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临床试验/NCT07505212
NCT07505212进行中(未招募)不适用

Exploring Tannin-Probiotic Interactions on Microbial Composition and Inflammatory Outcomes in Obesity

Prairie View A&M University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Levels of GT metabolites and short-chain fatty acids (SFCAs) and changes in gut microbiome using HPLC-ESI-MSⁿ and 16s rDNA sequencing, respectively.

研究概览

简要总结

The goal of this clinical trial is to understand how gallotannin-rich (GT-rich) mangoes can reduce the inflammatory markers in obese individuals in vitro. The study will also seek to explore how gallotannins are metabolized in the gut microbiome. The main questions the research aims to answer are:

  • What is the impact of GT extract from mango and Lactiplantibacillus pentosus supplementation on inflammatory biomarkers in obese individuals?
  • Does the combination of GTs and L. pentosus exhibit synergistic effects in modulating specific microbial taxa associated with obesity and inflammation compared to either intervention alone?
  • Does genetic variation among individuals with obesity account for the ability to metabolize gallotannins? Researchers will compare the effects of GT extract from mango juice, a combination of GT-rich extract, and L. pentosus probiotic supplement on samples (stool) provided by obese individuals, to samples provided by a lean control group to see if gallotannins and gallotannins + probiotic supplementation reduce inflammation in obesity.

Participants will

  • Be grouped into 4 treatment groups
  1. Mango juice only
  2. Mango + L. pentosus
  3. L. pentosus only
  4. Control (lean individuals)
  • Visit sample collection site one time during the study (week 1)

详细描述

Introduction Background Obesity is a serious, common, and expensive chronic disease, and according to a report by the Center for Disease Control and Prevention, more than 2 in 5 adults in the United States (US) live with obesity. The issue of obesity in the US is an increasing trend, as reports have shown that the prevalence of obesity among US adults aged 20 and above from 2017 to 2020 was 41.9%, rising from 30.5% in 2000. Concurrently, the prevalence of severe obesity also increased from 4.7% to 9.2%. Meaning over 100 million adults in the US are living with obesity, while more than 22 million people are living with severe obesity.

The main cause of obesity is abnormal and excessive lipid buildup in many organs and tissues, especially in the visceral or abdominal area, including white adipose tissue (WAT), which is referred to as abdominal obesity. Numerous important non-communicable diseases, such as diabetes mellitus, metabolic dysfunction-associated fatty liver disease (MAFLD), cardiovascular diseases, hypertension, and renal disorders, are significantly influenced by this type of obesity. One of the main pathogenic mechanisms in obesity has been proposed to be impaired adipogenesis, or the process of adipocyte differentiation.

Increased oxidative stress and inflammation are further characteristics of unhealthy WAT remodeling. Histological crown-like structures (CLSs) are formed when enlarged adipocytes release chemokines that attract immune cells, mainly macrophages, to encircle the adipocytes. By triggering pro-inflammatory regulators like nuclear factor-kappa B (NF-κB), which in turn boosts the production of inflammatory genes and overpowers anti-inflammatory regulators like interleukin 10 (IL10), this mechanism intensifies the hyperinflammatory state. Furthermore, reactive oxygen species (ROS)-induced oxidative stress can override antioxidant regulation, especially the nuclear factor erythroid 2-related factor 2 (NFE2L2/NRF2)-mediated expression of antioxidant genes.

Metabolic problems, such as insulin resistance, dyslipidemia, and disturbed adipogenesis, are caused by both oxidative stress and inflammation. Therefore, methods to avoid adipocyte hypertrophy, improve adipogenesis to create normal adipocytes, reverse harmful WAT remodeling, and limit oxidative stress and inflammation may be effective ways to fight obesity and metabolic syndrome.

The use of dietary intervention for obesity prevention and management has been used for many years and has been described by researchers as foundational. Consuming meals or natural products, including fruits and vegetables, that are low in energy density and high in bioactive chemicals has been suggested as a way to manage obesity and its associated issues. Edible wild fruits and vegetables from different areas are known to contain a variety of bioactive substances, including phenolics, which may have anti-inflammatory, antioxidant, and metabolic-regulating effects. Fruit extracts that contain flavonoids and polyphenols, such as quercetin, catechin, and rutin, have demonstrated positive benefits on markers of metabolic dysfunction. In animal models of obesity, they include decreases in adipocytes and macrophages, lipid buildup, visceral adipose tissue, and markers of inflammation and oxidative stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be screened by a study before being included in the study using the following inclusion criteria. Participants must be lean or obese male or female aged 18-55 years, within the BMI ranges 18- 24.9 kg/m2 (lean) and 30-40 kg/m2 (obese) will be included. Participants will be measured for anthropometric parameters such as height and weight to confirm their BMI before being registered for the study.

排除标准

  • Participants with history of acute cardiac events, stroke, or cancer, recurrent hospitalizations, drug treatment of listed conditions within 6 months before study begin, abuse of alcohol/substance, on medications against T2DM or related diseases, smoking > 1 pack/week, seizures (all within the last 6 months) will be excluded from the study.
  • Participants with history of liver, intestinal or renal dysfunction, pregnancy or lactation, allergy against GTs, mangos, history of hepatitis B, C, or HIV, use of systemic antibiotics within 1 months of screening, participation in other interventional research study, intake of herbal dietary supplements.

研究组 & 干预措施

GT extract + Lactiplantibacillus pentosus arm

Active Comparator

In this group, stool sample provided by volunteers will be treated with GT extract and L. pentosus.

干预措施: Gallotannin-rich mango (Dietary Supplement)

GT extract + Lactiplantibacillus pentosus arm

Active Comparator

In this group, stool sample provided by volunteers will be treated with GT extract and L. pentosus.

干预措施: Lactiplantibacillus pentosus (probiotic) (Dietary Supplement)

Control group

Placebo Comparator

干预措施: No Treatment Added (Other)

Gallotannin extract from mango only

Active Comparator

In this group, stool sample provided by volunteers will be treated with GT extract only.

干预措施: Gallotannin-rich mango (Dietary Supplement)

Lactiplantibacillus pentosus supplement arm

Active Comparator

In this group, stool sample provided by volunteers will be treated with L. pentosus only.

干预措施: Lactiplantibacillus pentosus (probiotic) (Dietary Supplement)

结局指标

主要结局

Levels of GT metabolites and short-chain fatty acids (SFCAs) and changes in gut microbiome using HPLC-ESI-MSⁿ and 16s rDNA sequencing, respectively.

时间窗: Baseline (for all outcome measures) End of treatment at 12 hours (in vitro assessment)

GT metabolites and short-chain fatty acids (SCFAs) will be quantified using HPLC-ESI-MSⁿ, an advanced analytical technique that integrates compound separation, ionization, and structural characterization. In this method, HPLC separates mixture components based on their chemical properties, after which electrospray ionization (ESI) converts analytes into charged ions while preserving their structure. These ions are then subjected to multi-stage mass spectrometry (MSⁿ), enabling successive fragmentation and detailed structural identification of metabolites. Changes in gut microbiome composition will be assessed using 16S rDNA sequencing, a molecular technique that identifies and characterizes bacteria based on the highly conserved 16S ribosomal RNA gene. This involves DNA extraction, PCR amplification of the 16S rRNA gene, sequencing of variable regions, and comparison with reference databases to determine microbial diversity and composition.

次要结局

未报告次要终点

研究者

发起方
Prairie View A&M University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Janet Antwi

Associate Professor

Prairie View A&M University

研究点 (1)

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