HealthyGHIMDNCT03921333
The Effect of a Botanical Plant Extract on Gut Health, Immunity and Metabolic Disorders in Healthy Adults
A study testing Low dose response efficacy of plant extracts, Middle dose response efficacy of plant extracts and High Dose response efficacy of plant extracts in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low dose response efficacy of plant extracts, Middle dose response efficacy of plant extracts and High Dose response efficacy of plant extracts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2019to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Low dose response efficacy of plant extracts, Middle dose response efficacy of plant extracts, High Dose response efficacy of plant extracts, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose response efficacy of plant extractsDietary supplement
Also called Low dose
300mg
Middle dose response efficacy of plant extractsDietary supplement
Also called Middle dose
500mg
High Dose response efficacy of plant extractsDietary supplement
Also called High Dose
700mg
PlaceboDietary supplement
Also called Placebo control
Cellulose microcrystalline
| Study group | Role | What they receive |
|---|---|---|
| Low dose plant extract | Active comparator | 300 mg Receives: Dietary Supplement: Low dose response efficacy of plant extracts |
| Middle dose plant extract | Active comparator | 500 mg Receives: Dietary Supplement: Middle dose response efficacy of plant extracts |
| High Dose plant extract | Active comparator | 700 mg Receives: Dietary Supplement: High Dose response efficacy of plant extracts |
| Placebo control | Placebo comparator | Cellulose microcrystalline Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight Measurements
Weight in kilograms
Measured: Changes from baseline to 4 and 8 week treatment period with plant extracts
Body mass Index measurements
kg/m^2
Measured: Changes from baseline to 4 and 8 week treatment period with plant extracts
Monitoring Blood pressure changes
mm/Hg
Measured: Changes from baseline to 4 and 8 week treatment period with plant extracts
Microbiota composition
DNA profiling from faeces (bacteria numbers/g faeces)
Measured: 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
Measured: Changes from baseline to 4 and 8 week treatment period with plant extracts
Changes in insulin
Effect of insulin levels expressed in mg/dl
Measured: 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
Measured: Changes from baseline to 4 and 8 week treatment period with plant extracts
Secondary outcomes (1)
Dietary assessment
Food Dietary intake analysis via DietPlan 7
Measured: Changes from baseline to 4 and 8 week treatment period with plant extracts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start28 Oct 2019
- Primary completion28 Dec 2023
- Study completion25 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose response study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Adele Costabile, Dr, Study director, University of RoehamptonSteve Trangmar, Dr, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921333
- Sponsor's protocol ID
- LSC18/247
- Acronym
- GHIMD
- Status last verified
- Jul 2024
- First submitted
- 12 Apr 2019
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03921333
- Acronym / sponsor ID
- GHIMD / LSC18/247
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Dec 2023 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Dose response study
| Arm | Type | Receives |
|---|---|---|
| Low dose plant extract | Active comparator | Dietary Supplement: Low dose response efficacy of plant extracts300 mg |
| Middle dose plant extract | Active comparator | Dietary Supplement: Middle dose response efficacy of plant extracts500 mg |
| High Dose plant extract | Active comparator | Dietary Supplement: High Dose response efficacy of plant extracts700 mg |
| Placebo control | Placebo comparator | Dietary Supplement: PlaceboCellulose microcrystalline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose response efficacy of plant extractsAlso: Low dose300mg | Dietary supplement | Low dose plant extract |
| Middle dose response efficacy of plant extractsAlso: Middle dose500mg | Dietary supplement | Middle dose plant extract |
| High Dose response efficacy of plant extractsAlso: High Dose700mg | Dietary supplement | High Dose plant extract |
| PlaceboAlso: Placebo controlCellulose microcrystalline | Dietary supplement | Placebo control |
Primary outcome
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
1 secondary outcome
Dietary assessment
Time frame: Changes from baseline to 4 and 8 week treatment period with plant extracts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Costabile, Dr study director
University of Roehampton
Steve Trangmar, Dr study director
University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose response efficacy of plant extracts, Middle dose response efficacy of plant extracts and High Dose response efficacy of plant extracts in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight Measurements (time frame: Changes from baseline to 4 and 8 week treatment period with plant extracts). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.