Effect of Fenugreek Fibre on Gut Microbiome

• ClinicalTrials.gov Identifier: NCT06006416
• Recruitment Status: Withdrawn
• First Posted: August 23, 2023
• Last Update Posted: November 18, 2023
• Sponsor: RDC Clinical Pty Ltd
• Information provided by (Responsible Party): RDC Clinical Pty Ltd

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Gut Microbiome	Drug: Fenugreek Fibre	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Fenugreek Fibre (Trigonella Foenum-graecum) on the Gut Microbiome in an Adult Population - An Open Label, Self-controlled Trial
• Estimated Study Start Date: September 1, 2023
• Estimated Primary Completion Date: May 1, 2024
• Estimated Study Completion Date: September 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in metagenomic profile of the gut microbiome [ Time Frame: Week 0, week 4 and week 16 ]
   Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing

Secondary Outcome Measures :

1. Change in gut function [ Time Frame: Week 0, week 4 and week 16 ]
   Change in gut function as measured by faecal short change fatty acids testing via faecal sample
2. Change in intestinal permeability [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test
3. Change in gut inflammation [ Time Frame: Week 0, week 4 and week 16 ]
   Change in gut inflammation as measured by faecal calprotectin via faecal sample
4. Change in inflammation [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in inflammation as measured by inflammatory markers (IFN-g, TNF-a, il-2, MCP-2, IL-1b, TGF-b, CRP) via blood test
5. Change in GLP-1 [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in GLP-1 as measured by blood test
6. Change in GST [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in GST as measured by blood test
7. Change in glutathione [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in glutathione as measured by blood test
8. Change in FABP [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in FABP as measured by blood test
9. Change in Homocysteine [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
   Change in Homocysteine as measured by blood test
10. Change in diet [ Time Frame: Week 0 and Week 16 (completed for 3 consecutive days) ]
    Change in diet as measured by 24hr Dietary Recall
11. Change in quality of life [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
    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.
12. Change in stress state [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
    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.
13. Change in sleep quality [ Time Frame: Week, 0, week 4, week 8 and week 16 ]
    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.
14. Change in safety [ Time Frame: Week 0, week 4 and week 16 ]
    Change in safety as measured by E/LFT via blood test
15. Height [ Time Frame: Week 0, week 4 and week 16 ]
    Height as measured by stadiometer
16. Change in weight [ Time Frame: Week 0, week 4 and week 16 ]
    Change in weight as measured by digital scale
17. Change in hip and weight circumference [ Time Frame: Week 0, week 4 and week 16 ]
    Change in hip and weight circumference as measured by tape measure
18. Change in blood pressure [ Time Frame: Week 0, week 4 and week 16 ]
    Change in blood pressure as measured by blood pressure monitor

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Locations

Australia, Queensland

RDC Global Pty Ltd

Brisbane, Queensland, Australia, 4006

Sponsors and Collaborators

RDC Clinical Pty Ltd

Investigators

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

More Information

• Responsible Party: RDC Clinical Pty Ltd
• ClinicalTrials.gov Identifier: NCT06006416
• Other Study ID Numbers: FENGUT
• First Posted: August 23, 2023
• Last Update Posted: November 18, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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