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临床试验/NCT05664321
NCT05664321已完成不适用

Red and White Meat Intake in Relation to Gut Flora in Obese and Non-Obese Arab Females

King Saud University1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Correlations between gut flora by type of meat intake in total participants

研究概览

简要总结

People who are overweight are getting more and more common in every region of the world. However, despite significant progress being made in the treatment options available for overweight, the worldwide incidence of overweight has not gone down, and the challenge of overweight has become a worrisome phenomenon of our times. Additionally, the process that underlie this illness and the etiological variables are not fully comprehended. As a result, it is absolutely necessary to determine the factors that contribute to obesity and define the responsibilities that each play. Researchers have devoted a significant portion of the better part of the last decade to studying the microbiota of the gut to determine whether or not it may play a factor in the development of obesity. Across spite of this, there is a paucity of accessible epidemiological data in Saudi Arabia. In addition, the relationship between the composition of the "gut microbiota" and obesity indices in youthful women of reproductive age is little understood. In view of this, we decided to conduct a case study utilizing whole-genome shotgun sequencing to compare the gut microbiota of obese women from Saudi Arabia with that of healthy control participants. Our findings shed light on the significance of the gut microbiota in obesity and provide useful insight into the creation of a method for the therapy of obesity by means of microbiota transfer of fecal, antibiotics, probiotics, and prebiotics. In addition, these data reveal prospective targets for guiding the selection of probiotic strains for the needed gut microbiota regulation in the obesity therapy.

详细描述

Materials and Methods

Study Design

From January 2019 to March 2020, a bigger study was carried out in the College of Applied Medical Sciences clinic located on the campus of King Saud University in Riyadh. This research will be a component of that larger study. The primary purpose of this research is to investigate the nature of the connection that exists between the microbiota in the stomach and obesity markers. The study's methodology is described in detail elsewhere. The sample size of 92 was determined in a way similar to a prior study, with the significance level set at 5% and the power set at 80%, based on the composition of the gut microbiota and its differences among Saudi women in higher education. With a 95% Confidence Interval (CI) and 80% power, we expect a Firmicutes: Bacteroidetes of 0.9:0.4 in women of normal weight and 1.7:1.7 in women with obesity. Also, people were enlisted at random using fliers, faculty aid, presentations, and social media. Participants with the following exclusionary criteria were not included in the analysis: age 18 years, being overweight, body mass index (BMI) 25-29.9 kg/m2), being pregnant, following a specific diet (e.g., a calorie-restricted diet), reporting the presence of gastrointestinal diseases in the past eight weeks, a history of endocrine or oncological disease, psychiatric disorders, anorexia, other medical conditions, or using multivitamins, vitamin B.

Each participant was given a time and date to return a stool sample to the nutrition clinic in the same College where the study was conducted, along with a container in which to store it until that time. Participants provided fasting blood samples and had their demographic, nutritional, and anthropometric information recorded. Ninety-two Saudi female students between the ages of 18 and 25 made up the final sample, and they were divided into two groups: those with obesity (BMI 30 kg/m2) (n=44) and those without (BMI=18.50-24.99 kg/m2) (n=48). The King Khalid University Hospital Institutional Review Board Committee of King Saud University gave its clearance to the study's protocol (IRB #E-19-3625).

Anthropometric Measurements

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18 to 25 years of age
  • Normal weight: body mass index (BMI): 18.00-24.99 kg/m2
  • Obese: BMI ≥ 30 kg/m2

排除标准

  • Less than 18 years old or above 25 years
  • Overweight (BMI); 25.0-29.9 kg/m2)
  • Following specific diets (e.g., calorie-restricted diets)
  • Reported the presence of gastrointestinal diseases in the past eight weeks
  • Endocrine or oncological disease history, psychiatric disorders, anorexia, other medical conditions
  • Usage of multi-vitamins or vitamin B12 and antibiotics in the past 6 months

结局指标

主要结局

Correlations between gut flora by type of meat intake in total participants

时间窗: Baseline

cross-sectional analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghadeer Aljuraiban

Associate Professor

King Saud University

研究点 (1)

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