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Clinical Trials/NCT03921333
NCT03921333
Completed
Not Applicable

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 Roehampton1 site in 1 country52 target enrollmentOctober 28, 2019
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Roehampton
Enrollment
52
Locations
1
Primary Endpoint
Monitoring Blood pressure changes
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 28, 2019
End Date
March 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Roehampton
Responsible Party
Principal Investigator
Principal Investigator

DR ADELE COSTABILE

Director of the Study

University of Roehampton

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Monitoring Blood pressure changes

Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts

mm/Hg

Microbiota composition

Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts

DNA profiling from faeces (bacteria numbers/g faeces)

Body weight Measurements

Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts

Weight in kilograms

Modulation of blood lipids

Time Frame: 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

Time Frame: 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

Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts

kg/m\^2

Modulation of immune function by plant extracts

Time Frame: 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

Secondary Outcomes

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

Study Sites (1)

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