Dietary Interventions Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02614729 -
The Consumption of Beef on Appetite and Cognitive Function
|
N/A |