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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose plant extract | Active Comparator | 300 mg |
|
| Middle dose plant extract | Active Comparator | 500 mg |
|
| High Dose plant extract | Active Comparator | 700 mg |
|
| Placebo control | Placebo Comparator | Cellulose microcrystalline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose response efficacy of plant extracts | Dietary Supplement | 300mg |
|
| 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 |
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Adele Costabile, Dr | University of Roehampton | Study Director |
| Steve Trangmar, Dr | University of Roehampton | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Research Centre, Life Sciences Department, University of Roehampton | London | UK | SW15 4JD | United Kingdom |
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Dose response study
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| Middle dose response efficacy of plant extracts | Dietary Supplement | 500mg |
|
|
| High Dose response efficacy of plant extracts | Dietary Supplement | 700mg |
|
|
| Placebo | Dietary Supplement | Cellulose microcrystalline |
|
|
| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
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