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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-28

Study Completion Date

2024-03-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Proprietary Botanical Blend on Glycemic Control and Post-prandial Carbohydrate Absorption

NCT03897517

Hyperglycemia Carbohydrate Insulin Resistance +1 more

UNKNOWN NA

RCT of a Polyherbal Dietary Supplement for Prediabetes

NCT03388762

Prediabetic State

COMPLETED NA

Efficacy Assessment of Chinese Herbal Medicine Jiangtang Tiaozhi Recipe Treating Participants With Glucose and Lipid Metabolism Disturbances

NCT04623567

Type2 Diabetes Dyslipidemias

UNKNOWN PHASE1/PHASE2

Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects

NCT03310359

Metabolic Syndrome X

COMPLETED NA

Assessing the Effects of a Buckwheat Beverage on Postprandial Glucose Metabolism on Healthy and T2D Individuals

NCT03923205

Healthy Type2 Diabetes

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dose response study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.