The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT03921333
• Lead Sponsor: University of Roehampton

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.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-19
• Study Start: 2019-10-28
• Primary Completion: 2023-12-28
• Study Completion: 2024-03-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Monitoring Blood pressure changes	Changes from baseline to 4 and 8 week treatment period with plant extracts	mm/Hg
Microbiota composition	Changes from baseline to 4 and 8 week treatment period with plant extracts	DNA profiling from faeces (bacteria numbers/g faeces)
Body weight Measurements	Changes from baseline to 4 and 8 week treatment period with plant extracts	Weight in kilograms
Modulation of blood lipids	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	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	Changes from baseline to 4 and 8 week treatment period with plant extracts	kg/m\^2
Modulation of immune function by plant extracts	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 Outcome Measures

Name	Time	Method
Dietary assessment	Changes from baseline to 4 and 8 week treatment period with plant extracts	Food Dietary intake analysis via DietPlan 7

Trial Locations

Locations (1)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton; 🇬🇧 London, UK, United Kingdom