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临床试验/NCT03921333
NCT03921333已完成不适用

Double Blind Randomised Placebo Controlled Investigation Into the Effect of Supplementing Plant Extracts on Gut Health, Immunity and Metabolic Disorders in Healthy Adults

University of Roehampton2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2019年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
2
主要终点
Monitoring Blood pressure changes

研究概览

简要总结

There is an enormous increase in diabetes mellitus worldwide, especially in developed countries. Ninety percent of diabetes cases worldwide are of Type II diabetes mellitus (T2DM) as a result of greater prevalence of sedentary lifestyle, unhealthy diet and rise of obesity, as well as an increasing number of elderly populations. T2DM can be attributed to relative deficiency of insulin involving insulin resistance, aberrant synthesis of hepatic glucose and progressive deterioration of pancreatic beta-cell functions resulting in chronic hyperglycaemia. A growing amount of evidence has emerged in the last several years linking various nutrients and food sources with a positive management of T2DM. In in vitro studies, various botanical extracts have been found to significantly inhibit the activity of alpha-glucosidase and alpha-amylase. The inhibition of these enzymes' activity is a rational approach in managing glucose level for borderline and T2DM sufferers as inhibition of both alpha-amylase and alpha-glucosidase activity can profoundly reduce post-prandial increase in blood plasma glucose concentration following a mixed carbohydrate intake. Excessive levels of blood plasma glucose and free fatty acids impose a stressful condition for pancreatic beta-cells and other insulin sensitive cells resulting in the local secretion of pro-inflammatory cytokines and chemokines causing a continuous low levels of abnormal inflammation that alter insulin's action. As the body becomes less sensitive to insulin, the resulting insulin resistance leads to further inflammation, with more inflammation causing more insulin resistance, causing blood plasma sugar levels to continuously increase, eventually resulting in T2DM. In in vitro animal models, various compounds of botanical origin have also been shown to possess anti-inflammatory activities which can be beneficial in managing T2DM.

详细描述

The aim of this human intervention study is to evaluate the impact of a botanical-based extract on gut health, immunity and metabolic disorders in healthy adults.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Females and males, aged 18 years to 65 years
  • Body Mass Index (BMI) 27-35 kg/m2
  • Not dieting within the last month and not having lost >5% body weight in the previous year
  • Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study
  • Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice
  • Able to eat most everyday foods
  • Habitually consumes three standard meals a day (i.e. breakfast, lunch and dinner)

排除标准

  • Significant health problems (e.g. hypercholesterolaemia, diabetes, GI disorders)
  • Taking any medication or supplements known to affect mineral or glucose metabolism within the past month and/or during the study
  • Pregnant, planning to become pregnant or breastfeeding
  • History of anaphylaxis to food
  • Known allergies or intolerance to foods and/or to the study materials (or closely related compounds) or any of their stated ingredients
  • BMI <27 kg/m2 or >35 kg/m2
  • Volunteers self-reporting currently dieting or having lost >5% body weight in the previous year
  • Participants with abnormal eating behaviour
  • Participation in another experimental study or receipt of an investigational drug/product within 30 days of the screening visit
  • Volunteers who have significantly changed their physical activity in the past 2-4 weeks or who intend to change them during the study
  • Participants receiving systemic or local treatment likely to interfere with the evaluation of the study parameters
  • Participants on specific food avoidance diets
  • Participants who work in appetite or feeding related areas

结局指标

主要结局

Monitoring Blood pressure changes

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

mm/Hg

Microbiota composition

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

DNA profiling from faeces (bacteria numbers/g faeces)

Body weight Measurements

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

Weight in kilograms

Modulation of blood lipids

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

Effects on TC, LDL-C, HDL-C and TAG expressed in mmol/L

Changes in insulin

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

Effect of insulin levels expressed in mg/dl

Body mass Index measurements

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

kg/m\^2

Modulation of immune function by plant extracts

时间窗: Changes from baseline to 4 and 8 week treatment period with plant extracts

Cytokines analysis on IL6,IL10, IL2 and TNFa expressed in pg/mL

次要结局

  • Dietary assessment(Changes from baseline to 4 and 8 week treatment period with plant extracts)

研究者

发起方
University of Roehampton
申办方类型
Other
责任方
Principal Investigator
主要研究者

DR ADELE COSTABILE

Director of the Study

University of Roehampton

研究点 (2)

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