The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Middle dose response efficacy of plant extractsDietary Supplement: High Dose response efficacy of plant extractsDietary Supplement: Low dose response efficacy of plant extractsDietary Supplement: Placebo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Middle dose plant extract Middle dose response efficacy of plant extracts 500 mg High Dose plant extract High Dose response efficacy of plant extracts 700 mg Low dose plant extract Low dose response efficacy of plant extracts 300 mg Placebo control Placebo Cellulose microcrystalline
- 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