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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • UK
    • London, UK, United Kingdom, SW15 4JD
      • Health Sciences Research Centre, Life Sciences Department, University of Roehampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low dose plant extract; 300 mg	Dietary supplement: Low dose response efficacy of plant extracts; 300mg; Other Names: Low dose
Active Comparator: Middle dose plant extract; 500 mg	Dietary supplement: Middle dose response efficacy of plant extracts; 500mg; Other Names: Middle dose
Active Comparator: High Dose plant extract; 700 mg	Dietary supplement: High Dose response efficacy of plant extracts; 700mg; Other Names: High Dose
Placebo Comparator: Placebo control; Cellulose microcrystalline	Dietary supplement: Placebo; Cellulose microcrystalline; Other Names: Placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Roehampton
• Investigators: Study Director: ADELE COSTABILE, Dr, University of Roehampton; Study Director: Steve Trangmar, Dr, University of Roehampton

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: LSC18/247

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No