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

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ClinicalTrials.gov Identifier: NCT03921333
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
DR ADELE COSTABILE, 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.

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.

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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
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Body weight Measurements [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]
    Weight in kilograms

  2. Body mass Index measurements [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]
    kg/m^2

  3. Monitoring Blood pressure changes [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]
    mm/Hg

  4. 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)

  5. 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

  6. 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

  7. 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 :
  1. Dietary assessment [ Time Frame: Changes from baseline to 4 and 8 week treatment period with plant extracts ]
    Food Dietary intake analysis via DietPlan 7



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921333


Contacts
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Contact: Adele Costabile, Dr 02083923571 ext 3571 adele.costabile@roehampton.ac.uk
Contact: Enver Keleszade, Mr

Sponsors and Collaborators
University of Roehampton
Investigators
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Study Director: Adele Costabile, Dr University of Roehampton

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Responsible Party: DR ADELE COSTABILE, Director of the Study, University of Roehampton
ClinicalTrials.gov Identifier: NCT03921333     History of Changes
Other Study ID Numbers: LSC18/247
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Diseases