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

• ClinicalTrials.gov Identifier: NCT03921333
• Recruitment Status: Active, not recruiting
• First Posted: April 19, 2019
• Last Update Posted: March 30, 2020
• Sponsor: University of Roehampton
• Information provided by (Responsible Party): DR ADELE COSTABILE, University of Roehampton

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 :

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

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

More Information

• Responsible Party: DR ADELE COSTABILE, Director of the Study, University of Roehampton
• ClinicalTrials.gov Identifier: NCT03921333
• Other Study ID Numbers: LSC18/247
• First Posted: April 19, 2019
• Last Update Posted: March 30, 2020
• Last Verified: March 2020

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

Additional relevant MeSH terms:

Metabolic Diseases