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NCT Number: NCT03921333

The Effect of a Botanical Plant Extract 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, SW15 4JD, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low dose response efficacy of plant extracts

Dietary Supplement

300mg

Other names: Low dose

Middle dose response efficacy of plant extracts

Dietary Supplement

500mg

Other names: Middle dose

High Dose response efficacy of plant extracts

Dietary Supplement

700mg

Other names: High Dose

Placebo

Dietary Supplement

Cellulose microcrystalline

Other names: Placebo control

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Official study title

Double Blind Randomised Placebo Controlled Investigation Into the Effect of Supplementing Plant Extracts on Gut Health, Immunity and Metabolic Disorders in Healthy Adults

Acronym: GHIMD

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Apr 19, 2019
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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