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

NCT03921333 | Completed

• 1 other identifier: LSC18/247
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Dietary assessment

  Changes from baseline to 4 and 8 week treatment period with plant extracts

Study Arms (4)

Low dose plant extract

ACTIVE COMPARATOR

300 mg

Dietary Supplement: Low dose response efficacy of plant extracts

Middle dose plant extract

ACTIVE COMPARATOR

500 mg

Dietary Supplement: Middle dose response efficacy of plant extracts

High Dose plant extract

ACTIVE COMPARATOR

700 mg

Dietary Supplement: High Dose response efficacy of plant extracts

Placebo control

PLACEBO COMPARATOR

Cellulose microcrystalline

Dietary Supplement: Placebo

Interventions

Low dose response efficacy of plant extracts DIETARY_SUPPLEMENT

300mg

Also known as: Low dose

Low dose plant extract

Middle dose response efficacy of plant extracts DIETARY_SUPPLEMENT

500mg

Also known as: Middle dose

Middle dose plant extract

High Dose response efficacy of plant extracts DIETARY_SUPPLEMENT

700mg

Also known as: High Dose

High Dose plant extract

Placebo DIETARY_SUPPLEMENT

Cellulose microcrystalline

Also known as: Placebo control

Placebo control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

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

London, UK, SW15 4JD, United Kingdom

Location

MeSH Terms

Interventions

Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Adele Costabile, Dr

  University of Roehampton

  STUDY DIRECTOR

• Steve Trangmar, Dr

  University of Roehampton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Study

Model Details: Dose response study

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 19, 2019
• Study Start: October 28, 2019
• Primary Completion: December 28, 2023
• Study Completion: March 25, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

GB (1)