

This study was a clinical control and self-control study (before and after), which enrolled 12 patients with simple overweight or obesity, including 9 males and 3 females. In addition, 20 patients with simple overweight or obesity were randomly selected by comparable age and gender to the control group (excluding criteria), including 11 males and 9 females, and another 20 healthy people were recruited to the healthy control group from the Physical Examination Center, Qilu Hospital of Shandong University.

Read the detailed description

With the rapid development of China's economy, changes in the residents' living habits and lifestyles, increase in dietary calorie intake, and relative decrease in physical activity, the prevalence of overweight and obesity in China has increased year by year. According to the WGOC diagnostic criteria, the prevalence of overweight and obesity in China was 31.4% and 12.2%, respectively, by 2013. The obesity refers to the chronic metabolic disease caused by the combined action of both genetic and environmental factors. It refers to the weight gain caused by the increase of body fat volume and/or increase of the number of fat cells resulted from the imbalance of energy metabolism, and caloric intake exceeding the calorie consumption. With the prevalence of obesity in the world, the obesity-related chronic diseases have gradually entered the vision of the public, such as non-alcoholic fatty liver disease (NAFLD). The NAFLD refers to the acquired metabolic stress-induced liver injury with diffuse hepatocyte macrobubble fat as clinical pathological syndrome caused by well-defined liver damage factors other than alcohol. It is the most common cause of chronic liver disease in Western countries and also the leading cause for the onset of and death from liver related disease worldwide. The NAFLD is growing rapidly in Asian countries at younger ages. With the increase of obesity rate in the country, the prevalence rate of adult NAFLD in China has also increased rapidly, with the prevalence rate as high as 30% in some areas, and more and more viral hepatitis cases are combined with NAFLD. Therefore, it can be seen that the obesity not only seriously endangers the physical and mental health of the people, but also becomes an important social public health problem that causes disability, affects the quality of life and increases the financial burden of the state. In view of the great harms brought by the obesity, to find a healthy, safe and effective weight loss method has become a public concern and study hotspot. At present, various weight loss treatment methods are available, including dietary control, exercise, and medical and surgical treatment. Each method has its own advantages and disadvantages. The lifestyle intervention based on scientific and rational nutrition therapy combined with exercise is still the safest and most effective weight loss method.

Various methods to lose weight are available so far, such as the dietary control, proper exercise, medical therapy and lately popular gastrointestinal minimally invasive surgery, and each method has its own advantages and disadvantages. The diet drug suppresses the appetite and reduces weight mainly via either central or peripheral means. In the past few decades, many diet drugs have been marketed, such as Phentermine and Sibutramine, etc., but they were soon removed from the market due to limited efficacy, various side effects and addiction, etc. The diet drugs have poor safety and high rebound rate, which also causes serious damage to the body while reducing weight. For the patients with severe obesity, existing surgical procedures, such as volume-limiting surgery, gastric bypass surgery, and the new therapy approved by the FDA in 2014 - vagus nerve block surgery, etc. are really an effective method to lose weight. However, for the patients with overweight and mild obesity, the long-term effects of surgical treatment and postoperative complications prevent them from being used as the preferred method for weight loss. Therefore, the lifestyle intervention based on scientific and rational nutrition therapy and exercise is still the safest and most effective weight loss method so far.

The dietary fiber has been neglected for a period of time for being considered "nutrient-free", and because it is usually the oligosaccharide or polysaccharide that is difficult for digestion and absorption to provide energy to the body. But now more and more studies have shown that dietary fiber is beneficial to intestinal health of human body. The fermented products from dietary fiber, such as short-chain fatty acids (SCFA), can prevent the obesity by regulating appetite, increasing anorexia hormone level and increasing energy consumption, and the addition of soluble dietary fiber to the diet can improve the anthropometric measurements in the overweight or obese patients, and help reduce BMI, the fat, and fasting blood glucose and fasting insulin levels.

The microbial diversity sequencing is the high-throughput sequencing of 16SrDNA hypervariable region of sample bacteria using the new-generation high-throughput sequencing technology (NGS), which is designated to reveal the diversity and structural composition of microbial communities and explore the relationship between the microorganisms and the hosts, so as to provide a theoretical basis for follow-up disease diagnosis and development of microbial resources.

The transient elastography (TE) FibroTouch reflects the degree of hepatic steatosis by measuring the ultrasound attenuation parameters (UAP) of the liver. It is non-invasive, simple, fast, easily operable, repeatable, safe and well tolerable.

The aim of this study is to explore the effects of dietary intervention on the figure, fatty liver and biochemical indexes; the intestinal flora and metabolomics of the overweight and obese patients.

This study was a clinical control and self-control study (before and after), which enrolled 12 patients with simple overweight or obesity, including 9 males and 3 females. In addition, 20 patients with simple overweight or obesity were randomly selected by comparable age and gender to the control group (excluding criteria), including 11 males and 9 females, and another 20 healthy people were recruited to the healthy control group from the Physical Examination Center, Qilu Hospital of Shandong University. Study methods include clinical data collection, FibroTouch detection, stool test, measurement of serum biochemical indicators and analysis of the composition of immune cells in peripheral blood.

Being tested
Dietary fiber intervention, Normal diet
Keywords
Dietary Interventions, Intestinal Flora, Metabolism

What participants receive

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

  • Dietary fiber interventionDietary supplement

    Dietary intervention

  • Normal dietDietary supplement

    Normal diet

Study groups in NCT04140851
Study groupRoleWhat they receive
overweight/obesity diet intervention groupExperimentalDietary fiber intervention
Receives: Dietary Supplement: Dietary fiber intervention
overweight/obese normal diet groupPlacebo comparatorNormal diet
Receives: Dietary Supplement: Normal diet
healthy control groupNo interventionHealthy people

What is being measured

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

  1. The value of Ultrasound Attentunation Parameter in the overweight and obese patients

    Liver is detected by FibroTouch to get UAP showing liver steatosis in obesity

    Measured: 3 months

  2. The serological indexes in the overweight and obese patients

    Serological testing gets a series of serological indicator, such as AST/ALT (U/L)

    Measured: 3 months

Secondary outcomes (2)
  1. The composition of immune cells in peripheral blood of the overweight and obese patients

    Perform immune cell sorting by flow cytometry, and analyze the proportion of various immune cells; analyze the proportion of 22 kinds of immune cells

    Measured: 3 months

  2. The composition of intestinal flora of the overweight and obese patients

    Stool test gets the composition of intestinal flora.

    Measured: 3 months

Timeline

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

  1. First posted28 Oct 2019
  2. Study start1 Jul 2019
  3. Primary completionSep 2021 (estimated)
  4. Study completionSep 2021 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
this study enrolled 12 patients with simple overweight or obesity, including 9 males and 3 females. In addition, 20 patients with simple overweight or obesity were randomly selected by comparable age and gender to the control group (excluding criteria), including 11 males and 9 females, and another 20 healthy people were recruited to the healthy control group.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04140851
Sponsor's protocol ID
DIIFM-20190701
Status last verified
Oct 2019
First submitted
29 Sep 2019
Last updated
28 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Publications

  • Zhao L, Zhang F, Ding X, Wu G, Lam YY, Wang X, Fu H, Xue X, Lu C, Ma J, Yu L, Xu C, Ren Z, Xu Y, Xu S, Shen H, Zhu X, Shi Y, Shen Q, Dong W, Liu R, Ling Y, Zeng Y, Wang X, Zhang Q, Wang J, Wang L, Wu Y, Zeng B, Wei H, Zhang M, Peng Y, Zhang C. Gut bacteria selectively promoted by dietary fibers alleviate type 2 diabetes. Science. 2018 Mar 9;359(6380):1151-1156. doi: 10.1126/science.aao5774.

    PubMed 29590046
  • Canfora EE, Meex RCR, Venema K, Blaak EE. Gut microbial metabolites in obesity, NAFLD and T2DM. Nat Rev Endocrinol. 2019 May;15(5):261-273. doi: 10.1038/s41574-019-0156-z.

    PubMed 30670819
  • Thompson SV, Hannon BA, An R, Holscher HD. Effects of isolated soluble fiber supplementation on body weight, glycemia, and insulinemia in adults with overweight and obesity: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2017 Dec;106(6):1514-1528. doi: 10.3945/ajcn.117.163246. Epub 2017 Nov 1.

    PubMed 29092878
  • Zhuang Xiaofang, et al. Evaluation of the performance of transient elastography in the diagnosis of nonalcoholic fatty liver disease. Journal of Clinical Hepatology, 33(12): 2366-2371.

  • Leng Xuejun. et al. Evaluation and comparison with FibroTouch® the degree of liver fibrosis in the patients with nonalcoholic fatty liver disease of different BMI levels. Journal of Clinical Hepatology, 34(9): 1891-1895.

Questions about this trial

What is this clinical trial studying?

A study testing Dietary fiber intervention and Normal diet in people with Dietary Interventions, run by Wuxi Hisky Medical Technology Co Ltd 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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

Contact Fuqiang Liu (18560083993, 54669716@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The value of Ultrasound Attentunation Parameter in the overweight and obese patients (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04140851, which also lists 5 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 28 Oct 2019.

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