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Gut MicrobiomePhase 3NCT06006416

Effect of Fenugreek Fibre on Gut Microbiome

A Phase 3 study testing Fenugreek Fibre in people with Gut Microbiome, run by RDC Clinical Pty Ltd.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Gut Microbiome
What is being tested?
Fenugreek Fibre
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2024to 1 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • 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.
  • All female participants of child bearing potential will be required to take a urine pregnancy test prior to entry into the study.
  • 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
  • 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)

About this study

Official title: 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.

Conditions
Gut Microbiome
Being tested
Fenugreek Fibre

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fenugreek FibreDrug

    Daily dose of 2 x 10g per day with/in food

Study groups in NCT06006416
Study groupRoleWhat they receive
Fenugreek FibreExperimentalFenugreek Fibre - 2 x 10g powder per day with/in food
Receives: Drug: Fenugreek Fibre

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in metagenomic profile of the gut microbiome

    Change in metagenomic profile of the gut microbiome as measured by 16s rRNA gene sequencing

    Measured: Week 0, week 4 and week 16

Secondary outcomes (18)

  1. Change in gut function

    Change in gut function as measured by faecal short change fatty acids testing via faecal sample

    Measured: Week 0, week 4 and week 16

  2. Change in intestinal permeability

    Change in intestinal permeability as measured by plasma occludin, Muc2 and Endotoxin via blood test

    Measured: Week, 0, week 4, week 8 and week 16

  3. Change in gut inflammation

    Change in gut inflammation as measured by faecal calprotectin via faecal sample

    Measured: Week 0, week 4 and week 16

  4. 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

    Measured: Week, 0, week 4, week 8 and week 16

  5. Change in GLP-1

    Change in GLP-1 as measured by blood test

    Measured: Week, 0, week 4, week 8 and week 16

  6. Change in GST

    Change in GST as measured by blood test

    Measured: Week, 0, week 4, week 8 and week 16

  7. Change in glutathione

    Change in glutathione as measured by blood test

    Measured: Week, 0, week 4, week 8 and week 16

  8. Change in FABP

    Change in FABP as measured by blood test

    Measured: Week, 0, week 4, week 8 and week 16

  9. Change in Homocysteine

    Change in Homocysteine as measured by blood test

    Measured: Week, 0, week 4, week 8 and week 16

  10. Change in diet

    Change in diet as measured by 24hr Dietary Recall

    Measured: Week 0 and Week 16 (completed for 3 consecutive days)

  11. 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.

    Measured: Week, 0, week 4, week 8 and week 16

  12. 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.

    Measured: Week, 0, week 4, week 8 and week 16

  13. 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.

    Measured: Week, 0, week 4, week 8 and week 16

  14. Change in safety

    Change in safety as measured by E/LFT via blood test

    Measured: Week 0, week 4 and week 16

  15. Height

    Height as measured by stadiometer

    Measured: Week 0, week 4 and week 16

  16. Change in weight

    Change in weight as measured by digital scale

    Measured: Week 0, week 4 and week 16

  17. Change in hip and weight circumference

    Change in hip and weight circumference as measured by tape measure

    Measured: Week 0, week 4 and week 16

  18. Change in blood pressure

    Change in blood pressure as measured by blood pressure monitor

    Measured: Week 0, week 4 and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study startDec 2024 (estimated)
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Why it stopped: The Sponsor decided not to conduct the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06006416
Sponsor's protocol ID
FENGUT
Status last verified
Nov 2023
First submitted
1 Aug 2023
Last updated
21 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fenugreek Fibre in people with Gut Microbiome, run by RDC Clinical Pty Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in metagenomic profile of the gut microbiome (time frame: Week 0, week 4 and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06006416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.

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