Effect of Fenugreek Fibre on Gut Microbiome

Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial

A open label, self-controlled trial to evaluate the effect of Fenugreek Fibre (Trigonella foenum-graecum) on the gut microbiome in generally healthy adults aged 18-65 years old.

Study Overview

• Status: Withdrawn
• Conditions: Gut Microbiome
• Intervention / Treatment: Drug: Fenugreek Fibre

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amanda Rao, PhD; Phone Number: +61 414 488 559; Email: amanda@rdcglobal.com.au
• Study Contact Backup: Name: David Briskey, PhD; Phone Number: +61 421 784 077; Email: david@rdcglobal.com.au

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • RDC Global Pty Ltd
      • Contact: Amanda Rao, PhD; Phone Number: +61 414 488 559; Email: amanda@rdcglobal.com.au
      • Contact: David Briskey, PhD; Phone Number: +61 421 784 077; Email: david@rdcglobal.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and females aged 18-65 years old
• Generally healthy
• Able to provide informed consent
• BMI > 25kg/m2
• Agree not to participate in another clinical trial while enrolled in this trial
• Agree not the change their diet or exercise while enrolled in this trial

Exclusion Criteria:

• Unstable(1) or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, lung conditions, chronic asthma and mood disorders or neurological disorders such as MS)
• Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
• Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy
• Acute sickness experienced within the past 2 months
• Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and probiotics) that alter the microbiome or gut health. Any use during the trial will result in exclusion from the study.
• Active smokers and/or nicotine or drug abuse
• Chronic alcohol use (>14 alcoholic drinks week)
• Allergic to any of the ingredients in the formula
• Pregnant(2) or lactating woman
• Females of child bearing potential not using a highly effective form of contraception(3,4) (i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon(3,4))
• People medically prescribed medications that would affect the immune and/or the inflammatory response (e.g. NSAIDs, steroids, antibiotics).
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
• Participants who have participated in any other related clinical study during the past 1 month
• People with cognitive damage
• People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year

Footnotes

1. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
2. All female participants of child bearing potential will be required to take a urine pregnancy test prior to entry into the study.
3. Examples of acceptable forms of highly effective contraception include: Established use of oral, injected or implanted hormonal methods of contraception; Placement of an intrauterine device (IUD) or intrauterine system (IUS); Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); True abstinence: When this is in line with your preferred and usual lifestyle
4. Examples of non-acceptable methods of contraception include: Condoms alone or double barrier; Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation); Withdrawal; Spermicide (as it is not approved as a method of contraception in Australia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fenugreek Fibre; Fenugreek Fibre - 2 x 10g powder per day with/in food	Drug: Fenugreek Fibre; Daily dose of 2 x 10g per day with/in food

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in metagenomic profile of the gut microbiome	Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing	Week 0, week 4 and week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gut function	Change in gut function as measured by faecal short change fatty acids testing via faecal sample	Week 0, week 4 and week 16
Change in intestinal permeability	Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test	Week, 0, week 4, week 8 and week 16
Change in gut inflammation	Change in gut inflammation as measured by faecal calprotectin via faecal sample	Week 0, week 4 and week 16
Change in inflammation	Change in inflammation as measured by inflammatory markers (IFN-g, TNF-a, il-2, MCP-2, IL-1b, TGF-b, CRP) via blood test	Week, 0, week 4, week 8 and week 16
Change in GLP-1	Change in GLP-1 as measured by blood test	Week, 0, week 4, week 8 and week 16
Change in GST	Change in GST as measured by blood test	Week, 0, week 4, week 8 and week 16
Change in glutathione	Change in glutathione as measured by blood test	Week, 0, week 4, week 8 and week 16
Change in FABP	Change in FABP as measured by blood test	Week, 0, week 4, week 8 and week 16
Change in Homocysteine	Change in Homocysteine as measured by blood test	Week, 0, week 4, week 8 and week 16
Change in diet	Change in diet as measured by 24hr Dietary Recall	Week 0 and Week 16 (completed for 3 consecutive days)
Change in quality of life	Change in quality of life as measured by the SF-36 questionnaire. Consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.	Week, 0, week 4, week 8 and week 16
Change in stress state	Change in stress as measured by the Perceived Stress Scale questionnaire. Consists of 10 items with a score range 0-40. Higher scores indicate higher perceived stress.	Week, 0, week 4, week 8 and week 16
Change in sleep quality	Change in sleep as measured by the Leeds Sleep Evaluation Questionnaire. Consists of ten questions pertaining to four consecutive aspects of sleep: getting to sleep (GTS), quality of sleep (QOS), awakening from sleep (AFS), and behaviour following wakefulness (BFW). Higher scores indicate better sleep quality.	Week, 0, week 4, week 8 and week 16
Change in safety	Change in safety as measured by E/LFT via blood test	Week 0, week 4 and week 16
Height	Height as measured by stadiometer	Week 0, week 4 and week 16
Change in weight	Change in weight as measured by digital scale	Week 0, week 4 and week 16
Change in hip and weight circumference	Change in hip and weight circumference as measured by tape measure	Week 0, week 4 and week 16
Change in blood pressure	Change in blood pressure as measured by blood pressure monitor	Week 0, week 4 and week 16

Collaborators and Investigators

• Sponsor: RDC Clinical Pty Ltd
• Investigators: Principal Investigator: Amanda Rao, PhD, RDC Clinical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FENGUT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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