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出境医 / 临床实验 / The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults (GHIMD)
The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults (GHIMD)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | 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 | Not Applicable |
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 Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 52 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Dose response study |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Double Blind Randomised Placebo Controlled Investigation Into the Effect of Supplementing Plant Extracts on Gut Health, Immunity and Metabolic Disorders in Healthy Adults |
| Actual Study Start Date : | October 28, 2019 |
| Estimated Primary Completion Date : | August 2021 |
| Estimated Study Completion Date : | December 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Low dose plant extract
300 mg
|
Dietary Supplement: Low dose response efficacy of plant extracts
300mg
Other Name: Low dose
|
|
Active Comparator: Middle dose plant extract
500 mg
|
Dietary Supplement: Middle dose response efficacy of plant extracts
500mg
Other Name: Middle dose
|
|
Active Comparator: High Dose plant extract
700 mg
|
Dietary Supplement: High Dose response efficacy of plant extracts
700mg
Other Name: High Dose
|
|
Placebo Comparator: Placebo control
Cellulose microcrystalline
|
Dietary Supplement: Placebo
Cellulose microcrystalline
Other Name: Placebo control
|
Outcome Measures
Primary Outcome Measures :
- Body weight Measurements [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]Weight in kilograms
- Body mass Index measurements [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]kg/m^2
- Monitoring Blood pressure changes [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]mm/Hg
- Microbiota composition [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]DNA profiling from faeces (bacteria numbers/g faeces)
- Modulation of blood lipids [ Time Frame: 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 [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]Effect of insulin levels expressed in mg/dl
- Modulation of immune function by plant extracts [ Time Frame: 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 :
- Dietary assessment [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]Food Dietary intake analysis via DietPlan 7
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Locations
| United Kingdom | |
| Health Sciences Research Centre, Life Sciences Department, University of Roehampton | |
| London, UK, United Kingdom, SW15 4JD | |
Sponsors and Collaborators
University of Roehampton
Investigators
| Study Director: | Adele Costabile, Dr | University of Roehampton | |
| Study Director: | Steve Trangmar, Dr | University of Roehampton |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 12, 2019 | ||||||
| First Posted Date ICMJE | April 19, 2019 | ||||||
| Last Update Posted Date | March 30, 2020 | ||||||
| Actual Study Start Date ICMJE | October 28, 2019 | ||||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
Dietary assessment [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ] Food Dietary intake analysis via DietPlan 7
|
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults | ||||||
| Official Title ICMJE | Double Blind Randomised Placebo Controlled Investigation Into the Effect of Supplementing Plant Extracts on Gut Health, Immunity and Metabolic Disorders in Healthy Adults | ||||||
| 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 Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Dose response study Masking: Double (Participant, Investigator)Primary Purpose: Treatment |
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| Condition ICMJE | Healthy | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Estimated Enrollment ICMJE |
52 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||||
| Estimated Primary Completion Date | August 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion criteria
Exclusion criteria
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United Kingdom | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03921333 | ||||||
| Other Study ID Numbers ICMJE | LSC18/247 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | DR ADELE COSTABILE, University of Roehampton | ||||||
| Study Sponsor ICMJE | University of Roehampton | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | University of Roehampton | ||||||
| Verification Date | March 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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