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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Low dose response efficacy of plant extracts
* Dietary Supplement: Middle dose response efficacy of plant extracts
* Dietary Supplement: High Dose response efficacy of plant extracts
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria 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) Exclusion criteria 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dose response study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose plant extract<br>300 mg | Dietary Supplement: Low dose response efficacy of plant extracts<br>* 300mg<br>* Other names: Low dose;|
| Active Comparator: Middle dose plant extract<br>500 mg | Dietary Supplement: Middle dose response efficacy of plant extracts<br>* 500mg<br>* Other names: Middle dose;|
| Active Comparator: High Dose plant extract<br>700 mg | Dietary Supplement: High Dose response efficacy of plant extracts<br>* 700mg<br>* Other names: High Dose;|
| Placebo Comparator: Placebo control<br>Cellulose microcrystalline | Dietary Supplement: Placebo<br>* Cellulose microcrystalline<br>* Other names: Placebo control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight Measurements | Weight in kilograms | Changes from baseline to 4 and 8 week treatment period with plant extracts | 
| Body mass Index measurements | kg/m^2 | Changes from baseline to 4 and 8 week treatment period with plant extracts | 
| Monitoring Blood pressure changes | mm/Hg | Changes from baseline to 4 and 8 week treatment period with plant extracts | 
| Microbiota composition | DNA profiling from faeces (bacteria numbers/g faeces) | Changes from baseline to 4 and 8 week treatment period with plant extracts | 
| Modulation of blood lipids | Effects on TC, LDL-C, HDL-C and TAG expressed in mmol/L | Changes from baseline to 4 and 8 week treatment period with plant extracts | 
| Changes in insulin | Effect of insulin levels expressed in mg/dl | Changes from baseline to 4 and 8 week treatment period with plant extracts | 
| Modulation of immune function by plant extracts | Cytokines analysis on IL6,IL10, IL2 and TNFa expressed in pg/mL | Changes from baseline to 4 and 8 week treatment period with plant extracts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary assessment | Food Dietary intake analysis via DietPlan 7 | Changes from baseline to 4 and 8 week treatment period with plant extracts |